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/show/NCT02576574




Registration number
NCT02576574
Ethics application status
Date submitted
13/10/2015
Date registered
15/10/2015
Date last updated
22/06/2020

Titles & IDs
Public title
Avelumab in First-line Non-Small Cell Lung Cancer (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+ Non-small Cell Lung Cancer
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 - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - 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

Experimental: Arm A: Avelumab -

Active Comparator: Arm B: Platinum-containing chemotherapy regimen - Platinum-containing chemotherapy regimen: Investigator's choice platinum containing chemotherapy regimen to be administered consisting of one of the following:
Non-squamous tumor histology
Pemetrexed (500 milligram per meter square [mg/m^2]) +cisplatin (75 mg/m^2) or Pemetrexed (500 mg/m^2) + carboplatin (AUC 6 mg/mL*min)
Squamous tumor histology
Paclitaxel (200 mg/m^2) +carboplatin (AUC 6 mg/mL*min)
Gemcitabine (1250 mg/m^2)+ cisplatin (75 mg/m^2)
Gemcitabine (1000 mg/m^2 )+carboplatin (AUC 5 mg/mL*min)

Experimental: Arm C: Avelumab -


Treatment: Drugs: Avelumab
Subjects will be administered with avelumab at a dose of 10 milligram per kilogram (mg/kg) 1-hour intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.

Treatment: Drugs: Pemetrexed
Pemetrexed 500 mg 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
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
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
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
Carboplatin 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
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
Subjects will be administered with avelumab at a dose of 10 milligram per kilogram (mg/kg) 1-hour intravenous (IV) infusion once a week for 12 weeks and then once every 2 weeks until disease progression or unacceptable toxicities.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) in Subjects With High PD-L1 + Tumor Expression Based on an Independent Review Committee (IRC) Assessment According to RECIST 1.1 - PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) as determined by the independent review committee or death due to any cause in the absence of documented PD, whichever occurs first.
Timepoint [1] 0 0
Time from date of randomization until PD or death, assessed up to 56 months
Primary outcome [2] 0 0
Overall Survival (OS) in Subjects With High PD-L1 + Tumor Expression - The OS is defined as the time from randomization to the date of death, regardless of the actual cause of the subjects' death.
Timepoint [2] 0 0
Time from date of randomization until death, assessed up to 56 months
Secondary outcome [1] 0 0
Best Overall Response (BOR) as Adjudicated by the IRC - BOR will be determined according to RECIST 1.1. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR.
Timepoint [1] 0 0
Time from date of randomization up to 56 months
Secondary outcome [2] 0 0
Duration of Response (DOR) According to RECIST 1.1 - DOR will be determined according to RECIST 1.1, defined for each subject with a confirmed response as the time from the date of the first assessment demonstrating a CR or PR to date of the first assessment demonstrating PD or death within 12 weeks after the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Timepoint [2] 0 0
Time from date of randomization up to 56 months
Secondary outcome [3] 0 0
European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire - The EQ-5D-5L Health Outcome Questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest is 1.00 (no problems in all 5 dimensions).
Timepoint [3] 0 0
Up to 56 months
Secondary outcome [4] 0 0
European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status - EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer subjects. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Timepoint [4] 0 0
Up to 56 months
Secondary outcome [5] 0 0
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) - EORTC QLQ-LC13 consists of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprise 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, and medicine for pain). Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).
Timepoint [5] 0 0
Up to 56 months
Secondary outcome [6] 0 0
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 - TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 30 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
Timepoint [6] 0 0
Up to 56 months
Secondary outcome [7] 0 0
Number of Subjects With Abnormalities in Safety Laboratory Tests as Graded by NCI-CTCAE (Version 4.03)
Timepoint [7] 0 0
Up to 56 months
Secondary outcome [8] 0 0
Number of Subjects With Abnormalities in Vital Signs, Physical Examination, and Eastern Cooperative Oncology Group (ECOG) PS.
