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Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients

NCT05751187 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-03-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Baohui Han, MD,PhD · Shanghai Chest Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-27
Primary Completion
2025-12-15
Completion
2027-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05751187 on ClinicalTrials.gov