NCT02946359

A+C in Metastatic Lung Adenocarcinoma Cancer

Crizotinib Combined With Bevacizumab as First-line Therapy in Metastatic Lung Adenocarcinoma Cancer With ALK Translocation or MET Amplification or ROS1 Translocation (CAMAR)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, prospective, single arm, non comparative study with crizotinib combined with bevacizumab in treatment-naive lung adenocarcinoma cancer patients with ALK translocation or ROS1 translocation or MET amplification

Detailed description

This is a phase II, prospective, single arm, non comparative study with crizotinib combined with bevacizumab in treatment-naive lung adenocarcinoma cancer patients with ALK translocation or ROS1 translocation or MET amplification. Patients with locally advanced or metastatic NSCLC(Stage ⅢB/ⅢC/Ⅳ) with at least one measurable tumor lesion will be considered eligible for the trial. All potentially eligible patients will be evaluated for ALK、MET and ROS1 by FISH or IHC or NGS to detect MET amplification or ALK translocation or ROS1 translocation After evaluation of inclusion and exclusion criteria, and after signature of informed consent form, all MET amplified or ALK translocation or ROS1 translocated eligible patients will receive crizotinib 250 mg BID p.o and bevacizumab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal.

Conditions

• Lung Adenocarcinoma Metastatic

Interventions

Type	Name	Description
DRUG	Crizotinib, bevacizumab	Eligible patients with ALK translocation or ROS1 translocation or MET amplification will be treated with Crizotinib at the standard dose of 250 mg BID and bevacizumab at the dose of 7.5mg/kg every three weeks. The dose of crizotinib and bevacizumab may be adjusted depending on the type and severity of toxicity encountered

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-10-01
• Completion: 2018-07-01
• First posted: 2016-10-27
• Last updated: 2016-11-02

Locations

2 sites across 1 country: China