Timepoint [8] 0 0
Up to 56 months
Secondary outcome [9] 0 0
Number of Subjects With Abnormalities in 12-lead ECG
Timepoint [9] 0 0
Up to 56 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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Vermont
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
Wyoming
Country [19] 0 0
Belgium
State/province [19] 0 0
Antwerpen
Country [20] 0 0
Belgium
State/province [20] 0 0
Brasschaat
Country [21] 0 0
Belgium
State/province [21] 0 0
Mons
Country [22] 0 0
Brazil
State/province [22] 0 0
Bahia
Country [23] 0 0
Brazil
State/province [23] 0 0
Ceará
Country [24] 0 0
Brazil
State/province [24] 0 0
Goiás
Country [25] 0 0
Brazil
State/province [25] 0 0
Paraná
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio Grande Do Sul
Country [27] 0 0
Brazil
State/province [27] 0 0
Santa Catarina
Country [28] 0 0
Brazil
State/province [28] 0 0
Sao Paulo
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio de Janeiro
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Ruse
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Sofia
Country [32] 0 0
Canada
State/province [32] 0 0
New Brunswick
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Chile
State/province [34] 0 0
Santiago
Country [35] 0 0
Chile
State/province [35] 0 0
Viña del Mar
Country [36] 0 0
China
State/province [36] 0 0
Beijing
Country [37] 0 0
China
State/province [37] 0 0
Guangdong
Country [38] 0 0
China
State/province [38] 0 0
Heilongjiang
Country [39] 0 0
China
State/province [39] 0 0
Liaoning
Country [40] 0 0
China
State/province [40] 0 0
Shandong
Country [41] 0 0
Colombia
State/province [41] 0 0
Bogotá
Country [42] 0 0
Colombia
State/province [42] 0 0
Floridablanca
Country [43] 0 0
Colombia
State/province [43] 0 0
Medellín
Country [44] 0 0
Colombia
State/province [44] 0 0
Monteria
Country [45] 0 0
Croatia
State/province [45] 0 0
Zagreb
Country [46] 0 0
Cyprus
State/province [46] 0 0
Nicosia
Country [47] 0 0
Czechia
State/province [47] 0 0
Liberec
Country [48] 0 0
Czechia
State/province [48] 0 0
Nova Ves pod Plesi
Country [49] 0 0
Czechia
State/province [49] 0 0
Olomouc
Country [50] 0 0
Czechia
State/province [50] 0 0
Ostrava - Vitkovice
Country [51] 0 0
Czechia
State/province [51] 0 0
Praha 4 - Krc
Country [52] 0 0
Czechia
State/province [52] 0 0
Usti nad Labem
Country [53] 0 0
Denmark
State/province [53] 0 0
Herning
Country [54] 0 0
Denmark
State/province [54] 0 0
Roskilde
Country [55] 0 0
Estonia
State/province [55] 0 0
Tallinn
Country [56] 0 0
France
State/province [56] 0 0
Alpes Maritimes
Country [57] 0 0
France
State/province [57] 0 0
Bas Rhin
Country [58] 0 0
France
State/province [58] 0 0
Bouches-du-Rhône
Country [59] 0 0
France
State/province [59] 0 0
Doubs
Country [60] 0 0
France
State/province [60] 0 0
Finistere
Country [61] 0 0
France
State/province [61] 0 0
Gironde
Country [62] 0 0
France
State/province [62] 0 0
Maine Et Loire
Country [63] 0 0
France
State/province [63] 0 0
Paris
Country [64] 0 0
France
State/province [64] 0 0
Pyrenees Atlantiques
Country [65] 0 0
France
State/province [65] 0 0
Rhone
Country [66] 0 0
France
State/province [66] 0 0
Sarthe
Country [67] 0 0
France
State/province [67] 0 0
Vaculuse
Country [68] 0 0
France
State/province [68] 0 0
Val De Marne
Country [69] 0 0
France
State/province [69] 0 0
Paris Cedex 10
Country [70] 0 0
Germany
State/province [70] 0 0
Baden Wuerttemberg
Country [71] 0 0
Germany
State/province [71] 0 0
