NCT05751187

Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients

Pembrolizumab Plus Bevacizumab and Chemotherapy as First-Line Treatment for Advanced or Metastatic Non-Squamous NSCLC Patients With EGFR Exon 20 Insertion Mutation: An Open-Label, Single-Arm, Phase II Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-squamous NSCLC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-27
• Primary completion: 2025-12-15
• Completion: 2027-12-30
• First posted: 2023-03-02
• Last updated: 2026-03-11

Locations

1 site across 1 country: China