This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We design this trial to evaluate the safety and efficacy of Serplulimab plus chemotherapy in SCLC transformed from EGFR-mutated NSCLC after treatment.
Participants with EGFR-mutant NSCLC who were transformed into SCLC after treatment and did not undergo systemic anticancer therapy after transformation will be divided into three cohorts. We plan to enroll 36 patients in the first cohort, and 18 patients in the second cohort. Participants in cohort 1 and cohort 2 will undertake a combination chemotherapy regimen, comprised of serplulimab (300mg), etoposide (100 mg/m2), and carboplatin (AUC 5 mg/mL/min, up to 750mg). These agents will be administered intravenously in 3-week intervals over a span of 4 to 6 cycles. Participants in cohort 3 will be treated with the clinical routine treatment recommended by the investigator.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
serplulimab 300mg, d1, q3w, iv. etoposide 100 mg/m2, d1-3, q3w, iv. carboplatin AUC 5 (up to 750mg), d1, q3w, iv.
the treatment recommended by the investigator
Guangdong Provincial Perople's Hospital
Guangzhou, Guangdong, China
RECRUITINGProgression free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).
Time frame: From date of first dosing to first documented progression or death from any cause, whichever came first, assessed up to 2 years.
Objective Response Rate
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Time frame: Up to 2 years
Overall survival (OS)
OS is the time from the date of first dosing date to death due to any cause.
Time frame: Up to approximately 2 years
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