Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02453282
Registration number
NCT02453282
Ethics application status
Date submitted
20/05/2015
Date registered
25/05/2015
Titles & IDs
Public title
Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
Query!
Scientific title
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)(MYSTIC).
Query!
Secondary ID [1]
0
0
2015-001279-39
Query!
Secondary ID [2]
0
0
D419AC00001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
MYSTIC
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-Small-Cell Lung Carcinoma NSCLC
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Paclitaxel + Carboplatin
Treatment: Drugs - Gemcitabine + Cisplatin
Treatment: Drugs - Gemcitabine + Carboplatin
Treatment: Drugs - Pemetrexed + Cisplatin
Treatment: Drugs - Pemetrexed + Carboplatin
Experimental: Monotherapy - PD-L1 monoclonal Antibody monotherapy.
Experimental: Combination Therapy - PD-L1+Tremelimumab combination therapy
Active comparator: Standard of Care - Standard of Care chemotherapy treatment
Treatment: Drugs: Paclitaxel + Carboplatin
Chemotherapy Agents
Treatment: Drugs: Gemcitabine + Cisplatin
Chemotherapy Agents
Treatment: Drugs: Gemcitabine + Carboplatin
Chemotherapy Agents
Treatment: Drugs: Pemetrexed + Cisplatin
Chemotherapy Agents
Treatment: Drugs: Pemetrexed + Carboplatin
Chemotherapy Agents
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy
Query!
Assessment method [1]
0
0
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Query!
Timepoint [1]
0
0
From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Primary outcome [2]
0
0
Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy
Query!
Assessment method [2]
0
0
The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of at least 5 millimeter (mm), taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Query!
Timepoint [2]
0
0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [1]
0
0
OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy
Query!
Assessment method [1]
0
0
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Query!
Timepoint [1]
0
0
From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [2]
0
0
OS; PD-L1 (TC >=1%) Analysis Set Population
Query!
Assessment method [2]
0
0
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Query!
Timepoint [2]
0
0
From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [3]
0
0
OS; FAS Population
Query!
Assessment method [3]
0
0
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Query!
Timepoint [3]
0
0
From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [4]
0
0
PFS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs Durvalumab Monotherapy
Query!
Assessment method [4]
0
0
The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Query!
Timepoint [4]
0
0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [5]
0
0
PFS; PD-L1 (TC >=1%) Analysis Set Population
Query!
Assessment method [5]
0
0
The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Query!
Timepoint [5]
0
0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [6]
0
0
PFS; FAS Population
Query!
Assessment method [6]
0
0
The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Query!
Timepoint [6]
0
0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [7]
0
0
Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population
Query!
Assessment method [7]
0
0
The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of Complete Response (CR) or Partial Response (PR). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Query!
Timepoint [7]
0
0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [8]
0
0
ORR; PD-L1 (TC >=1%) Analysis Set Population
Query!
Assessment method [8]
0
0
The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Query!
Timepoint [8]
0
0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [9]
0
0
ORR; FAS Population
Query!
Assessment method [9]
0
0
The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Query!
Timepoint [9]
0
0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [10]
0
0
Duration of Response (DoR); PD-L1 (TC >=25%) Analysis Set Population
Query!
Assessment method [10]
0
0
The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Query!
Timepoint [10]
0
0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [11]
0
0
DoR; PD-L1 (TC >=1%) Analysis Set Population
Query!
Assessment method [11]
0
0
The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Query!
Timepoint [11]
0
0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [12]
0
0
DoR; FAS Population
Query!
Assessment method [12]
0
0
The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).
Query!
Timepoint [12]
0
0
Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Query!
Secondary outcome [13]
0
0
Percentage of Participants Alive and Progression Free at 12 Months (APF12); PD-L1 (TC >=25%) Analysis Set Population
Query!
Assessment method [13]
0
0
The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.
Query!
Timepoint [13]
0
0
Tumour scans performed at baseline then every 6 weeks up to 12 months.
Query!
Secondary outcome [14]
0
0
Percentage of Participants APF12; PD-L1 (TC >=1%) Analysis Set Population
Query!
Assessment method [14]
0
0
The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.
Query!
Timepoint [14]
0
0
Tumour scans performed at baseline then every 6 weeks up to 12 months.
Query!
Secondary outcome [15]
0
0
Percentage of Participants APF12; FAS Population
Query!
Assessment method [15]
0
0
The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.
Query!
Timepoint [15]
0
0
Tumour scans performed at baseline then every 6 weeks up to 12 months.
Query!
Secondary outcome [16]
0
0
Time From Randomization to Second Progression (PFS2); PD-L1 (TC >=25%) Analysis Set Population
Query!
Assessment method [16]
0
0
The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.
Query!
Timepoint [16]
0
0
Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
Query!
Secondary outcome [17]
0
0
PFS2; PD-L1 (TC >=1%) Analysis Set Population
Query!
Assessment method [17]
0
0
The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.
Query!
Timepoint [17]
0
0
Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
Query!
Secondary outcome [18]
0
0
PFS2; FAS Population
Query!
Assessment method [18]
0
0
The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.
Query!
Timepoint [18]
0
0
Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).
Query!
Secondary outcome [19]
0
0
Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at 12 Months
Query!
Assessment method [19]
0
0
Patient reported outcomes for 5 disease related symptoms was assessed using the EORTC QLQ-Core 30 (C30) items questionnaire (fatigue and appetite loss) and the EORTC QLQ-Lung Cancer module 13 (LC13) (dysponea, cough and chest pain). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items with higher scores representing greater symptom severity. An improvement in symptoms were indicated by a negative change in score from baseline. A positive change in score from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change is defined as an absolute change in the score from baseline of \>=10.
Query!
Timepoint [19]
0
0
At baseline then every 4 weeks for the first 8 weeks relative to the date of randomization, then every 8 weeks until second progression/death, whichever comes first. Assessed up to 12 months.
Query!
Secondary outcome [20]
0
0
Serum Concentrations of Durvalumab
Query!
Assessment method [20]
0
0
Blood samples were collected to determine the serum concentration of durvalumab.
Query!
Timepoint [20]
0
0
Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, and at follow-up Month 3.
Query!
Secondary outcome [21]
0
0
Serum Concentrations of Tremelimumab
Query!
Assessment method [21]
0
0
Blood samples were collected to determine the serum concentration of tremelimumab.
Query!
Timepoint [21]
0
0
Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3.
Query!
Secondary outcome [22]
0
0
Maximum Serum Concentration at Steady State (Cmax_ss) of Durvalumab
Query!
Assessment method [22]
0
0
Blood samples were collected to determine the Cmax_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Query!
Timepoint [22]
0
0
Within 1 hour after end of infusion on infusion day at Week 12.
Query!
Secondary outcome [23]
0
0
Cmax_ss of Tremelimumab
Query!
Assessment method [23]
0
0
Blood samples were collected to determine the Cmax_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Query!
Timepoint [23]
0
0
Within 1 hour after end of infusion on infusion day at Week 12.
Query!
Secondary outcome [24]
0
0
Trough Serum Concentration at Steady State (Ctrough_ss) of Durvalumab
Query!
Assessment method [24]
0
0
Blood samples were collected to determine the Ctrough_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Query!
Timepoint [24]
0
0
Pre-dose at Week 12.
Query!
Secondary outcome [25]
0
0
Ctrough_ss of Tremelimumab
Query!
Assessment method [25]
0
0
Blood samples were collected to determine the Ctrough_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.
Query!
Timepoint [25]
0
0
Pre-dose at Week 12.
Query!
Secondary outcome [26]
0
0
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab
Query!
Assessment method [26]
0
0
Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against durvalumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
Query!
Timepoint [26]
0
0
At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.
Query!
Secondary outcome [27]
0
0
Number of Participants With ADA Response to Tremelimumab
Query!
Assessment method [27]
0
0
Blood samples were measured for the presence of ADAs and ADA-nAb for tremelimumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against tremelimumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
Query!
Timepoint [27]
0
0
At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.
Query!
Eligibility
Key inclusion criteria
For inclusion in the study, patients should fulfill the following criteria:
* Aged at least 18 years
* Documented evidence of Stage IV NSCLC
* No sensitizing EGFR mutation or ALK rearrangement
* No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
* World Health Organization (WHO) Performance Status of 0 or 1
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
130
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
3. Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease]
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/07/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/12/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1118
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Box Hill
Query!
Recruitment hospital [2]
0
0
Research Site - Gosford
Query!
Recruitment hospital [3]
0
0
Research Site - Kogarah
Query!
Recruitment hospital [4]
0
0
Research Site - Melbourne
Query!
Recruitment hospital [5]
0
0
Research Site - Port Macquarie
Query!
Recruitment hospital [6]
0
0
Research Site - Southport
Query!
Recruitment hospital [7]
0
0
Research Site - St Leonards
Query!
Recruitment postcode(s) [1]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [2]
0
0
2250 - Gosford
Query!
Recruitment postcode(s) [3]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [5]
0
0
2444 - Port Macquarie
Query!
