This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
administered via Intravenous (IV) injection
administered via IV injection
administered via IV injection
Pathologic Complete Response (pCR) Rate
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Time frame: Up to 3 months following completion of neoadjuvant treatment
Major Pathologic Response (MPR) Rate
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy.
Time frame: Up to 3 months following completion of neoadjuvant treatment
Event-Free Survival (EFS)
EFS is defined as the time from enrollment until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.
Time frame: up to 5 years
Overall Survival (OS)
OS is defined as the time from enrollment until death from any cause.
Time frame: up to 5 years
Objective response rate (ORR)
The proportion of patients who have had a complete response or partial response (according to RECIST1.1) in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.
Time frame: Up to 1 months following completion of neoadjuvant treatment
Safety: frequency of severe adverse events
The frequency of severe adverse events from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
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administered via IV injection
Time frame: up to 6 months