Avelumab in First-line NSCLC (JAVELIN Lung 100)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3

Conditions: First Line Non-Small Cell Lung Cancer

Treatments: Drug: Avelumab Weekly; Drug: Carboplatin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Cisplatin; Drug: Avelumab; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576574

EMR 100070-005

2015-001537-24 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study was 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) participants with Programmed death ligand 1+ (PD-L1+) tumors.

Enrollment: 1,214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,214 participants in 3 patient groups

Avelumab Biweekly

Experimental group

Treatment:

Drug: Avelumab

Avelumab Weekly

Experimental group

Treatment:

Drug: Cisplatin

Drug: Avelumab Weekly

Chemotherapy

Active Comparator group

Treatment:

Drug: Gemcitabine

Drug: Pemetrexed

Drug: Paclitaxel

Drug: Gemcitabine

Drug: Carboplatin

Drug: Carboplatin