Schleswig Holstein
Country [72] 0 0
Greece
State/province [72] 0 0
Athens
Country [73] 0 0
Greece
State/province [73] 0 0
Heraklion
Country [74] 0 0
Greece
State/province [74] 0 0
Patras
Country [75] 0 0
Greece
State/province [75] 0 0
Thessaloniki
Country [76] 0 0
Hungary
State/province [76] 0 0
Budapest
Country [77] 0 0
Hungary
State/province [77] 0 0
Deszk
Country [78] 0 0
Hungary
State/province [78] 0 0
Györ
Country [79] 0 0
Hungary
State/province [79] 0 0
Miskolc
Country [80] 0 0
Hungary
State/province [80] 0 0
Nyiregyhaza
Country [81] 0 0
Hungary
State/province [81] 0 0
Szekszard
Country [82] 0 0
Hungary
State/province [82] 0 0
Torokbalint
Country [83] 0 0
Hungary
State/province [83] 0 0
Zalaegerszeg
Country [84] 0 0
Ireland
State/province [84] 0 0
Cork
Country [85] 0 0
Israel
State/province [85] 0 0
Beer Sheva
Country [86] 0 0
Israel
State/province [86] 0 0
Haifa
Country [87] 0 0
Israel
State/province [87] 0 0
Jerusalem
Country [88] 0 0
Israel
State/province [88] 0 0
Kfar-Saba
Country [89] 0 0
Israel
State/province [89] 0 0
Petach Tikva
Country [90] 0 0
Israel
State/province [90] 0 0
Ramat Gan
Country [91] 0 0
Israel
State/province [91] 0 0
Rechovot
Country [92] 0 0
Israel
State/province [92] 0 0
Rishon Lezion
Country [93] 0 0
Israel
State/province [93] 0 0
Tel Aviv
Country [94] 0 0
Italy
State/province [94] 0 0
Verona
Country [95] 0 0
Italy
State/province [95] 0 0
Brescia
Country [96] 0 0
Italy
State/province [96] 0 0
Catania
Country [97] 0 0
Italy
State/province [97] 0 0
Genova
Country [98] 0 0
Italy
State/province [98] 0 0
Napoli
Country [99] 0 0
Italy
State/province [99] 0 0
Parma
Country [100] 0 0
Italy
State/province [100] 0 0
Pisa
Country [101] 0 0
Japan
State/province [101] 0 0
Chiba-Ken
Country [102] 0 0
Japan
State/province [102] 0 0
Fukuoka-Ken
Country [103] 0 0
Japan
State/province [103] 0 0
Hokkaido
Country [104] 0 0
Japan
State/province [104] 0 0
Hyogo-Ken
Country [105] 0 0
Japan
State/province [105] 0 0
Kanagawa-Ken
Country [106] 0 0
Japan
State/province [106] 0 0
Osaka-Fu
Country [107] 0 0
Japan
State/province [107] 0 0
Tokyo-To
Country [108] 0 0
Japan
State/province [108] 0 0
Toyama-Ken
Country [109] 0 0
Japan
State/province [109] 0 0
Kobe-shi
Country [110] 0 0
Korea, Republic of
State/province [110] 0 0
Chungcheongbuk-do
Country [111] 0 0
Korea, Republic of
State/province [111] 0 0
Gangwon-do
Country [112] 0 0
Korea, Republic of
State/province [112] 0 0
Gyeonggi-do
Country [113] 0 0
Korea, Republic of
State/province [113] 0 0
Daegu
Country [114] 0 0
Korea, Republic of
State/province [114] 0 0
Incheon
Country [115] 0 0
Korea, Republic of
State/province [115] 0 0
Seoul
Country [116] 0 0
Korea, Republic of
State/province [116] 0 0
Ulsan
Country [117] 0 0
Lebanon
State/province [117] 0 0
Beirut
Country [118] 0 0
Lebanon
State/province [118] 0 0
Saida
Country [119] 0 0
Lithuania
State/province [119] 0 0
Kaunas
Country [120] 0 0
Netherlands
State/province [120] 0 0
Groningen
Country [121] 0 0
Netherlands
State/province [121] 0 0
Hoorn
Country [122] 0 0
Netherlands
State/province [122] 0 0
Tilburg
Country [123] 0 0
New Zealand
State/province [123] 0 0
Auckland
Country [124] 0 0
New Zealand
State/province [124] 0 0
Dunedin
Country [125] 0 0
New Zealand
State/province [125] 0 0
Hamilton
Country [126] 0 0
New Zealand
State/province [126] 0 0
Palmerston North
Country [127] 0 0
New Zealand
State/province [127] 0 0
Tauranga
Country [128] 0 0
New Zealand
State/province [128] 0 0
