Please note the ANZCTR will be unattended from Friday 24 December 2021 for the holidays. The Registry will re-open on Monday 17 January 2022. Submissions and updates will not be processed during that time.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

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/NCT02395172




Registration number
NCT02395172
Ethics application status
Date submitted
27/02/2015
Date registered
20/03/2015
Date last updated
3/08/2020

Titles & IDs
Public title
Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)
Scientific title
A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet
Secondary ID [1] 0 0
2014-005060-15
Secondary ID [2] 0 0
100070-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 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 - Docetaxel

Experimental: Avelumab -

Active Comparator: Docetaxel -


Treatment: Drugs: Avelumab
Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.

Treatment: Drugs: Docetaxel
Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.

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

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS) - The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.
Timepoint [1] 0 0
Time from date of randomization up to 1420 days
Secondary outcome [1] 0 0
Overall Survival (OS) Time in Full Analysis Set Population - The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.
Timepoint [1] 0 0
Time from date of randomization up to 1420 days
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population - PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.
Timepoint [2] 0 0
Time from date of randomization up to 907 days
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) Time in Full Analysis Set Population - PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.
Timepoint [3] 0 0
Time from date of randomization up to 907 days
Secondary outcome [4] 0 0
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population - Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). 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. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Timepoint [4] 0 0
Time from date of randomization up to 907 days
Secondary outcome [5] 0 0
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population - Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). 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. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Timepoint [5] 0 0
Time from date of randomization up to 907 days
Secondary outcome [6] 0 0
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population - Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. 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.
Timepoint [6] 0 0
Time from date of randomization up to 907 days
Secondary outcome [7] 0 0
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population - Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. 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.
Timepoint [7] 0 0
Time from date of randomization up to 907 days
Secondary outcome [8] 0 0
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT) - The EQ-5D-5L health outcome questionnaire was a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defined health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items were combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score was -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 was 1.00 (no problems in all 5 dimensions).
Timepoint [8] 0 0
Baseline, End of treatment visit (up to Week 124)
Secondary outcome [9] 0 0
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT) - EQ-5D-5L was comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.
Timepoint [9] 0 0
Baseline, End of treatment visit (up to Week 124)
Secondary outcome [10] 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) - EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted 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 ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Timepoint [10] 0 0
Baseline, End of treatment visit (up to Week 124)
Secondary outcome [11] 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) - EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. 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 [11] 0 0
Baseline, End of treatment visit (up to Week 124)
Secondary outcome [12] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death - An Adverse event (AE) was defined as any unfavorable and unintended sign (including clinically significant abnormal laboratory, vital signs and 12-lead Electrocardiogram findings), symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.
Timepoint [12] 0 0
Time from date of randomization up to 1420 days
Secondary outcome [13] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity - Treatment Emergent Adverse Events were graded as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03). Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL), Grade 4 refers to Life-threatening consequences; where urgent intervention indicated, Grade 5 refers to the death related to adverse event.
Timepoint [13] 0 0
Time from date of randomization up to 1420 days
Secondary outcome [14] 0 0
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score - ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. The participants with missing worst post baseline score were also reported. ECOG performance status was reported in terms of number of participants with Baseline value vs. worst post-baseline value (i.e. highest score) combination.
Timepoint [14] 0 0
Time from date of randomization up to 1420 days
Secondary outcome [15] 0 0
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab - Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.
Timepoint [15] 0 0
Time from date of randomization up to 1420 days

Eligibility
Key inclusion criteria
Inclusion Criteria

- Signed written informed consent before any trial related procedure

- Male or female participants aged greater than or equal to (>=) 18 years

- Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 7
unstained tumor slides suitable for PD-L1 expression assessment

- Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central
laboratory

- Participants with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have
experienced disease progression

- Participants must have progressed after an acceptable therapy defined as follows:

1. Participants must have progressed during or after a minimum of 2 cycles of 1
course of a platinum based combination therapy administered for the treatment of
a metastatic disease. A history of continuation (use of a non platinum agent from
initial combination) or switch (use of a different agent) maintenance therapy is
permitted provided there was no progression after the initial combination. A
switch of agents during treatment for the management of toxicities is also
permitted provided there was no progression after the initial combination OR

