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Gefitinib in Combination With Anlotinib or Placebo in Previously Untreated EGFR-mutant NSCLC

NCT04028778 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2019-11-08

No results posted yet for this study

Summary

Gefitinib is currently the standard-of-care for patients with activating-EGFR mutant advanced non-small cell lung cancer (NSCLC). However, \~30-40% patients are still nonresponsive, and experience significantly varying duration of response and survival rate. Anlotinib is an efficient multi-target tyrosine kinase inhibitor (TKI) that effectively block the migration and proliferation of endothelial cells and reduce tumor microvascular density by targeting VEGFRs, FGFRs, PDGFRs. It has been proved to be safe and effective in advanced lung cancer after second-line standard chemotherapy failure, which can significantly extend the survival of patients and approves as a third-line treatment for advanced NSCLC. Here, we prepared to evaluate whether the combination of gefitinb and anlotinib can preferably improved survival of untreated NSCLC with EGFR activating mutation.

Conditions

  • Lung Cancer, Nonsmall Cell

Interventions

DRUG

Gefitinib

Gefitinib 250mg, p.o., qd, D1-D21; 3 weeks one cycle.

DRUG

Anlotinib Hydrochloride

Anlotinib hydrochloride capsule 12mg, p.o., qd, D1-D14; 3 weeks one cycle.

OTHER

Placebo

Placebo simulating anlotinib hydrochloride capsule 12mg, p.o., qd, D1-D14; 3 weeks one cycle.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2020-12-31
Completion
2022-12-31

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 NCT04028778 on ClinicalTrials.gov