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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02352948
Registration number
NCT02352948
Ethics application status
Date submitted
28/01/2015
Date registered
2/02/2015
Date last updated
11/10/2023
Titles & IDs
Public title
A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
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Scientific title
A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC).
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Secondary ID [1]
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2014-000338-46
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Secondary ID [2]
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D4191C00004
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Universal Trial Number (UTN)
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Trial acronym
ARCTIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non - Small Cell Lung Cancer NSCLC
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MEDI4736 (durvalumab)
Treatment: Drugs - Vinorelbine
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Erlotinib
Treatment: Drugs - MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)
Treatment: Drugs - tremelimumab (anti-CTLA4)
Experimental: MEDI4736 (durvalumab) monotherapy in Sub-study A - MEDI4736 (durvalumab) by intravenous infusion. Sub-study A for patients with PD-L1 positive tumors.
Active Comparator: Standard of Care in Sub-study A - Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study A for patients with PD-L1 positive tumors.
Experimental: MEDI4736 (durvalumab) + tremelimumab in Sub-study B - MEDI4736 (durvalumab) by intravenous infusion and tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.
Active Comparator: Standard of Care in Sub-study B - Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study B for patients with PD-L1 negative tumors.
Experimental: MEDI4736 (durvalumab) monotherapy in Sub-study B - MEDI4736 (durvalumab) by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.
Experimental: tremelimumab in Sub-study B - tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.
Treatment: Drugs: MEDI4736 (durvalumab)
MEDI4736 (durvalumab) treatment by intravenous infusion
Treatment: Drugs: Vinorelbine
Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.
Treatment: Drugs: Gemcitabine
Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.
Treatment: Drugs: Erlotinib
Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration
Treatment: Drugs: MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)
MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion
Treatment: Drugs: tremelimumab (anti-CTLA4)
tremelimumab (anti-CTLA4) treatment by intravenous infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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The OS was defined as the time from the date of randomization until death due to any cause.
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Timepoint [1]
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From randomization (Day 1) until death due to any cause, approximately 36 months
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Primary outcome [2]
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Progression-Free Survival (PFS)
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Assessment method [2]
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The PFS 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 withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to response evaluation criteria in solid tumours (RECIST) version 1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion
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Timepoint [2]
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Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.
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Secondary outcome [1]
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OS, Contribution of the Components Analysis of Sub-study B
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Assessment method [1]
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The OS was defined as the time from the date of randomization until death due to any cause.
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Timepoint [1]
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From randomization (Day 1) until death due to any cause, approximately 36 months
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Secondary outcome [2]
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Percentage of Participants Alive at 12 Months (OS12)
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Assessment method [2]
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The OS12 was defined as the percentage of participants who were alive at 12 months after randomisation per Kaplan-Meier estimate of OS at 12 months.
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Timepoint [2]
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From randomization (Day 1) up to 12 months
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Secondary outcome [3]
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PFS, Contribution of the Components Analysis of Sub-study B
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Assessment method [3]
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The PFS 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 withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion
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Timepoint [3]
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Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.
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Secondary outcome [4]
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Objective Response Rate (ORR)
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Assessment method [4]
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The ORR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) among ITT participants who had measurable disease at baseline. CR was defined as disappearance of all target lesions (any pathological lymph nodes selected as target lesions 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 target lesions (taking as reference the baseline sum of diameters as long as criteria for PD are not met). The ORR was measured using Investigator assessments according to RECIST v1.1.
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Timepoint [4]
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Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.
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Secondary outcome [5]
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Duration of Response (DoR)
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Assessment method [5]
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The DoR 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. The DoR was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion
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Timepoint [5]
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Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.
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Secondary outcome [6]
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Percentage of Participants Alive and Progression Free at 6 Months (APF6)
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Assessment method [6]
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The APF6 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 6 months after randomization per Kaplan-Meier estimate of PFS at 6 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion
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Timepoint [6]
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Tumour scans performed at baseline then every ~8 weeks up to 6 months
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Secondary outcome [7]
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Percentage of Participants Alive and Progression Free at 12 Months (APF12)
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Assessment method [7]
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The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion
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Timepoint [7]
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Tumour scans performed at baseline then every ~8 weeks up to 12 months.
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Secondary outcome [8]
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Time From Randomisation to Second Progression (PFS2) of Sub-study B
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Assessment method [8]
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The PFS2 was defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the PFS endpoint or death and determined by local standard clinical practice and have included any of the following: objective radiological, symptomatic progression, or death. PFS2 was reported for sub-study B only.
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Timepoint [8]
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Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. Disease then assessed per local practice until 2nd progression. Assessed up to a maximum of approximately 3 years.