2. Participants must have progressed within 6 months of completion of a
platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant
chemoradiation regimen for locally advanced disease

- Participants with non-squamous cell NSCLC of unknown epidermal growth factor receptor
(EGFR) mutation status will require testing (local laboratory, or central laboratory
if local testing is not available). Participants with a tumor that harbors an
activating EGFR mutation will not be eligible

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

- Estimated life expectancy of more than 12 weeks

- Adequate hematological function defined by White Blood Cell (WBC) count >= 2.5 ×
10^9/L with absolute neutrophil count (ANC) >= 1.5 × 10^9/L, lymphocyte count >=0.5 ×
10^9/L, platelet count >= 100 × 10^9/L, and hemoglobin >= 9 gram per deciliter (g/dL)
(may have been transfused)

- Adequate hepatic function defined by a total bilirubin level less than or equal to
(<=) 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST)
and alanine aminotransferase (ALT) levels <= 2.5 × ULN for all participants

- Adequate renal function defined by an estimated creatinine clearance > 30 milliliter
per minute (mL/min) according to the Cockcroft-Gault formula (or local institutional
standard method).

Other protocol defined inclusion criteria could apply
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

- In the United States only, participants with a squamous cell histology will be
excluded

- Systemic anticancer therapy administered after disease progression during or following
a platinum based combination

- Participants with non-squamous cell NSCLC whose disease harbors EGFR mutation(s)
and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this
trial. Participants of unknown ALK and/or EGFR mutation status will require testing at
screening (local laboratory, or central laboratory if local testing is not available)

- Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune
checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4).

- Concurrent anticancer treatment

- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of
randomization and/or if the participant has not fully recovered from the surgery
within 4 weeks of randomization

- Participants receiving immunosuppressive agents (such as steroids) for any reason
should be tapered off these drugs before initiation of the trial treatment.

- All participants with brain metastases, except those meeting the following criteria:

1. Brain metastases have been treated locally, and

2. No ongoing neurological symptoms that are related to the brain localization of
the disease

- Active autoimmune disease that might deteriorate when receiving an immunostimulatory
agent:

1. Participants with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid
disease not requiring immunosuppressive treatment are eligible

2. Participants requiring hormone replacement with corticosteroids are eligible if
the steroids are administered only for the purpose of hormonal replacement and at
doses less than or equal to (<=)10 milligram (mg) or equivalent prednisone per
day

3. Administration of steroids through a route known to result in a minimal systemic
exposure are acceptable

- Previous or ongoing administration of systemic steroids for the management of an acute
allergic phenomenon is acceptable as long as it is anticipated that the administration
of steroids will be completed in 14 days, or that the daily dose after 14 days will be
<=10 mg per day of equivalent prednisone

