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.
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).
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 antineoplastic therapy other than standard platinum-based doublet adjuvant chemotherapy.
prior treatment with neoadjuvant therapy.
Parallel
Firmonertinib
DrugFirmonertinib: 240 mg, QD, orally
Placebo
DrugPlacebo: 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.
Disease free survival (DFS)
DFS as assessed by the blinded independent central review (BICR) in Stage II-IIIB
Disease free survival (DFS)
DFS as assessed by the investigator in Stage IB-IIIB; DFS as assessed by the BICR in Stage IB-IIIB
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
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
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Allist Pharmaceuticals, Inc.
Lead sponsor
ArriVent BioPharma, Inc.
Collaborator