Wellington
Country [129] 0 0
Peru
State/province [129] 0 0
Lima
Country [130] 0 0
Poland
State/province [130] 0 0
Lodz
Country [131] 0 0
Poland
State/province [131] 0 0
Lublin
Country [132] 0 0
Poland
State/province [132] 0 0
Mrozy
Country [133] 0 0
Poland
State/province [133] 0 0
Olsztyn
Country [134] 0 0
Poland
State/province [134] 0 0
Otwock
Country [135] 0 0
Poland
State/province [135] 0 0
Poznan
Country [136] 0 0
Poland
State/province [136] 0 0
Szklarska Poreba
Country [137] 0 0
Poland
State/province [137] 0 0
Warszawa
Country [138] 0 0
Poland
State/province [138] 0 0
Wieliszew
Country [139] 0 0
Portugal
State/province [139] 0 0
Almada
Country [140] 0 0
Portugal
State/province [140] 0 0
Amadora-Lisbon
Country [141] 0 0
Portugal
State/province [141] 0 0
Coimbra
Country [142] 0 0
Portugal
State/province [142] 0 0
Lisboa
Country [143] 0 0
Portugal
State/province [143] 0 0
Porto
Country [144] 0 0
Portugal
State/province [144] 0 0
Santa Maria da Feira
Country [145] 0 0
Portugal
State/province [145] 0 0
Vila Nova de Gaia
Country [146] 0 0
Romania
State/province [146] 0 0
Baia Mare
Country [147] 0 0
Romania
State/province [147] 0 0
Brasov
Country [148] 0 0
Romania
State/province [148] 0 0
Bucuresti
Country [149] 0 0
Romania
State/province [149] 0 0
Cluj Napoca
Country [150] 0 0
Romania
State/province [150] 0 0
Cluj-Napoca
Country [151] 0 0
Romania
State/province [151] 0 0
Comuna Floresti
Country [152] 0 0
Romania
State/province [152] 0 0
Constanta
Country [153] 0 0
Romania
State/province [153] 0 0
Craiova
Country [154] 0 0
Romania
State/province [154] 0 0
Iasi
Country [155] 0 0
Romania
State/province [155] 0 0
Oradea
Country [156] 0 0
Romania
State/province [156] 0 0
Suceava
Country [157] 0 0
Romania
State/province [157] 0 0
Timisoara
Country [158] 0 0
Russian Federation
State/province [158] 0 0
Arkhangelsk
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Chelyabinsk
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Irkutsk
Country [161] 0 0
Russian Federation
State/province [161] 0 0
Ivanovo
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Kaluga
Country [163] 0 0
Russian Federation
State/province [163] 0 0
Kazan
Country [164] 0 0
Russian Federation
State/province [164] 0 0
Kemerovo
Country [165] 0 0
Russian Federation
State/province [165] 0 0
Krasnoyarsk
Country [166] 0 0
Russian Federation
State/province [166] 0 0
Kursk
Country [167] 0 0
Russian Federation
State/province [167] 0 0
Moscow
Country [168] 0 0
Russian Federation
State/province [168] 0 0
Murmansk
Country [169] 0 0
Russian Federation
State/province [169] 0 0
Novosibirsk
Country [170] 0 0
Russian Federation
State/province [170] 0 0
Pyatigorsk
Country [171] 0 0
Russian Federation
State/province [171] 0 0
Saint-Petersburg
Country [172] 0 0
Russian Federation
State/province [172] 0 0
Samara
Country [173] 0 0
Russian Federation
State/province [173] 0 0
Sochi
Country [174] 0 0
Russian Federation
State/province [174] 0 0
St. Petersburg
Country [175] 0 0
Russian Federation
State/province [175] 0 0
Tomsk
Country [176] 0 0
Russian Federation
State/province [176] 0 0
Tyumen
Country [177] 0 0
Russian Federation
State/province [177] 0 0
Yaroslavl
Country [178] 0 0
Serbia
State/province [178] 0 0
Belgrade
Country [179] 0 0
Serbia
State/province [179] 0 0
Gornji Matejevac
Country [180] 0 0
Serbia
State/province [180] 0 0
Kragujevac
Country [181] 0 0
Serbia
State/province [181] 0 0
Sremska Kamenica
