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Tyrosine Kinase Inhibitor

Gefitinib + Anlotinib for Non-Small Cell Lung Cancer (FL-ALTER Trial)

Phase 3
Waitlist Available
Research Sponsored by Sun Yat-sen University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progress-free survival (PFS)
Secondary study objectives
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1
Overall Survival (OS)
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1
+1 more
Other study objectives
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Gefitinib + AnlotinibExperimental Treatment2 Interventions
Patients will be treated with Gefitinib 250mg, p.o., qd and anlotinib hydrochloride capsule 12mg, p.o., qd, D1-D14; take on an empty stomach (take at the same time every day as possible), every 3 weeks for a cycle.
Group II: Gefitinib + PlaceboPlacebo Group2 Interventions
Patients will be treated with Gefitinib 250mg, p.o., qd and placebo to simulate anlotinib hydrochloride capsule 12mg, p.o., qd, D1-D14; take on an empty stomach (take at the same time every day as possible), every 3 weeks for a cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gefitinib
FDA approved
Anlotinib Hydrochloride
2019
Completed Phase 4
~170

Find a Location

Who is running the clinical trial?

Sun Yat-sen UniversityLead Sponsor
1,577 Previous Clinical Trials
3,487,203 Total Patients Enrolled
~48 spots leftby Sep 2025