NCT03002844

EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Detailed description

BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Conditions

• Nonsmall Cell Lung Cancer
• EGFR Gene Mutation

Interventions

Type	Name	Description
DRUG	EGFR-TK Inhibitor	EGFR-TKI (gefitinib 250mg per day)
DRUG	EGFR-TKI	EGFR-TKI (gefitinib 250mg per day)
DRUG	EGFR-TKI and Chemotherapy	pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-08-01
• Completion: 2018-12-01
• First posted: 2016-12-26
• Last updated: 2016-12-28