Trial from ClinicalTrials.gov

For full trial details, please see the original record at



Trial ID
NCT02395172
Ethics application status
Date submitted
27/02/2015
Date registered
27/02/2015
Date last updated
21/09/2017

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
Subjects will receive 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous (IV) infusion once every 2 weeks.

Treatment: drugs: Docetaxel
Subjects will receive 75 mg per square meter (m^2) (per label) of docetaxel by IV infusion once every 3 weeks.

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

Outcomes
Primary outcome [1] 0 0
Overall survival (OS) time - The OS is defined as the time from randomization to death due to any cause.
Timepoint [1] 0 0
Time from date of randomization until death, assessed up to 7.6 years
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) Time - PFS is 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 will be assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD is 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.
Timepoint [1] 0 0
Time from date of randomization until progressive disease or death, assessed up to 6.5 years
Secondary outcome [2] 0 0
Best Overall Response (BOR) - BOR will be determined according to RECIST 1.1 and as adjudicated by an IERC. BOR is 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. 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 6.5 years
Secondary outcome [3] 0 0
Change from baseline in 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
Baseline up to 6.5 years
Secondary outcome [4] 0 0
Change from baseline in 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
Baseline up to 6.5 years
Secondary outcome [5] 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) - 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 comprises 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
Baseline up to 6.5 years
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
From the first dose of study drug treatment up to 30 days after the last dose of study drug administration, assessed up to 6.5 years

Eligibility
Key inclusion criteria
Inclusion Criteria

- Signed written informed consent before any trial related procedure

- Male or female subjects 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

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

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

1. Subjects 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. Subjects 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

- Subjects 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). Subjects 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 subjects

- 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, subjects with a squamous cell histology will be excluded

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

- Subjects 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.
Subjects 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 subject has not fully recovered from the surgery within 4
weeks of randomization

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

- All subjects 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. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease
not requiring immunosuppressive treatment are eligible

2. Subjects 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
Blinded (masking 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
Current
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
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Alabama
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Arizona
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Georgia
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Louisiana
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Texas
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Washington
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Argentina
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Bahia Blanca
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Barrio General Paz
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Berazategui
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Ciudad Autonoma Buenos Aires
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Argentina
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Cordoba
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La Rioja
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Parana
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Pilar
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Rosario
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San Miguel de Tucuman
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Belgium
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Edegem
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Gilly
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Leuven
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Liège
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Roeselare
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Pleven
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Sofia
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Bogotá
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Cali
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Medellin
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Medellín
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Monteria
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Croatia
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Dubrovnik
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Zadar
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Zagreb
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Czechia
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Brno
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Novy Jicin
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Pardubice
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Herlev
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Odense C
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Angers Cedex 9
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Besancon Cedex
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Le Mans Cedex 02
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Marseille cedex 20
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Nantes
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Nice cedex 02
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Pessac
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Poitiers
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Saint Herblain
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Strasbourg
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Toulouse
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Hungary
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Budapest
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Hungary
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Györ
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Hungary
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Miskolc
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Hungary
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Torokbalint
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Israel
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Beer Sheva
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Israel
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Beer Yaakov
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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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Tel Aviv
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Italy
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Cremona
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Italy
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Legnago (VR)
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Italy
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Lido di Camaiore
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Italy
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Milano
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Italy
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Napoli
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Italy
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Pisa
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Italy
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Roma
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Italy
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Siena
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Italy
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Treviglio
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Japan
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Chuo-ku
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Fukuoka-shi
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Hiroshima-shi
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Kashiwa-shi
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Kitaadachi-gun
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Kobe-shi
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Koto-ku
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Kurume-shi
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Okazaki-shi
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Osaka-shi
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Osakasayama-shi
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Japan
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Sagamihara-shi
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Sapporo-shi
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Shinjuku-ku
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Japan
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Toyama-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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Cheongju-si
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Korea, Republic of
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Hwasun-gun
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Korea, Republic of
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Incheon
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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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Korea, Republic of
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Suwon-si
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Mexico
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Cuautitlan Izcalli
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Mexico
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Durango
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Mexico
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Leon
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Mexico
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Mexico
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Mexico
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Monterrey
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Mexico
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Morelia
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Mexico
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Oaxaca
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Mexico
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Toluca
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Peru
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Arequipa
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Peru
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Chiclayo
Country [137] 0 0
Peru
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Cusco
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Peru
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Lima
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Poland
State/province [139] 0 0
Brzozow
Country [140] 0 0
Poland
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Jelenia Gora
Country [141] 0 0
Poland
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Katowice
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Mrozy
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Poland
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Otwock
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Romania
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Alba Iulia
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Romania
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Baia Mare
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Romania
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Brasov
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Romania
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Oradea
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Romania
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Ploiesti
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Romania
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Timisoara
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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St. Petersburg
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Slovakia
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Bardejov
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Slovakia
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Bratislava
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Slovakia
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Ruzomberok
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Slovakia
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Trnava
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South Africa
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Cape Town
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South Africa
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Cape town
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South Africa
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Port Elizabeth
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South Africa
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Pretoria
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Spain
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Alicante
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Spain
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Badalona
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Spain
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Barcelona
Country [167] 0 0
Spain
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L'Hospitalet de Llobregat
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Madrid
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Mataro
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Sevilla
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Valencia
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Chur
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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
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Country [181] 0 0
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Edirne
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State/province [183] 0 0
Izmir
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Konya
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United Kingdom
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Bournemouth
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Bristol
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Exeter
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Glasgow
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Leeds
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United Kingdom
State/province [190] 0 0
London
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Plymouth
Country [192] 0 0
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State/province [192] 0 0
Stevenage
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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
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To demonstrate superiority with regard to overall survival of avelumab versus docetaxel in
subjects with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC)
after failure of a platinum-based doublet.
Trial website
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
Contact person responsible for updating information