Actively Recruiting
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）
Led by Allist Pharmaceuticals, Inc. · Updated on 2025-06-08
338
Participants Needed
2
Research Sites
361 weeks
Total Duration
On this page
Sponsors
A
Allist Pharmaceuticals, Inc.
Lead Sponsor
A
ArriVent BioPharma, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age 18 years or older (20 years or older for participants from Japan/Taiwan).
- Confirmed diagnosis of primary non-small cell lung cancer with mostly non-squamous cells.
- Complete surgical removal of the primary lung tumor with lymph node dissection (R0 resection).
- Postoperative cancer stage IB, II, IIIA, or IIIB (T3N2M0 only) based on the 9th Edition TNM staging.
- Documented uncommon EGFR mutations (exon 20 insertion, PACC, classical-like) in tumor tissue or blood using validated tests.
You will not qualify if you...
- NSCLC with EGFR Exon 19 deletion, L858R, or C797S mutation.
- Incomplete tumor removal (R1/R2), or only segmentectomy or wedge resection performed.
- Prior treatment with any antineoplastic therapy other than standard platinum-based doublet adjuvant chemotherapy.
- Prior neoadjuvant therapy.
- Presence of other active cancers except for those that are locally treated and cured.
- History of interstitial lung disease (ILD), including drug-induced ILD, or active ILD/active radiation pneumonitis.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, China, 510060
Actively Recruiting
Research Team
L
Li Zhang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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