PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC
NCT06375109 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-04-19
Summary
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.
Conditions
- Limited-stage Small-cell Lung Cancer
Interventions
- DRUG
-
Tislelizumab
administered via Intravenous (IV) injection
- DRUG
-
Carboplatin injection
administered via IV injection
- DRUG
-
Cisplatin injection
administered via IV injection
- DRUG
-
Etoposide injection
administered via IV injection
Sponsors & Collaborators
-
Beijing Chest Hospital, Capital Medical University
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-16
- Primary Completion
- 2027-04-15
- Completion
- 2029-04-15
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