NCT04786964

Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC

A Randomized, Open-Label, Phase 3 Study of Cosibelimab (CK-301) in Combination With Platinum+Pemetrexed Chemotherapy in Subjects With First-Line Metastatic Non-squamous Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Checkpoint Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an efficacy and safety study of cosibelimab (CK-301) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned in a 2:1 ratio to receive cosibelimab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin). The primary hypothesis is that cosibelimab in combination with pemetrexed/platinum chemotherapy prolongs Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.

Detailed description

CK-301-301 is a Phase 3, open-label, multicenter, randomized, active-controlled study of the safety and efficacy of IV administered cosibelimab 1200 mg Q3W in combination with platinum/pemetrexed chemotherapy versus chemotherapy alone in subjects with NSCLC who have not previously received systemic therapy for advanced disease and in whom epidermal growth factor receptor-directed therapy or anaplastic lymphoma kinase-directed therapy was not indicated. Subjects were randomized 2:1 to receive cosibelimab 1200 mg in combination with pemetrexed and platinum therapy, or pemetrexed and platinum therapy alone. Subjects were stratified by smoking status (never versus former/current), cisplatin vs carboplatin, and PD-L1 status (Tumor Proportion Score \[TPS\] \< 1% vs 1-49% vs ≥ 50%) prior to randomization. Subjects with unevaluable PD-L1 status were included with the TPS \< 1% group.

Conditions

• Metastatic Non-squamous Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cosibelimab	IV infusion
DRUG	Cisplatin	IV infusion
DRUG	Carboplatin	IV infusion
DRUG	Pemetrexed	IV infusion
DIETARY_SUPPLEMENT	Folic acid 350-1000 μg	Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
DIETARY_SUPPLEMENT	Vitamin B12 1000 μg	Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.
DRUG	Dexamethasone 4mg	For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.

Timeline

• Start date: 2021-12-08
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2021-03-08
• Last updated: 2025-04-02
• Results posted: 2025-04-02

Locations

22 sites across 8 countries: Brazil, Georgia, Malaysia, New Zealand, Peru, Russia, South Africa, Thailand

Regulatory

• FDA-regulated drug study