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Eligibility
Key inclusion criteria
- Aged at least 18 years
- Documented evidence of NSCLC (Stage IIIB/ IV disease)
- Disease progression or recurrence after both a platinum-based chemotherapy regimen and
at least 1 additional regimen for treatment of NSCLC
- World Health Organization (WHO) Performance Status of 0 or 1
- Estimated life expectancy more than 12 weeks
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Minimum age
18
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Maximum age
130
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4
- Brain metastases or spinal cord compression unless asymptomatic, treated and stable
(not requiring steroids)
- Active or prior documented autoimmune disease within the past 2 years
- Evidence of severe or uncontrolled systemic disease, including active bleeding
diatheses or active infections including hepatitis B, C and HIV
- Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2
from previous anti-cancer therapy
- Known EGFR TK activating mutations or ALK rearrangements
- Any prior Grade =3 immune-related adverse event (irAE) while receiving any previous
immunotherapy agent, or any unresolved irAE >Grade 1
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative
colitis)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/08/2023
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Sample size
Target
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Accrual to date
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Final
597
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Murdoch
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Recruitment hospital [2]
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Research Site - Port Macquarie
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Recruitment postcode(s) [1]
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6150 - Murdoch
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Recruitment postcode(s) [2]
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2444 - Port Macquarie
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Recruitment outside Australia
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Sakai-shi
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Japan
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State/province [96]
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Sapporo-shi
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Country [97]
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Japan
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State/province [97]
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Sendai-shi
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Country [98]
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Japan
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State/province [98]
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Shinjuku-ku
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Japan
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State/province [99]
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Sunto-gun
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Japan
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Takatsuki-shi
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Japan
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Wakayama-shi
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Japan
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Yokohama-shi
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Korea, Republic of
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State/province [103]
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Busan
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Korea, Republic of
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State/province [104]
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Cheongju-si
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Korea, Republic of
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State/province [105]
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Incheon
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Korea, Republic of
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State/province [106]
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Jeonnam
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Country [109]
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Netherlands
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State/province [109]
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Amsterdam
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Poland
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State/province [110]
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Lublin
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Country [111]
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Poland
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State/province [111]
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Poznan
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Poland
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State/province [112]
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Warszawa
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Country [113]
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Romania
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State/province [113]
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Alba Iulia
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Country [114]
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Romania
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State/province [114]
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Baia Mare
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Country [115]
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Romania
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State/province [115]
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Cluj Napoca
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Country [116]
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Romania
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State/province [116]
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Cluj-Napoca
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Country [117]
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Romania
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State/province [117]
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Onesti
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Country [118]
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Romania
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State/province [118]
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Oradea
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Country [119]
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Romania
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State/province [119]
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Timisoara
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Country [120]
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Russian Federation
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State/province [120]
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Arkhangelsk
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Russian Federation
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Omsk
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Russian Federation
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State/province [122]
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Saint Petersburg
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Country [123]
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Russian Federation
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State/province [123]
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St. Petersburg
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Country [124]
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Serbia
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State/province [124]
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Belgrade
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Serbia
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State/province [125]
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Belgrad
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Serbia
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State/province [126]
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Gornji Matejevac
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Country [127]
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Serbia
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State/province [127]
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Kragujevac
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Country [128]
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Serbia
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State/province [128]
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Sremska Kamenica
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Country [129]
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Singapore
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Singapore
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Spain
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State/province [130]
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A Coruña
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Spain
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Alicante
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Country [132]
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Spain
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Barcelona
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Country [133]
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Spain
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Girona
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Spain
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Jaén
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Country [135]
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Spain
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State/province [135]
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Lleida
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Country [136]
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Spain
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State/province [136]
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Madrid
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Country [137]
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Spain
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San Sebastian
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Country [138]
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Spain
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Sevilla
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Country [139]
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Spain
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State/province [139]
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Valencia
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Country [140]
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Taiwan
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State/province [140]
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Taichung
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Country [141]
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Taiwan
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State/province [141]
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Tainan
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Country [142]
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Taiwan
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State/province [142]
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Taipei City
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Taiwan
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Taipei
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Country [144]
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Thailand
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Bangkok
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Country [145]
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Thailand
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Muang
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Country [146]
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Thailand
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Phitsanulok
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Thailand
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Songkla
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Country [148]
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United Kingdom
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State/province [148]
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Birmingham
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Country [149]
0
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United Kingdom
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State/province [149]
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London
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Country [150]
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United Kingdom
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Southampton
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Country [151]
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United Kingdom
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Stevenage
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Country [152]
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United Kingdom
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State/province [152]
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0
Truro
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Country [153]
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United Kingdom
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State/province [153]
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy
and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1
positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab
(MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the
treatment of male and female patients with locally advanced or metastatic NSCLC (Stage
IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1
platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth
factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase
(ALK) rearrangements are not eligible for the study (prospective testing is not planned
within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor
(erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02352948
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Paul Stockman, MBChB, PhD
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Address
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AstraZeneca
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Fax
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02352948
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