Recruitment postcode(s) [6]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [7]
0
0
2065 - St Leonards
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Hawaii
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Minnesota
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Missouri
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Nebraska
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New Jersey
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
North Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Ohio
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
South Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Tennessee
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Virginia
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Wisconsin
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Brussels
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Charleroi
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Duffel
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Leuven
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Liège
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Ontario
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Saskatchewan
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Bordeaux Cedex
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Brest Cedex
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Creteil
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Lille
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Lyon Cedex 08
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Marseille cedex
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Aachen
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Bad Berka
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Berlin
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Freiburg
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Gauting
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Hamburg
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Heidelberg
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Hemer
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Homburg/Saar
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Immenhausen
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Lubeck
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Löwenstein
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Mainz
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Münster
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Oldenburg
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Ulm
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Velbert
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Würzburg
Query!
Country [50]
0
0
Hungary
Query!
State/province [50]
0
0
Budapest
Query!
Country [51]
0
0
Hungary
Query!
State/province [51]
0
0
Deszk
Query!
Country [52]
0
0
Hungary
Query!
State/province [52]
0
0
Edelény
Query!
Country [53]
0
0
Hungary
Query!
State/province [53]
0
0
Kaposvár
Query!
Country [54]
0
0
Hungary
Query!
State/province [54]
0
0
Kecskemét
Query!
Country [55]
0
0
Hungary
Query!
State/province [55]
0
0
Miskolc
Query!
Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Nyíregyháza
Query!
Country [57]
0
0
Hungary
Query!
State/province [57]
0
0
Pécs
Query!
Country [58]
0
0
Hungary
Query!
State/province [58]
0
0
Székesfehérvár
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Genova
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Meldola
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Milano
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
San Giovanni Rotondo
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Siena
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Fukushima-shi
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Himeji-shi
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Hirakata-shi
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Hirosaki-shi
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Iizuka-shi
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Iwakuni-shi
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Izumi-shi
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Kanazawa
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Kishiwada-shi
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Kobe-shi
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Koga-shi
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Kyoto-shi
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Mitaka-shi
Query!
Country [77]
0
0
Japan
Query!
State/province [77]
0
0
Nagaoka-shi
Query!
Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Nagoya-shi
Query!
Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Okayama-shi
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Osaka-shi
Query!
Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Osakasayama
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Saga-shi
Query!
Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Saitama-shi
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Sakai-shi
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Sendai-shi
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Shinjuku-ku
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Tokushima-shi
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Ube-shi
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Yokohama-shi
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Yokosuka-shi
Query!
Country [91]
0
0
Korea, Republic of
Query!
State/province [91]
0
0
Busan
Query!
Country [92]
0
0
Korea, Republic of
Query!
State/province [92]
0
0
Changwon-si
Query!
Country [93]
0
0
Korea, Republic of
Query!
State/province [93]
0
0
Cheongju-si
Query!
Country [94]
0
0
Korea, Republic of
Query!
State/province [94]
0
0
Daegu
Query!
Country [95]
0
0
Korea, Republic of
Query!
State/province [95]
0
0
Daejeon
Query!
Country [96]
0
0
Korea, Republic of
Query!
State/province [96]
0
0
Goyang-si
Query!
Country [97]
0
0
Korea, Republic of
Query!
State/province [97]
0
0
Incheon
Query!
Country [98]
0
0
Korea, Republic of
Query!
State/province [98]
0
0
Jinju-si
Query!
Country [99]
0
0
Korea, Republic of
Query!
State/province [99]
0
0
Seongnam-si
Query!
Country [100]
0
0
Korea, Republic of
Query!
State/province [100]
0
0
Seongnam-Si
Query!
Country [101]
0
0
Korea, Republic of
Query!
State/province [101]
0
0
Seoul
Query!
Country [102]
0
0
Korea, Republic of
Query!
State/province [102]
0
0
Suwon-si
Query!
Country [103]
0
0
Korea, Republic of
Query!
State/province [103]
0
0
Ulsan
Query!
Country [104]
0
0
Netherlands
Query!
State/province [104]
0
0
Amsterdam
Query!
Country [105]
0
0
Netherlands
Query!
State/province [105]
0
0
Arnhem
Query!
Country [106]
0
0
Netherlands
Query!
State/province [106]
0
0
Breda
Query!
Country [107]
0
0
Netherlands
Query!
State/province [107]
0
0
Den Bosch
Query!
Country [108]
0
0
Netherlands
Query!
State/province [108]
0
0
Groningen
Query!
Country [109]
0
0
Netherlands
Query!
State/province [109]
0
0
Maastricht
Query!
Country [110]
0
0
Netherlands
Query!