Other protocol defined exclusion 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
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)
Recruitment hospital [1] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [4] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [5] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [6] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
St John of God Hospital - Subiaco
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
4120 - Greenslopes
Recruitment postcode(s) [6] 0 0
2480 - Lismore
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6008 - Subiaco
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
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
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
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
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Argentina
State/province [16] 0 0
Bahia Blanca
Country [17] 0 0
Argentina
State/province [17] 0 0
Barrio General Paz
Country [18] 0 0
Argentina
State/province [18] 0 0
Berazategui
Country [19] 0 0
Argentina
State/province [19] 0 0
Ciudad Autonoma Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Cordoba
Country [21] 0 0
Argentina
State/province [21] 0 0
La Rioja
Country [22] 0 0
Argentina
State/province [22] 0 0
Parana
Country [23] 0 0
Argentina
State/province [23] 0 0
Pilar
Country [24] 0 0
Argentina
State/province [24] 0 0
Rosario
Country [25] 0 0
Argentina
State/province [25] 0 0
San Miguel de Tucuman
Country [26] 0 0
Belgium
State/province [26] 0 0
Edegem
Country [27] 0 0
Belgium
State/province [27] 0 0
Gilly
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Belgium
State/province [29] 0 0
Libramont
Country [30] 0 0
Belgium
State/province [30] 0 0
Liège
Country [31] 0 0
Belgium
State/province [31] 0 0
Roeselare
Country [32] 0 0
Brazil
State/province [32] 0 0
Belo Horizonte
Country [33] 0 0
Brazil
State/province [33] 0 0
Florianópolis
Country [34] 0 0
Brazil
State/province [34] 0 0
Ijuí
Country [35] 0 0
Brazil
State/province [35] 0 0
Itajaí
Country [36] 0 0
Brazil
State/province [36] 0 0
Juiz de Fora
Country [37] 0 0
Brazil
State/province [37] 0 0
Lajeado
Country [38] 0 0
Brazil
State/province [38] 0 0
Natal
Country [39] 0 0
Brazil
State/province [39] 0 0
Novo Hamburgo
Country [40] 0 0
Brazil
State/province [40] 0 0
Passo Fundo
Country [41] 0 0
Brazil
State/province [41] 0 0
Porto Alegre
Country [42] 0 0
Brazil
State/province [42] 0 0
Rio de Janeiro
Country [43] 0 0
Brazil
State/province [43] 0 0
Santo André
Country [44] 0 0
Brazil
State/province [44] 0 0
Sorocaba
Country [45] 0 0
Brazil
State/province [45] 0 0
São José do Rio Preto
Country [46] 0 0
Brazil
State/province [46] 0 0
São Paulo
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Pleven
Country [48] 0 0
Bulgaria
State/province [48] 0 0
Plovdiv
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Sofia
Country [50] 0 0
Bulgaria
State/province [50] 0 0
Varna
Country [51] 0 0
Chile
State/province [51] 0 0
Santiago
Country [52] 0 0
Chile
State/province [52] 0 0
Temuco
Country [53] 0 0
Chile
State/province [53] 0 0
Viña del Mar
Country [54] 0 0
Colombia
State/province [54] 0 0
Bogota
Country [55] 0 0
Colombia
State/province [55] 0 0
Bogotá
Country [56] 0 0
Colombia
State/province [56] 0 0
Cali
Country [57] 0 0
Colombia
State/province [57] 0 0
Medellin
Country [58] 0 0
Colombia
State/province [58] 0 0
Medellín
Country [59] 0 0
Colombia
State/province [59] 0 0
Monteria
Country [60] 0 0
Croatia
State/province [60] 0 0
Dubrovnik
Country [61] 0 0
Croatia
State/province [61] 0 0
Zadar
Country [62] 0 0
Croatia
State/province [62] 0 0
Zagreb
Country [63] 0 0
Czechia
State/province [63] 0 0
Brno
Country [64] 0 0
Czechia
State/province [64] 0 0
Novy Jicin
Country [65] 0 0
Czechia
State/province [65] 0 0
Pardubice
Country [66] 0 0
Czechia
State/province [66] 0 0
Praha 2
Country [67] 0 0
Czechia
State/province [67] 0 0
Praha 4
Country [68] 0 0
Denmark
State/province [68] 0 0
Herlev
