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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）

NCT07010419 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2025-06-08

No results posted yet for this study

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.

Conditions

  • NSCLC
  • Adjuvant Treatment

Interventions

DRUG

Firmonertinib

Firmonertinib: 240 mg, QD, orally

DRUG

Placebo

Placebo: 240 mg, QD, orally

Sponsors & Collaborators

  • ArriVent BioPharma, Inc.

    collaborator INDUSTRY

  • Allist Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, Master · Sun Yat-sen University

  • Fan Yang, Doctor · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-28
Primary Completion
2028-10-31
Completion
2032-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT07010419 on ClinicalTrials.gov