RecruitingPhase 3NCT07010419

A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy(FIRMOST)

A Global Phase 3, Double-Blind, Randomized, Controlled Multicenter Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy (FIRMOST)


Sponsor

Allist Pharmaceuticals, Inc.

Enrollment

338 participants

Start Date

May 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 3, global, double-blind, randomized, controlled multicenter clinical study to assess the efficacy and safety of adjuvant treatment with firmonertinib versus placebo in participants with Stage IB-IIIB NSCLC with uncommon EGFR mutations (exon 20 insertions, PACC and classical-like mutations) after complete surgical resection with or without adjuvant chemotherapy. About 338 eligible participants will be enrolled and randomized in a 1:1 ratio to receive either firmonertinib 240 mg QD or placebo QD in 21-day treatment cycles. Before randomization, the participant must have undergone complete surgical resection (R0 resection), must have sufficiently recovered from surgery, and must have completed adjuvant chemotherapy (if applicable). The participants will receive firmonertinib or placebo as adjuvant treatment until unacceptable toxicity, withdrawal of informed consent, disease recurrence, initiation of new antitumor treatment, completion of treatment, or other end of treatment reason is met.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Firmonertinib and a drug called Placebo for people with adjuvant treatment and nsclc. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFirmonertinib

Firmonertinib: 240 mg, QD, orally

DRUGPlacebo

Placebo: 240 mg, QD, orally


Locations(2)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangdong, Guangzhou, China

View Full Details on ClinicalTrials.gov

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NCT07010419


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