Avelumab in First-line NSCLC (JAVELIN Lung 100)

• Status: Active, not recruiting
• Trial end date: 2025-06-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) subjects with Programmed death ligand 1+ (PD-L1+) tumors

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Avelumab; Carboplatin; Cisplatin; Gemcitabine; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

• Male or female subjects aged greater than or equal to (>=) 18 years

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

• At least 1 measurable tumor lesion

• With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC)

• With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6 months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1 week, and suitable for PD-L1 expression assessment

• 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

Exclusion Criteria:

• Subjects whose disease harbors a EGFR mutation, or 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 <= 10 mg 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