Clinical trial NCT07010419: 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）
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: NSCLC
Adjuvant Treatment
Keywords: EGFR
NSCLC
Firmonertinib
Lead sponsor: Allist Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ArriVent BioPharma, Inc.
First posted: 2025-06-08
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. Sign the Informed Consent Form (ICF).
2. Aged ≥ 18 years old. Participants from Japan/Taiwan aged ≥ 20 years old.
3. Histologically confirmed diagnosis of primary non-small cell lung cancer (NSCLC) of predominantly non-squamous histology.
4. Underwent complete surgical resection of primary lung cancer and systematic lymph node dissection (R0 resection).
5. Classified post-operatively as Stage IB, II, IIIA, or IIIB (T3N2M0 only) on the basis of pathologic criteria, with the disease staging following the 9th Edition TNM Staging Classification: Lung Cancer issued by Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC).
6. Documented results of the presence of uncommon EGFR mutations (exon 20 insertion mutations, PACC mutations, and/or classical-like mutations, either as single mutations or as co-mutations), in tumor tissue or blood via a validated NGS or validated PCR assay.

Exclusion Criteria:

A participant would be excluded from the study if he/she meets any of the following:

1. NSCLC with EGFR Exon 19 deletion or L858R or C797S mutation.
2. Incomplete resection (R1/R2) or segmentectomy or wedge resection only.
3. Prior treatment with any of the following:

   1. Prior treatment with any antineoplastic therapy other than standard platinum-based doublet adjuvant chemotherapy.
   2. prior treatment with neoadjuvant therapy.
4. Concurrent malignant tumors other than the primary tumor; participants with cancers that can be treated locally and cured may be eligible.
5. Previous ILD (including drug-induced ILD) or active ILD/active radiation pneumonitis.

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Disease free survival (DFS)
timeFrame: Up to 3 years
measure: Disease free survival (DFS)
timeFrame: Up to 3 years
measure: Disease free survival rates
timeFrame: Up to 5 years
measure: Overall survival (OS)
timeFrame: Up to 5 years
measure: Overall survival rates
timeFrame: Up to 5 years
measure: Adverse event (AE)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: BeiJing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Guangdong
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangzhou
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University People's Hospital
name: Fan Yang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: