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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
338
Firmonertinib: 240 mg, QD, orally
Placebo: 240 mg, QD, orally
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangdong, Guangzhou, China
RECRUITINGDisease 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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