Country [182] 0 0
Singapore
State/province [182] 0 0
Singapore
Country [183] 0 0
Slovakia
State/province [183] 0 0
Bardejov
Country [184] 0 0
Slovakia
State/province [184] 0 0
Bratislava
Country [185] 0 0
South Africa
State/province [185] 0 0
Gauteng
Country [186] 0 0
South Africa
State/province [186] 0 0
Western Cape
Country [187] 0 0
Spain
State/province [187] 0 0
Barcelona
Country [188] 0 0
Spain
State/province [188] 0 0
Guipuzcoa
Country [189] 0 0
Spain
State/province [189] 0 0
La Coruña
Country [190] 0 0
Spain
State/province [190] 0 0
Pontevedra
Country [191] 0 0
Spain
State/province [191] 0 0
Girona
Country [192] 0 0
Spain
State/province [192] 0 0
Madrid
Country [193] 0 0
Spain
State/province [193] 0 0
Málaga
Country [194] 0 0
Spain
State/province [194] 0 0
Sevilla
Country [195] 0 0
Spain
State/province [195] 0 0
Vitoria
Country [196] 0 0
Taiwan
State/province [196] 0 0
Kaohsiung
Country [197] 0 0
Taiwan
State/province [197] 0 0
Taichung
Country [198] 0 0
Taiwan
State/province [198] 0 0
Taipei
Country [199] 0 0
Taiwan
State/province [199] 0 0
Taoyuan County
Country [200] 0 0
Thailand
State/province [200] 0 0
Bangkok
Country [201] 0 0
Thailand
State/province [201] 0 0
Chiang Mai
Country [202] 0 0
Thailand
State/province [202] 0 0
Khon Kaen
Country [203] 0 0
Thailand
State/province [203] 0 0
Phitsanulok
Country [204] 0 0
Thailand
State/province [204] 0 0
Songkhla
Country [205] 0 0
Turkey
State/province [205] 0 0
Adana
Country [206] 0 0
Turkey
State/province [206] 0 0
Ankara
Country [207] 0 0
Turkey
State/province [207] 0 0
Antalya
Country [208] 0 0
Turkey
State/province [208] 0 0
Istanbul
Country [209] 0 0
Turkey
State/province [209] 0 0
Izmir
Country [210] 0 0
Turkey
State/province [210] 0 0
Malatya
Country [211] 0 0
Turkey
State/province [211] 0 0
Mersin
Country [212] 0 0
Turkey
State/province [212] 0 0
Sakarya
Country [213] 0 0
Turkey
State/province [213] 0 0
Tekirdag
Country [214] 0 0
Ukraine
State/province [214] 0 0
Chernivtsi
Country [215] 0 0
Ukraine
State/province [215] 0 0
Dnipro
Country [216] 0 0
Ukraine
State/province [216] 0 0
Ivano-Frankivsk
Country [217] 0 0
Ukraine
State/province [217] 0 0
Kharkiv
Country [218] 0 0
Ukraine
State/province [218] 0 0
Kherson
Country [219] 0 0
Ukraine
State/province [219] 0 0
Kropyvnytskyi
Country [220] 0 0
Ukraine
State/province [220] 0 0
Kryvyi Rih, Dnipropetrovsk Region
Country [221] 0 0
Ukraine
State/province [221] 0 0
Kyiv
Country [222] 0 0
Ukraine
State/province [222] 0 0
Lutsk
Country [223] 0 0
Ukraine
State/province [223] 0 0
Lviv
Country [224] 0 0
Ukraine
State/province [224] 0 0
Odesa
Country [225] 0 0
Ukraine
State/province [225] 0 0
Sumy
Country [226] 0 0
Ukraine
State/province [226] 0 0
Uzhgorod
Country [227] 0 0
Ukraine
State/province [227] 0 0
Vinnytsia
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Essex
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Gloucestershire
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Greater London
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Hertfordshire
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Merseyside
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Staffordshire

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 is 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) subjects with
Programmed death ligand 1+ (PD-L1+) tumors
Trial website
https://clinicaltrials.gov/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
Other publications