Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).

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

Details

• Lead Sponsor: Incyte Corporation
• Collaborator: Zai Lab (Shanghai) Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8).

• No prior systemic treatment for the advanced/metastatic NSCLC

• Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy

• Measurable disease per RECIST v1.1.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Life expectancy of at least 3 months.

• Willingness to avoid pregnancy or fathering children.

• Adequate organ function as indicated by protocol-specified laboratory values.

Exclusion Criteria:

• Clinically significant cardiac disease within 6 months of start of study treatment.

• Any major surgery within 3 weeks of the first dose of study treatment.

• Thoracic radiation therapy of > 30 Gy within 6 months of the first dose of study treatment.

• History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel.

• Untreated central nervous system metastases and/or carcinomatous meningitis.

• Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids.

• Active infection requiring systemic therapy or active tuberculosis.

• Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.

• Has contraindications to chemotherapy agents used in the study.

• Has an active autoimmune disease that has required systemic treatment in past 2 years.

• Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment.

• Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug).