Firmonertinib versus placebo as additional treatment after surgery for stage IB–IIIB non‑small cell lung cancer with uncommon EGFR mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a global, phase 3, double‑blind, randomized trial that will enroll about 338 participants who have undergone complete (R0) resection for stage IB–IIIB non‑small cell lung cancer with documented uncommon EGFR mutations. Participants are randomized 1:1 to receive firmonertinib 240 mg once daily or matching placebo in 21‑day cycles and will be treated until unacceptable toxicity, withdrawal, recurrence, or other prespecified stopping rules. Eligibility requires confirmed non‑squamous NSCLC, appropriate pathologic staging, and documented uncommon EGFR alterations by a validated NGS or PCR assay, and completion of adjuvant chemotherapy if given. The study will monitor safety and efficacy outcomes related to recurrence and treatment tolerability over the follow‑up period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangdong, Guangzhou, China Recruiting

Study contacts

• Principal investigator: Li Zhang, Master — Sun Yat-Sen University Cancer Center
• Study coordinator: Li Zhang, Master
• Email: Zhangli6@mall.sysu.edu.cn
• Phone: 020-87342288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.