Country [69] 0 0
Denmark
State/province [69] 0 0
Odense C
Country [70] 0 0
France
State/province [70] 0 0
Angers Cedex 9
Country [71] 0 0
France
State/province [71] 0 0
Besancon Cedex
Country [72] 0 0
France
State/province [72] 0 0
Le Mans Cedex 02
Country [73] 0 0
France
State/province [73] 0 0
Marseille cedex 20
Country [74] 0 0
France
State/province [74] 0 0
Nantes
Country [75] 0 0
France
State/province [75] 0 0
Nice cedex 02
Country [76] 0 0
France
State/province [76] 0 0
Pessac
Country [77] 0 0
France
State/province [77] 0 0
Poitiers
Country [78] 0 0
France
State/province [78] 0 0
Saint Herblain
Country [79] 0 0
France
State/province [79] 0 0
Strasbourg
Country [80] 0 0
France
State/province [80] 0 0
Toulouse
Country [81] 0 0
Hungary
State/province [81] 0 0
Budapest
Country [82] 0 0
Hungary
State/province [82] 0 0
Györ
Country [83] 0 0
Hungary
State/province [83] 0 0
Miskolc
Country [84] 0 0
Hungary
State/province [84] 0 0
Torokbalint
Country [85] 0 0
Israel
State/province [85] 0 0
Beer Sheva
Country [86] 0 0
Israel
State/province [86] 0 0
Beer Yaakov
Country [87] 0 0
Israel
State/province [87] 0 0
Haifa
Country [88] 0 0
Israel
State/province [88] 0 0
Jerusalem
Country [89] 0 0
Israel
State/province [89] 0 0
Kfar-Saba
Country [90] 0 0
Israel
State/province [90] 0 0
Petach Tikva
Country [91] 0 0
Israel
State/province [91] 0 0
Ramat-Gan
Country [92] 0 0
Israel
State/province [92] 0 0
Tel Aviv
Country [93] 0 0
Italy
State/province [93] 0 0
Cremona
Country [94] 0 0
Italy
State/province [94] 0 0
Legnago (VR)
Country [95] 0 0
Italy
State/province [95] 0 0
Lido di Camaiore
Country [96] 0 0
Italy
State/province [96] 0 0
Milano
Country [97] 0 0
Italy
State/province [97] 0 0
Napoli
Country [98] 0 0
Italy
State/province [98] 0 0
Pisa
Country [99] 0 0
Italy
State/province [99] 0 0
Roma
Country [100] 0 0
Italy
State/province [100] 0 0
Siena
Country [101] 0 0
Italy
State/province [101] 0 0
Treviglio
Country [102] 0 0
Japan
State/province [102] 0 0
Chuo-ku
Country [103] 0 0
Japan
State/province [103] 0 0
Fukuoka-shi
Country [104] 0 0
Japan
State/province [104] 0 0
Habikino-shi
Country [105] 0 0
Japan
State/province [105] 0 0
Hiroshima-shi
Country [106] 0 0
Japan
State/province [106] 0 0
Kashiwa-shi
Country [107] 0 0
Japan
State/province [107] 0 0
Kitaadachi-gun
Country [108] 0 0
Japan
State/province [108] 0 0
Kobe-shi
Country [109] 0 0
Japan
State/province [109] 0 0
Koto-ku
Country [110] 0 0
Japan
State/province [110] 0 0
Kurume-shi
Country [111] 0 0
Japan
State/province [111] 0 0
Natori-shi
Country [112] 0 0
Japan
State/province [112] 0 0
Okazaki-shi
Country [113] 0 0
Japan
State/province [113] 0 0
Osaka-shi
Country [114] 0 0
Japan
State/province [114] 0 0
Osakasayama-shi
Country [115] 0 0
Japan
State/province [115] 0 0
Sagamihara-shi
Country [116] 0 0
Japan
State/province [116] 0 0
Sapporo-shi
Country [117] 0 0
Japan
State/province [117] 0 0
Shinjuku-ku
Country [118] 0 0
Japan
State/province [118] 0 0
Toyama-shi
Country [119] 0 0
Japan
State/province [119] 0 0
Wakayama-shi
Country [120] 0 0
Japan
State/province [120] 0 0
Yokohama-shi
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Cheongju-si
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Hwasun-gun
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Incheon
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Seongnam-si
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Seoul
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Suwon-si
Country [127] 0 0
Mexico
State/province [127] 0 0
Cuautitlan Izcalli
Country [128] 0 0
Mexico
State/province [128] 0 0
Durango
Country [129] 0 0
Mexico
State/province [129] 0 0
Leon
Country [130] 0 0
Mexico
State/province [130] 0 0
Mexico
Country [131] 0 0
Mexico
State/province [131] 0 0
Monterrey
Country [132] 0 0
Mexico
State/province [132] 0 0
Morelia
Country [133] 0 0
Mexico
State/province [133] 0 0
Oaxaca
Country [134] 0 0
Mexico
State/province [134] 0 0
Toluca
Country [135] 0 0
Peru
State/province [135] 0 0
Arequipa
