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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/NCT02576574




Registration number
NCT02576574
Ethics application status
Date submitted
13/10/2015
Date registered
15/10/2015
Date last updated
20/03/2024

Titles & IDs
Public title
Avelumab in First-line NSCLC (JAVELIN Lung 100)
Scientific title
A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC
Secondary ID [1] 0 0
2015-001537-24
Secondary ID [2] 0 0
EMR 100070-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First Line Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avelumab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Avelumab Weekly

Experimental: Avelumab Biweekly -

Experimental: Avelumab Weekly -

Active Comparator: Chemotherapy -


Treatment: Drugs: Avelumab
Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.

Treatment: Drugs: Pemetrexed
Participants received Pemetrexed 500 milligrams per square meter (mg/m^2) by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Treatment: Drugs: Paclitaxel
Participants received Paclitaxel 200 mg/m^2 by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Treatment: Drugs: Gemcitabine
Participants received Gemcitabine 1250 mg/m^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles when combined with cisplatin of IV injection until disease progression or unacceptable toxicities.

Treatment: Drugs: Gemcitabine
Participants received Gemcitabine 1000 mg/m^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with carboplatin until disease progression or unacceptable toxicities.

Treatment: Drugs: Carboplatin
Participants received Carboplatin area under concentration curve (AUC) 5 mg/mL*min in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with gemcitabine until disease progression or unacceptable toxicities.

Treatment: Drugs: Cisplatin
Participants received Cisplatin 75 mg/m^2 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.

Treatment: Drugs: Carboplatin
Carboplatin AUC 6 mg/mL*min by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with pemetrexed, or paclitaxel until disease progression or unacceptable toxicities.

Treatment: Drugs: Avelumab Weekly
Participants received Avelumab at a dose of 10 mg/kg as a 1-hour (-10/+20 minutes) IV infusion every week for 12 consecutive weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)
Timepoint [1] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Primary outcome [2] 0 0
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS)
Timepoint [2] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Primary outcome [3] 0 0
Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)
Timepoint [3] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Primary outcome [4] 0 0
Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
Timepoint [4] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [1] 0 0
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)
Timepoint [1] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [2] 0 0
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
Timepoint [2] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [3] 0 0
Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)
Timepoint [3] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [4] 0 0
Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
Timepoint [4] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [5] 0 0
Overall Survival (OS) in Full Analysis Set (FAS)
Timepoint [5] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [6] 0 0
Overall Survival (OS) in Modified Full Analysis Set (mFAS)
Timepoint [6] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [7] 0 0
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Full Analysis Set
Timepoint [7] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [8] 0 0
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High PD-L1+ Modified Full Analysis Set
Timepoint [8] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [9] 0 0
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Full Analysis Set
Timepoint [9] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [10] 0 0
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in Moderate and High PD-L1+ Modified Full Analysis Set
Timepoint [10] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [11] 0 0
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS)
Timepoint [11] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [12] 0 0
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
Timepoint [12] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [13] 0 0
Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High PD-L1+ Health-related Quality of Life (HRQoL) Analysis Set at End of Treatment
Timepoint [13] 0 0
Baseline, End of treatment (up to Week 283.9)
Secondary outcome [14] 0 0
Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
Timepoint [14] 0 0
Baseline, End of treatment (Week 283.9)
Secondary outcome [15] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set
Timepoint [15] 0 0
Baseline, End of treatment (up to Week 283.9)
Secondary outcome [16] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
Timepoint [16] 0 0
Baseline, End of treatment (Week 283.9)
Secondary outcome [17] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set
Timepoint [17] 0 0
Baseline, End of treatment (up to Week 283.9)
Secondary outcome [18] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
Timepoint [18] 0 0
Baseline, End of treatment (up to Week 283.9)
Secondary outcome [19] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and AEs of Special Interest (AESIs)
Timepoint [19] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [20] 0 0
Number of Participants With Shift From Baseline to Greater Than or Equal to (>=) Grade 3 in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03
Timepoint [20] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [21] 0 0
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Body Temperature Increase
Timepoint [21] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [22] 0 0
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Weight Increase/Decrease
Timepoint [22] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [23] 0 0
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Heart Rate Increase/Decrease
Timepoint [23] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [24] 0 0
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Systolic Blood Pressure Increase/Decrease and Maximal Diastolic Blood Pressure Increase/Decrease
Timepoint [24] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [25] 0 0
Number of Participants With Maximal On-Treatment Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease
Timepoint [25] 0 0
Time from date of randomization up to data cutoff (assessed up to 71.5 months)
Secondary outcome [26] 0 0
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Electrocardiogram (ECG) Parameters
Timepoint [26] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [27] 0 0
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score
Timepoint [27] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)
Secondary outcome [28] 0 0
Number of Participants With At Least One Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab
Timepoint [28] 0 0
Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months)

