This single-center, prospective study and aims to evaluate the efficacy and safety of limertinib combined with etoposide and carboplatin in EGFR-mutant NSCLC patients who develop small-cell lung cancer transformation following progression on EGFR-TKI therapy.
Signed written informed consent prior to any study-related procedures.
Age ≥ 18 and ≤ 80 years.
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with a sensitizing EGFR mutation (exon 19 deletion or L858R, with or without concurrent mutations).
Prior treatment with EGFR-TKI, with documented disease progression and histologically confirmed small-cell lung cancer (SCLC) transformation.
Histology at initial diagnosis of small-cell lung cancer (SCLC), large-cell carcinoma, or mixed tumor with predominant SCLC, large-cell, or neuroendocrine components.
Prior treatment with a standard SCLC chemotherapy regimen (e.g., carboplatin/etoposide or cisplatin/etoposide) after SCLC transformation.
Symptomatic or unstable brain metastases. Patients with a history of unstable brain metastases must have undergone definitive surgery or radiotherapy, remain clinically stable, and be off corticosteroids for cerebral edema for at least 14 days before enrollment.
Any concurrent malignancy other than basal cell carcinoma of the skin or carcinoma in situ of the cervix. (Patients with a prior malignancy must be disease-free for ≥ 5 years to be eligible.)
Single group
limertinib
Druglimertinib 80 mg
etoposide and carboplatin
Drugetoposide 100 mg/m² IV D1-3 + carboplatin AUC 5-6 IV
Progression-free survival (PFS)
define as first dose to first documented disease progression assessed by investigator or death due to any cause
Objective Response Rate (ORR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
Disease control response (DcR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) , partial response (PR) or stable disease (SD)
Duration of Response (DoR)
To assess duration of response for subjects with CR or PR according to RECIST version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death
Adverse events (AEs)
Number of participants with adverse events (AEs) according to CTCAE 5.0
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