State/province [110]
0
0
Rotterdam
Query!
Country [111]
0
0
Russian Federation
Query!
State/province [111]
0
0
Moscow
Query!
Country [112]
0
0
Russian Federation
Query!
State/province [112]
0
0
Obninsk
Query!
Country [113]
0
0
Russian Federation
Query!
State/province [113]
0
0
Omsk
Query!
Country [114]
0
0
Russian Federation
Query!
State/province [114]
0
0
Saint Petersburg
Query!
Country [115]
0
0
Russian Federation
Query!
State/province [115]
0
0
Saint-Petersburg
Query!
Country [116]
0
0
Russian Federation
Query!
State/province [116]
0
0
St. Petersburg
Query!
Country [117]
0
0
Spain
Query!
State/province [117]
0
0
A Coruña
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Alicante
Query!
Country [119]
0
0
Spain
Query!
State/province [119]
0
0
Barcelona
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
Gerona
Query!
Country [121]
0
0
Spain
Query!
State/province [121]
0
0
Jaén
Query!
Country [122]
0
0
Spain
Query!
State/province [122]
0
0
León
Query!
Country [123]
0
0
Spain
Query!
State/province [123]
0
0
Madrid
Query!
Country [124]
0
0
Spain
Query!
State/province [124]
0
0
Majadahonda
Query!
Country [125]
0
0
Spain
Query!
State/province [125]
0
0
Málaga
Query!
Country [126]
0
0
Spain
Query!
State/province [126]
0
0
Sevilla
Query!
Country [127]
0
0
Spain
Query!
State/province [127]
0
0
Valencia
Query!
Country [128]
0
0
Switzerland
Query!
State/province [128]
0
0
Bellinzona
Query!
Country [129]
0
0
Switzerland
Query!
State/province [129]
0
0
Lausanne
Query!
Country [130]
0
0
Taiwan
Query!
State/province [130]
0
0
Kaohsiung
Query!
Country [131]
0
0
Taiwan
Query!
State/province [131]
0
0
Taichung
Query!
Country [132]
0
0
Taiwan
Query!
State/province [132]
0
0
Tainan City
Query!
Country [133]
0
0
Taiwan
Query!
State/province [133]
0
0
Taipei
Query!
Country [134]
0
0
Taiwan
Query!
State/province [134]
0
0
Tao-Yuan
Query!
Country [135]
0
0
Thailand
Query!
State/province [135]
0
0
Bangkok
Query!
Country [136]
0
0
Thailand
Query!
State/province [136]
0
0
Chiang Mai
Query!
Country [137]
0
0
Thailand
Query!
State/province [137]
0
0
Hat Yai
Query!
Country [138]
0
0
Thailand
Query!
State/province [138]
0
0
Khon Kaen
Query!
Country [139]
0
0
Vietnam
Query!
State/province [139]
0
0
Hanoi City
Query!
Country [140]
0
0
Vietnam
Query!
State/province [140]
0
0
Hanoi
Query!
Country [141]
0
0
Vietnam
Query!
State/province [141]
0
0
Ho Chi Minh city
Query!
Country [142]
0
0
Vietnam
Query!
State/province [142]
0
0
Ho Chi Minh
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC
Query!
Trial website
https://clinicaltrials.gov/study/NCT02453282
Query!
Trial related presentations / publications
Garon EB, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, Robinet G, Le Moulec S, Natale R, Schneider J, Shepherd FA, Garassino MC, Geater SL, Szekely ZP, Van Ngoc T, Liu F, Scheuring U, Patel N, Peters S, Rizvi NA. Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC). Clin Lung Cancer. 2021 Jul;22(4):301-312.e8. doi: 10.1016/j.cllc.2021.02.010. Epub 2021 Feb 19. Rizvi NA, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, van den Heuvel MM, Cobo M, Vicente D, Smolin A, Moiseyenko V, Antonia SJ, Le Moulec S, Robinet G, Natale R, Schneider J, Shepherd FA, Geater SL, Garon EB, Kim ES, Goldberg SB, Nakagawa K, Raja R, Higgs BW, Boothman AM, Zhao L, Scheuring U, Stockman PK, Chand VK, Peters S; MYSTIC Investigators. Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):661-674. doi: 10.1001/jamaoncol.2020.0237. Erratum In: JAMA Oncol. 2020 Nov 1;6(11):1815. doi: 10.1001/jamaoncol.2020.5538.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Stuart McIntosh, MD
Query!
Address
0
0
AstraZeneca, Alderley Park, Cheshire, UK
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/82/NCT02453282/Prot_015.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/82/NCT02453282/SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02453282