Avelumab in First Line Non-Small Cell Lung Cancer

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001537-24-PT

Enrollment

1131

Registered

2015-11-19

Start date

2016-05-30

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Line Non-Small Cell Lung Cancer MedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10029515 Term: Non-small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10061

Interventions

Trade Name: Bavencio Product Name: Avelumab Product Code: MSB0010718C Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Avelumab Current Sponsor code: MSB0010718C Other d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key inclusion criteria: Male or female subjects = 18 years, with an ECOG PS of 0 to 1 at trial entry, with the availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 10 (preferably 25) unstained tumor slides with PD-L1+, at least 1 measurable tumor lesion, and with histologically confirmed metastatic or recurrent (Stage IV) NSCLC. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 543 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 588

Exclusion criteria

Exclusion criteria: Key exclusion criteria: Subjects whose disease harbors a EFGR mutation or an 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 =10mg 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate superiority with regard to OS or PFS of avelumab versus platinum-based double, based on an Independent Review Committee assessment, in NSCLC subjects with high expression PD-L1+ tumors;Secondary Objective: Secondary objectives are as follows: -To demonstrate superiority with regard to OS or PFS based on an IRC assessment in NSCLC subjects with moderate and high expression PD-L1+ tumors -To demonstrate superiority with regard to OS in NSCLC subjects with any expression PD L1+ tumors -To comparatively assess the ORR by RECIST 1.1 of avelumab versus chemotherapy in high, moderate and high, and any expression PD-L1+ tumours To determine DOR of avelumab versus chemotherapy -To compare the subject-reported outcomes / quality of life when treated with avelumab versus chemotherapy using the European Quality of Life (EuroQOL) 5-dimensions 5-level questionnaire (EQ-5D-5L), and the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 and module QLQ-LC13 -To determine the safety and tolerability of avelumab;Primary end point(s): • Progression Free Survival (PFS) for subjects with high PD-L1 + expression • Overall Survival (OS) for subjects with high PD-L1 + expression;Timepoint(s) of evaluation of this end point: PFS: Time from date of randomization until PD or death, assessed up to 39 months OS: Time from date of randomization until death, assessed up to 49 months	—

Measure

Time frame

Main Objective: To demonstrate superiority with regard to OS or PFS of avelumab versus platinum-based double, based on an Independent Review Committee assessment, in NSCLC subjects with high expression PD-L1+ tumors;Secondary Objective: Secondary objectives are as follows: -To demonstrate superiority with regard to OS or PFS based on an IRC assessment in NSCLC subjects with moderate and high expression PD-L1+ tumors -To demonstrate superiority with regard to OS in NSCLC subjects with any expression PD L1+ tumors -To comparatively assess the ORR by RECIST 1.1 of avelumab versus chemotherapy in high, moderate and high, and any expression PD-L1+ tumours To determine DOR of avelumab versus chemotherapy -To compare the subject-reported outcomes / quality of life when treated with avelumab versus chemotherapy using the European Quality of Life (EuroQOL) 5-dimensions 5-level questionnaire (EQ-5D-5L), and the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 and module QLQ-LC13 -To determine the safety and tolerability of avelumab;Primary end point(s): • Progression Free Survival (PFS) for subjects with high PD-L1 + expression • Overall Survival (OS) for subjects with high PD-L1 + expression;Timepoint(s) of evaluation of this end point: PFS: Time from date of randomization until PD or death, assessed up to 39 months OS: Time from date of randomization until death, assessed up to 49 months

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: • 1. Best Overall Response (BOR) as adjudicated by the IRC 2. Duration of Response (DOR) 3. Change from baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire 4. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status 5. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) 6. 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 7. Number of subjects with abnormalities in safety laboratory tests as graded by NCI-CTCAE (Version 4.03) 8. Number of subjects with abnormalities in vital signs, physical examination, and Eastern Cooperative Oncology Group (ECOG) PS. 9. Number of subjects with abnormalities in 12-lead ECG Progression Free Survival (PFS) for subjects with moderate and high PD-L1 + expression Overall Survival (OS) for subjects with moderate and high and any PD-L1 + expression;Timepoint(s) of evaluation of this end point: 1. Time from date of randomization up to 49 months 2. Time from date of randomization up to 49 months 3. Time Frame: Baseline up to 49 months 4. Time Frame: Baseline up to 49 months 5. Time Frame: Baseline up to 49 months 6. Time Frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug administration 7. Time Frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug administration 8. Time Frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug administration 9. Time Frame: Screening and at the End-of-Treatment visit	—

Measure

Time frame

Secondary end point(s): Secondary endpoints: • 1. Best Overall Response (BOR) as adjudicated by the IRC 2. Duration of Response (DOR) 3. Change from baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire 4. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status 5. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) 6. 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 7. Number of subjects with abnormalities in safety laboratory tests as graded by NCI-CTCAE (Version 4.03) 8. Number of subjects with abnormalities in vital signs, physical examination, and Eastern Cooperative Oncology Group (ECOG) PS. 9. Number of subjects with abnormalities in 12-lead ECG *Progression Free Survival (PFS) for subjects with moderate and high PD-L1 + expression *Overall Survival (OS) for subjects with moderate and high and any PD-L1 + expression;Timepoint(s) of evaluation of this end point: 1. Time from date of randomization up to 49 months 2. Time from date of randomization up to 49 months 3. Time Frame: Baseline up to 49 months 4. Time Frame: Baseline up to 49 months 5. Time Frame: Baseline up to 49 months 6. Time Frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug administration 7. Time Frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug administration 8. Time Frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug administration 9. Time Frame: Screening and at the End-of-Treatment visit

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Countries

Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactCommunication Center Merck KGaA

Merck KGaA

service@merckgroup.com+49 6151 72 5200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026