NCT04028778

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

A Multicenter, Randomized, Double-Blind Study of Gefitinib in Combination With Anlotinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-Small-Cell Lung Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-04-10
• Primary completion: 2020-12-01
• Completion: 2022-12-01
• First posted: 2019-07-23
• Last updated: 2019-11-08

Locations

1 site across 1 country: China