Avelumab in First Line Non-Small Cell Lung Cancer

Phase 1

• 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 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001537-24-GB
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-24
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1131

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 7 (preferably 10) unstained tumor slides with PD-L1+, at least 1 measurable tumor lesion, and with histologically confirmed metastatic or recurrent 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: 0
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

Key exclusion criteria:
Subjects whose disease harbors an activating EFGR mutation, or with non-squamous cell NSCLC whose disease harbors and 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 enrollment, 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. All potential exceptions must be discussed with the study Medical Monitor prior to enrollment.

Other protocol defined criteria could apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified