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.
This is a single-center, prospective interventional Phase II study designed to assess the efficacy, safety and mechanism of resistance to limertinib combined with carboplatin and etoposide in EGFR-mutant NSCLC patients who have histologically confirmed small-cell transformation after progression on EGFR-TKI therapy. Thirty patients will receive Limertinib orally once daily (80 mg) plus carboplatin (AUC 5-6, day 1) and etoposide (100 mg/m², days 1-3) every 21 days until disease progression or unacceptable toxicity. Radiographic tumor evaluation will be conducted every 6 weeks per RECIST v1.1. Tumor tissue and blood specimens will be collected at baseline and upon disease progression for next-generation sequencing to elucidate the molecular mechanisms underlying histological transformation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
limertinib 80 mg
etoposide 100 mg/m² IV D1-3 + carboplatin AUC 5-6 IV
Yongchang Zhang
Changsha, Hunan, China
Progression-free survival (PFS)
define as first dose to first documented disease progression assessed by investigator or death due to any cause
Time frame: Time from first subject dose to study completion, or up to 36 month
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)
Time frame: Time from first subject dose to study completion, or up to 36 month
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)
Time frame: Time from first subject dose to study completion, or up to 36 month
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
Time frame: Time from first subject dose to study completion, or up to 36 month
Adverse events (AEs)
Number of participants with adverse events (AEs) according to CTCAE 5.0
Time frame: From first dose to the last dose, up to 24 month
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