Efficacy and Safety of Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in the First-line Treatment of Extensive Small Cell Lung Cancer: a Prospective, Multicenter, Phase II Clinical Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Age≥18 years old, male or female, signed Informed Consent Form (ICF);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Histologically or cytologically confirmed ES-SCLC;
• No prior systemic treatment for ES-SCLC;
• At least one measurable (RECIST 1.1) chest lesion capable of 15Gy/5f irradiation;
• Adequate hematologic and end organ function;
Locations
Other Locations
China
Anhui Cancer Hospital
RECRUITING
Hefei
Contact Information
Primary
Shuanghu Yuan, PhD
yuanshuanghu@sina.com
0551-62894008
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2028-04-01
Participants
Target number of participants: 56
Treatments
Experimental: Tislelizumab plus chemo and radiotherapy
Experimental treatment~1. Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide~ • Tislelizumab (200 mg IV Q3W) in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 IV Q3W) for 4 cycles. Then maintenance consists of Tislelizumab Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent，up to 2 years.~2. Radiotherapy:~ * Induction therapy stage LDRT: lung lesions, 15Gy/5f;~ * Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f；~Control group: This study refers to the Phase III RATIONALE-312 study, the reported median PFS was 4.7 months in patients treated with Tislelizumab combined with chemotherapy. This regimen has been recommened as 1L treatment for ES-SCLC in the CSCO guidelines.
Related Therapeutic Areas
Sponsors
Leads: Anhui Provincial Cancer Hospital