Eligibility
Key inclusion criteria
- Male or female subjects aged greater than or equal to (>=) 18 years

- With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at
trial entry

- At least 1 measurable tumor lesion

- With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung
cancer (NSCLC)

- With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE)
tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6
months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1
week, and suitable for PD-L1 expression assessment

- Subjects must not have received any treatment for systemic lung cancer, and have an
estimated life expectancy of more than 12 weeks

- Other protocol defined criteria could apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects whose disease harbors a EGFR mutation, or anaplastic lymphoma kinase (ALK)
rearrangement are not eligible.

- Other exclusion criteria include prior therapy with any antibody or drug targeting T
cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive
agents

- Known severe hypersensitivity reactions to monoclonal antibodies (Grade >= 3 NCI CTCAE
v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features
of partially controlled asthma), and persisting toxicity related to prior therapy of
Grade > 1 NCI-CTCAE v 4.03.

- Subjects with brain metastases are excluded, except those meeting the following
criteria: brain metastases that have been treated locally and are clinically stable
for at least 2 weeks prior to randomization, subjects must be either off steroids or
on a stable or decreasing dose of <= 10 mg daily prednisone (or equivalent), and do
not have ongoing neurological symptoms that are related to the brain localization of
the disease.

- Other protocol defined criteria could apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/01/2024
Sample size
Target
Accrual to date
Final
1214
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Albury Wodonga Regional Cancer Centre - Albury
Recruitment hospital [2] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [3] 0 0
St George Private Hospital - Kogarah
Recruitment hospital [4] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [5] 0 0
Orange Health Service - Orange
Recruitment hospital [6] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [7] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [8] 0 0
Gallipoli Medical Research Foundation Ltd - Greenslopes
Recruitment hospital [9] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [10] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [11] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [12] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [13] 0 0
South West Healthcare - Warrnambool
Recruitment hospital [14] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
2800 - Orange
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2298 - Waratah
Recruitment postcode(s) [8] 0 0
4120 - Greenslopes
Recruitment postcode(s) [9] 0 0
4215 - Southport
Recruitment postcode(s) [10] 0 0
5011 - Woodville South
Recruitment postcode(s) [11] 0 0
3350 - Ballarat
Recruitment postcode(s) [12] 0 0
3550 - Bendigo
Recruitment postcode(s) [13] 0 0
3280 - Warrnambool
Recruitment postcode(s) [14] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
Florida
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United States of America
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Georgia
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United States of America
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Louisiana
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United States of America
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Michigan
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Montana
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Nevada
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New Mexico
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Vermont
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Washington
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Wyoming
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Belgium
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Antwerpen
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Brasschaat
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Belgium
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Mons
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Bahia
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Ceará
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Goiás
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Paraná
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Rio Grande Do Sul
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Santa Catarina
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Rio de Janeiro
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Ruse
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Sofia
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China
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Sarthe
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Schleswig Holstein
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Greece
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Athens
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Greece
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Heraklion
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Patras
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Deszk
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Györ
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Miskolc
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Hungary
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Nyiregyhaza
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Szekszard
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Torokbalint
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Zalaegerszeg
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Ireland
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Cork
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar-Saba
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Rechovot
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Israel
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Rishon Lezion
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Israel
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Tel Aviv
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Italy
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Verona
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Italy
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Brescia
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Italy
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Catania
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Italy
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Genova
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Italy
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Napoli
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Italy
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Parma
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Italy
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Pisa
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Japan
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Chiba-Ken
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Fukuoka-Ken
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Japan
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Hokkaido
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Japan
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Hyogo-Ken
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Japan
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Kanagawa-Ken
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Japan
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Osaka-Fu
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Japan
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Tokyo-To
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Toyama-Ken
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Kobe-shi
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Korea, Republic of
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EMD Serono Research & Development Institute, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS)
or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an
Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants
with Programmed death ligand 1+ (PD-L1+) tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02576574
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02576574