Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients

PHASE2RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

June 27, 2023

Primary Completion Date

March 30, 2026

Study Completion Date

March 30, 2027

Conditions
Non-squamous NSCLC
Interventions
BIOLOGICAL

Pembrolizumab

Pembrolizumab was given as 200 milligrams (mg) via intravenous (IV) infusion over 30 minutes on Day 1 of each 21-day cycle.

BIOLOGICAL

Bevacizumab

Bevacizumab was given as 15 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle.

DRUG

Pemetrexed

Pemetrexed was given as 500 mg/m\^2 via intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle for 4-6 cycles.

DRUG

Cisplatin

Cisplatin was given as 75 mg/m\^2 via intravenous (IV) infusion (administered approximately 30 minutes after pemetrexed infusion) on Day 1 of each 21-day cycle for 4-6 cycles.

DRUG

Carboplatin

Carboplatin was given as Aare Under the Curve (AUC) 5 (5 mg/mL/min; over 15-60 min) via intravenous (IV) infusion (administered immediately after pemetrexed infusion) on Day 1 of each 21-day cycle for 4-6 cycles.

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 on the same day as pemetrexed administration.

DRUG

Dexamethasone 4 mg

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

Trial Locations (1)

Unknown

RECRUITING

Shanghai Chest Hospital, Shanghai

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Shanghai Chest Hospital

OTHER