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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02395172




Registration number
NCT02395172
Ethics application status
Date submitted
27/02/2015
Date registered
20/03/2015

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)
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
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
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
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
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
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
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
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)
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)
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)
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)
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
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
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
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
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
Sex
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
24/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/12/2019
Sample size
Target
Accrual to date
Final
792
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
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United States of America
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Arizona
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Michigan
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New York
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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Pennsylvania
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Tennessee
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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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Argentina
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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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Edegem
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Leuven
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Liège
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Zadar
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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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Györ
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Miskolc
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Israel
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Beer Yaakov
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Haifa
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Jerusalem
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Kfar-Saba
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Petach Tikva
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Cremona
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Legnago (VR)
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Lido di Camaiore
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Hwasun-gun
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Incheon
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Seongnam-si
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Seoul
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Suwon-si
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Cuautitlan Izcalli
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Durango
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Leon
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Mexico
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Mexico
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Monterrey
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Morelia
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Oaxaca
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Mexico
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Toluca
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Chiclayo
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Peru
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Cusco
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Peru
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Lima
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Poland
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Brzozow
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Jelenia Gora
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Katowice
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Lodz
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Lublin
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Mrozy
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Otwock
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Brasov
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Oradea
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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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Russian Federation
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Slovakia
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Bratislava
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Slovakia
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Ruzomberok
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Cape town
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Barcelona
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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
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02395172