Clinical Trials Logo

Clinical Trial Summary

This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of combination of gefitinib and doublet chemotherapy or antiangiogenesis in advanced non-small cell lung cancer patients with EGFR activating mutation, accompanied with Bim deletion or low activating EGFR mutation abundance.


Clinical Trial Description

BIM deletion polymorphism and low EGFR mutation abundance were poor clinical response markers to EGFR-TKIs in NSCLC patients who had EGFR mutations.This is a phase II clinical trial to investigate the efficacy of combination treatment for patients harboring risk factors.

Advanced EGFR mutated NSCLC Patients with Bim deletion or EGFR low mutation abundance were randomizely divided into three treatment groups:

A:Gefitinib 250mg Qd B:Gefitinib 250mg Qd combined with doublet chemotherapy: Pemetrexed (500mg/m²day 1 intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days, Gemcitabine (1000 mg/m² days 1, day8, intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days C:Gefitinib 250mg Qd combined with bevacizumab 7.5mg/kg intravenously per 21 days. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02930954
Study type Interventional
Source Tongji University
Contact Caicun Zhou, MD,PhD
Phone 86-21-65115006
Email caicunzhoudr@163.com
Status Not yet recruiting
Phase Phase 2
Start date November 2016
Completion date December 2018

See also
  Status Clinical Trial Phase
Terminated NCT02495233 - A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI) Phase 1/Phase 2
Withdrawn NCT02672358 - Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC Phase 2
Recruiting NCT05815472 - Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT) N/A
Not yet recruiting NCT05900219 - Efficacy and Safety of HL-085 Combined With Vemurafenib in BRAF V600E Patients With Non-small Cell Lung Cancer: a Phase II Clinical Study Phase 2
Not yet recruiting NCT04560244 - A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment Phase 2
Not yet recruiting NCT02907606 - Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study N/A
Completed NCT01924416 - Lung Cancer Information Study (LCIS-R01) N/A
Completed NCT01136083 - Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients N/A
Completed NCT00831454 - Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection N/A
Completed NCT00363766 - Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer Phase 2
Completed NCT00913705 - Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer Phase 3
Completed NCT01124864 - A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy. Phase 2
Completed NCT01383135 - Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2 Early Phase 1
Completed NCT00049998 - Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer Phase 3
Terminated NCT05061537 - Study of PF-07263689 in Participants With Selected Advanced Solid Tumors Phase 1
Completed NCT03320044 - Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing
Recruiting NCT04895930 - Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC Phase 2
Recruiting NCT03267654 - Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance Phase 2
Recruiting NCT04401059 - Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC:Prospective Study Phase 4
Not yet recruiting NCT02938546 - 18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study Phase 3