A Phase 3 interventional study of Firmonertinib and Placebo in NSCLC and Adjuvant Treatment, sponsored by Allist Pharmaceuticals, Inc.. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Allist Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
A participant would be excluded from the study if he/she meets any of the following:
Prior treatment with any of the following:
Firmonertinib: 240 mg, QD, orally
Drug: Firmonertinib
Placebo: 240 mg, QD, orally
Drug: Placebo
Firmonertinib: 240 mg, QD, orally
Placebo: 240 mg, QD, orally
Disease free survival (DFS)
DFS as assessed by the investigator in Stage II- IIIB. DFS defined as the time from the date of randomization to the first observation of disease recurrence (by pathological diagnosis or imaging) or death caused by any reason, whichever occurs first.
Time frame: Up to 3 years
Disease free survival (DFS)
DFS as assessed by the blinded independent central review (BICR) in Stage II-IIIB
Time frame: Up to 3 years
Disease free survival (DFS)
DFS as assessed by the investigator in Stage IB-IIIB; DFS as assessed by the BICR in Stage IB-IIIB
Time frame: Up to 3 years
Disease free survival rates
2-, 3-, and 5-year DFS rates as assessed by the investigator and BICR in Stage II-IIIB and in Stage IB-IIIB
Time frame: Up to 5 years
Overall survival (OS)
OS defined as the time from the date of randomization to the date of death due to any cause, in Stage II-IIIB and in Stage IB-IIIB
Time frame: Up to 5 years
Overall survival rates
2-, 3-, and 5-year OS rates in Stage II-IIIB and in Stage IB-IIIB
Time frame: Up to 5 years
Adverse event (AE)
Incidence and severity of AEs, with severity as determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
Time frame: Up to 5 years
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Allist Pharmaceuticals, Inc.