NCT01951482

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

Bevacizumab+Pemetrexed/Platinum Versus Pemetrexed/Platinum as First-line Therapy in EGFR/ALK Negative Non-squamous Non-small Cell Lung Cancer Patients With Brain Metastases: a Multicenter, Randomized, Controlled, Phase 3 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Non Squamous Non-small Cell Lung Cancer
• Brain Metastases
• Bevacizumab

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2013-09-26
• Last updated: 2025-08-17

Locations

1 site across 1 country: China