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

NCT04786964 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: CK-301-301
• Study Type: interventional
• Target: 25
• Locations: 8 countries
• Sites: 22

Brief 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.

Conditions

Metastatic Non-squamous Non Small Cell Lung Cancer

Keywords

Metastatic; non-small cell lung cancer; nonsquamous; PD-L1; PD-1; PDL1; PD1; Lung neoplasms; Cosibelimab; Non-squamous NSCLC; Carcinoma, non-small cell lung; Antineoplastic agents; CK-301; Anti-PD-L1

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Defined as the time from randomization to death due to any cause.

  Approximately 3 years.

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  Approximately 3 years.

• Objective Response Rate (ORR)

  Approximately 3 years.

• Duration of Response (DOR)

  Approximately 3 years.

• Number of Participants Who Experienced an Adverse Event (AE)

  Approximately 2 years.

Study Arms (2)

Cosibelimab

EXPERIMENTAL

Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression.

Drug: Cosibelimab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Dietary Supplement: Folic acid 350-1000 μg; Dietary Supplement: Vitamin B12 1000 μg; Drug: Dexamethasone 4mg

Control

ACTIVE COMPARATOR

Participants receive pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pemetrexed 500 mg/m\^2 IV Q3W until progression.

Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Dietary Supplement: Folic acid 350-1000 μg; Dietary Supplement: Vitamin B12 1000 μg; Drug: Dexamethasone 4mg

Interventions

Cosibelimab DRUG

IV infusion

Cosibelimab

Cisplatin DRUG

IV infusion

Control; Cosibelimab

Carboplatin DRUG

IV infusion

Control; Cosibelimab

Pemetrexed DRUG

IV infusion

Control; Cosibelimab

Folic acid 350-1000 μg DIETARY_SUPPLEMENT

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.

Control; Cosibelimab

Vitamin B12 1000 μg DIETARY_SUPPLEMENT

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.

Control; Cosibelimab

Dexamethasone 4mg DRUG

For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.

Control; Cosibelimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
• Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated.
• Has measurable disease.
• Has not received prior systemic treatment for their advanced/metastatic NSCLC.
• Can provide tumor tissue.
• Has a life expectancy of at least 3 months.
• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
• Has adequate organ function
• If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
• If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 180 days after the last dose of study medication and chemotherapeutic agents.

You may not qualify if:

• Has predominantly squamous cell histology NSCLC.
• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of study medication.
• Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab), c) Had major surgery (\<3 weeks prior to first dose).
• Received radiation therapy to the lung that is \>30 Gray (Gy) within 6 months of the first dose of study medication.
• Completed palliative radiotherapy within 7 days of the first dose of study medication.
• Is expected to require any other form of antineoplastic therapy while on study.
• Received a live-virus vaccination within 30 days of planned start of study medication.
• Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, peritoneal carcinomatosis.
• Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb).
• Known sensitivity to any component of cisplatin, carboplatin or pemetrexed.
• Has active autoimmune disease that has required systemic treatment in past 2 years.
• Is on chronic systemic steroids.
• Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).

Sponsors & Collaborators

• Checkpoint Therapeutics, Inc.: lead

Study Sites (22)

Research Site

Vitória, Brazil

Location

Research Site

Tbilisi, Georgia

Location

Research Site

Kota Bharu, Malaysia

Location

Research Site

Wellington, New Zealand

Location

Research Site

Lima, Peru

Location

Research Site

Arkhangelsk, Russia

Location

Research Site

Chelyabinsk, Russia

Location

Research Site

Kaliningrad, Russia

Location

Research Site

Kazan', Russia

Location

Research Site

Kursk, Russia

Location

Research Site

Kuzmolovskiy, Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Nizhny Novgorod, Russia

Location

Research Site

Novosibirsk, Russia

Location

Research Site

Omsk, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Samara, Russia

Location

Research Site

Sochi, Russia

Location

Research Site

Tomsk, Russia

Location

Research Site

Volgograd, Russia

Location

Research Site

Pretoria, South Africa

Location

Research Site

Chiang Mai, Thailand

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Cisplatin; Carboplatin; Pemetrexed; Folic Acid; Vitamin B 12; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Pterins; Pteridines; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: James Oliviero
• Organization: Checkpoint Therapeutics

jfo@checkpointtx.com

212-574-2830

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 8, 2021
• Study Start: December 8, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-03

Locations

RU (15); MY (1); GE (1); TH (1); NZ (1); BR (1); PE (1); ZA (1)