Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients

Conditions

• Non-squamous NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — BIOLOGICAL
  Pembrolizumab was given as 200 milligrams (mg) via intravenous (IV) infusion over 30 minutes on Day 1 of each 21-day cycle.
• Bevacizumab — BIOLOGICAL
  Bevacizumab was given as 15 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle.
• Pemetrexed — DRUG
  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.
• Cisplatin — DRUG
  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.
• Carboplatin — DRUG
  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.
• 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.
• 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 on the same day as pemetrexed administration.
• Dexamethasone 4 mg — DRUG
  For prophylaxis; orally twice per day (or equivalent). Taken the day before, the day of, and the day after pemetrexed administration.

Study Details

This study is designed to evaluate the efficacy and safety of Pembrolizumab in combination with Bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutation.

Key Dates

First listed

Mar 2, 2023

Start date

Jun 27, 2023

Status verified

Mar 2026

Primary completion

Dec 15, 2025

Completion

Dec 30, 2027

Study Design

Enrollment

54 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pembrolizumab + Bevacizumab + Chemotherapy
  Participants receive pembrolizumab 200 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 4-6 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]