Country [136] 0 0
Peru
State/province [136] 0 0
Chiclayo
Country [137] 0 0
Peru
State/province [137] 0 0
Cusco
Country [138] 0 0
Peru
State/province [138] 0 0
Lima
Country [139] 0 0
Poland
State/province [139] 0 0
Brzozow
Country [140] 0 0
Poland
State/province [140] 0 0
Jelenia Gora
Country [141] 0 0
Poland
State/province [141] 0 0
Katowice
Country [142] 0 0
Poland
State/province [142] 0 0
Lodz
Country [143] 0 0
Poland
State/province [143] 0 0
Lublin
Country [144] 0 0
Poland
State/province [144] 0 0
Mrozy
Country [145] 0 0
Poland
State/province [145] 0 0
Otwock
Country [146] 0 0
Romania
State/province [146] 0 0
Alba Iulia
Country [147] 0 0
Romania
State/province [147] 0 0
Baia Mare
Country [148] 0 0
Romania
State/province [148] 0 0
Brasov
Country [149] 0 0
Romania
State/province [149] 0 0
Oradea
Country [150] 0 0
Romania
State/province [150] 0 0
Ploiesti
Country [151] 0 0
Romania
State/province [151] 0 0
Timisoara
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Kazan
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Moscow
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Saint Petersburg
Country [155] 0 0
Russian Federation
State/province [155] 0 0
St. Petersburg
Country [156] 0 0
Slovakia
State/province [156] 0 0
Bardejov
Country [157] 0 0
Slovakia
State/province [157] 0 0
Bratislava
Country [158] 0 0
Slovakia
State/province [158] 0 0
Ruzomberok
Country [159] 0 0
Slovakia
State/province [159] 0 0
Trnava
Country [160] 0 0
South Africa
State/province [160] 0 0
Cape Town
Country [161] 0 0
South Africa
State/province [161] 0 0
Cape town
Country [162] 0 0
South Africa
State/province [162] 0 0
Port Elizabeth
Country [163] 0 0
South Africa
State/province [163] 0 0
Pretoria
Country [164] 0 0
Spain
State/province [164] 0 0
Alicante
Country [165] 0 0
Spain
State/province [165] 0 0
Badalona
Country [166] 0 0
Spain
State/province [166] 0 0
Barcelona
Country [167] 0 0
Spain
State/province [167] 0 0
L'Hospitalet de Llobregat
Country [168] 0 0
Spain
State/province [168] 0 0
Las Palmas de Gran Canaria
Country [169] 0 0
Spain
State/province [169] 0 0
Madrid
Country [170] 0 0
Spain
State/province [170] 0 0
Malaga
Country [171] 0 0
Spain
State/province [171] 0 0
Mataro
Country [172] 0 0
Spain
State/province [172] 0 0
Santiago de Compostela
Country [173] 0 0
Spain
State/province [173] 0 0
Sevilla
Country [174] 0 0
Spain
State/province [174] 0 0
Valencia
Country [175] 0 0
Switzerland
State/province [175] 0 0
Chur
Country [176] 0 0
Taiwan
State/province [176] 0 0
Taichung
Country [177] 0 0
Taiwan
State/province [177] 0 0
Tainan
Country [178] 0 0
Taiwan
State/province [178] 0 0
Taipei
Country [179] 0 0
Taiwan
State/province [179] 0 0
Taoyuan County
Country [180] 0 0
Turkey
State/province [180] 0 0
Ankara
Country [181] 0 0
Turkey
State/province [181] 0 0
Edirne
Country [182] 0 0
Turkey
State/province [182] 0 0
Istanbul
Country [183] 0 0
Turkey
State/province [183] 0 0
Izmir
Country [184] 0 0
Turkey
State/province [184] 0 0
Konya
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Bournemouth
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Bristol
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Exeter
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Glasgow
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Leeds
Country [190] 0 0
United Kingdom
State/province [190] 0 0
London
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Plymouth
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Stevenage
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Wirral

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 main purpose of this study was to demonstrate superiority with regard to overall survival
of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive,
non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.
Trial website
https://clinicaltrials.gov/show/NCT02395172
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono Inc., a business 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