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Recruiting 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）

Phase III Interventional NSCLC Adjuvant Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Firmonertinib, Placebo.
Who it may be relevant to
Registry conditions: NSCLC, Adjuvant Treatment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Interventions

  • Drug Firmonertinib
    Firmonertinib: 240 mg, QD, orally
  • Drug Placebo
    Placebo: 240 mg, QD, orally

Primary outcome measures

  • Disease free survival (DFS) [Time frame: Up to 3 years]
Secondary outcome measures (6)
  • Disease free survival (DFS) [Time frame: Up to 3 years]
  • Disease free survival (DFS) [Time frame: Up to 3 years]
  • Disease free survival rates [Time frame: Up to 5 years]
  • Overall survival (OS) [Time frame: Up to 5 years]
  • Overall survival rates [Time frame: Up to 5 years]
  • Adverse event (AE) [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

  • Sign the Informed Consent Form (ICF).
  • Aged ≥ 18 years old. Participants from Japan/Taiwan aged ≥ 20 years old.
  • Histologically confirmed diagnosis of primary non-small cell lung cancer (NSCLC) of predominantly non-squamous histology.
  • Underwent complete surgical resection of primary lung cancer and systematic lymph node dissection (R0 resection).
  • 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).
  • 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:

  • NSCLC with EGFR Exon 19 deletion or L858R or C797S mutation.
  • Incomplete resection (R1/R2) or segmentectomy or wedge resection only.
  • Prior treatment with any of the following:
  • Prior treatment with any antineoplastic therapy other than standard platinum-based doublet adjuvant chemotherapy.
  • prior treatment with neoadjuvant therapy.
  • Concurrent malignant tumors other than the primary tumor; participants with cancers that can be treated locally and cured may be eligible.
  • Previous ILD (including drug-induced ILD) or active ILD/active radiation pneumonitis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Peking University People's Hospital — Beijing
  • Sun Yat-sen University Cancer Center — Guangdong

Identifiers

NCT: NCT07010419 · FURMO-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