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Intercalating and Maintenance Gefitinib in Combination With Chemotherapy for Advanced EGFR-mutant NSCLC

NCT02299765 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2017-11-27

No results posted yet for this study

Summary

Study Title:

Intercalating and maintenance Gefitinib in combination with chemotherapy (gemcitabine plus carboplatin) as first-line treatment for patients with advanced EGFR mutation-positive non-small cell lung cancer: A randomized, open-label, multiple-centre study.

Target population-Treatment naive EGFR mutant-positive advanced NSCLC patients.

Study Objectives - Primary Study Objective: To investigate whether intercalating and maintenance Gefitinib in combination with chemotherapy improve the Progression-Free Survival (PFS) vs. Gefitinib alone in advanced NSCLC with EGFR activating mutation.

\- Secondary Study Objective： To evaluate whether intercalating and maintenance Gefitinib in combination with chemotherapy improve the Objective Response Rate (ORR), Disease control rate (DCR), Overall survival (OS), 2-year OS rate, QOL vs. Gefitinib alone.

Evaluation the safety of Intercalating and Maintenance Gefitinib in combination with chemotherapy.

\- Exploratory objective: PFS of arm A vs. PFS 1 + PFS 2 of arm B Dynamic biomarker analysis using blood sample

a: The PFS 1 of arm B is the time from randomization to disease progression of 1st-line therapy or death from any cause, whichever occurs first. The PFS 2 of arm B is the time from the time of PFS 1 to disease progression of 2nd-line therapy or death from any cause, whichever occurs first.

Study Design-Prospective, open-label, randomized, multi-center study.

Conditions

  • Non-small Cell Lung Cancer Metastatic
  • EGFR Activating Mutation

Interventions

DRUG

Gefitinib

patients in arm A will be given gefitinib as target therapy

DRUG

gemcitabine

patients in arm A will be given gemcitabine chemotherapy

DRUG

carboplatin

patients in arm A will be given carboplatin chemotherapy

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Sichuan University

    lead OTHER

Principal Investigators

  • You Lu, MD · Department of Thoracic Oncology, Cancer center, West China Hospital, Sichuan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • China

Study Locations

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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 NCT02299765 on ClinicalTrials.gov