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Pemetrexed/Platinum With or Without Bevacizumab in Brain Metastases From Patients With EGFR/ALK Negative Non-Squamous Non-small Cell Lung Cancer

NCT01951482 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-08-17

No results posted yet for this study

Summary

This is a multi-center phase 3 randomized controlled study to assess the efficacy of Pemetrexed/platinum with or without Bevacizumab on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR/ALK wild type by intracranial PFS(iPFS), also PFS ,ORR, DCR and OS. The safety is evaluated as well.

Conditions

Interventions

DRUG

Pemetrexed/Platinum

pemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle for four to six cycles, followed by pemetrexed maintenance every 3 weeks.

DRUG

Bevacizumab and Pemetrexed/platinum

bevacizumab (7.5mg/kg, intravenously on day 1 of each 3-week cycle) plus pemetrexed-platinum chemotherapy (pemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle) for four to six cycles, followed by bevacizumab plus pemetrexed maintenance every 3 weeks.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • li-kun Chen, Doctor · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT01951482 on ClinicalTrials.gov