Trial Outcomes & Findings for Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC (NCT NCT04786964)

NCT ID: NCT04786964

Last Updated: 2025-04-02

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

25 participants

Primary outcome timeframe

Approximately 3 years.

Results posted on

2025-04-02

Participant Flow

Subjects were randomized 2:1 to receive cosibelimab 1200 mg in combination with pemetrexed and platinum therapy, or pemetrexed and platinum therapy alone. The platinum therapy, cisplatin, or carboplatin was based on Investigator's choice. Subjects were stratified by smoking status (never vs former/current), cisplatin vs carboplatin, and PD-L1 status prior to randomization. Subjects with unevaluable PD-L1 status were included with the TPS \< 1% group.

Participant milestones

Participant milestones
Measure	Cosibelimab 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. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion 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. 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. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.	Control 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. Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion 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. 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. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
Overall Study STARTED	19	6
Overall Study COMPLETED	19	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cosibelimab n=19 Participants 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. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion 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. 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. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.	Control n=6 Participants 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. Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion 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. 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. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	6 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	6 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Russia	19 participants n=5 Participants	6 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 3 years.

Population: Due to the Russia/Ukraine conflict initiating during the study start up, the study was put on hold, and then the study terminated prior to efficacy analysis. This study will not be used to support marketing application approval.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 3 years.

Defined as the time from randomization until disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 3 years.

Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 3 years.

Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1) or death from any cause, whichever comes first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 2 years.

Population: Adverse event monitoring was performed throughout the study; after the end of treatment, subjects were followed for a minimum of 30 days for AE monitoring through the end of the study, which was up to 2 years.

An AE is defined as any untoward medical occurrence in a study participant administered study drug and which does not necessarily have to have a causal relationship with this study drug.

Outcome measures

Outcome measures
Measure	Cosibelimab n=19 Participants 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. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion 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. 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. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.	Control n=6 Participants 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. Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion 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. 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. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
Number of Participants Who Experienced an Adverse Event (AE)	14 Participants	6 Participants

Adverse Events

Cosibelimab

Serious events: 2 serious events

Other events: 14 other events

Deaths: 1 deaths

Control

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cosibelimab n=19 participants at risk 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. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion 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. 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. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.	Control n=6 participants at risk 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. Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion 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. 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. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.3% 1/19 • Number of events 1 • Adverse event monitoring was performed throughout the study; after the end of treatment, subjects were followed for a minimum of 30 days for AE monitoring and up to 90 days for SAEs and irAEs through study completion, up to 24 months. Note the study was prematurely terminated due to the geopolitical conflict in the region.	0.00% 0/6 • Adverse event monitoring was performed throughout the study; after the end of treatment, subjects were followed for a minimum of 30 days for AE monitoring and up to 90 days for SAEs and irAEs through study completion, up to 24 months. Note the study was prematurely terminated due to the geopolitical conflict in the region.
Blood and lymphatic system disorders Pancytopenia	5.3% 1/19 • Number of events 1 • Adverse event monitoring was performed throughout the study; after the end of treatment, subjects were followed for a minimum of 30 days for AE monitoring and up to 90 days for SAEs and irAEs through study completion, up to 24 months. Note the study was prematurely terminated due to the geopolitical conflict in the region.	0.00% 0/6 • Adverse event monitoring was performed throughout the study; after the end of treatment, subjects were followed for a minimum of 30 days for AE monitoring and up to 90 days for SAEs and irAEs through study completion, up to 24 months. Note the study was prematurely terminated due to the geopolitical conflict in the region.
Respiratory, thoracic and mediastinal disorders COVID-19	0.00% 0/19 • Adverse event monitoring was performed throughout the study; after the end of treatment, subjects were followed for a minimum of 30 days for AE monitoring and up to 90 days for SAEs and irAEs through study completion, up to 24 months. Note the study was prematurely terminated due to the geopolitical conflict in the region.	16.7% 1/6 • Number of events 1 • Adverse event monitoring was performed throughout the study; after the end of treatment, subjects were followed for a minimum of 30 days for AE monitoring and up to 90 days for SAEs and irAEs through study completion, up to 24 months. Note the study was prematurely terminated due to the geopolitical conflict in the region.

Other adverse events

Additional Information

James Oliviero

Checkpoint Therapeutics

Phone: 212-574-2830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor owns and publishes clinical trial results. The PI cannot publish results unless and until requested in writing by the sponsor.
Publication restrictions are in place

Restriction type: OTHER