Tislelizumab Combined with Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC

Phase 2

Not yet recruiting

• Conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC)
• Interventions: Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide

• Registration Number: NCT06838208
• Lead Sponsor: Anhui Provincial Cancer Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-16
• Study First Submitted QC: 2025-02-16
• Last Update Submitted: 2025-02-16
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Study Start: 2025-02-25
• Primary Completion: 2027-03-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Age≥18 years old, male or female, signed Informed Consent Form (ICF);
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
3. Histologically or cytologically confirmed ES-SCLC;
4. No prior systemic treatment for ES-SCLC;
5. At least one measurable (RECIST 1.1) chest lesion capable of 15Gy/5f irradiation;
6. Adequate hematologic and end organ function;

Exclusion Criteria

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
2. Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
3. Was administered a live vaccine ≤ 4 weeks before treatment;
4. Active autoimmune diseases or history of autoimmune diseases that may relapse;
5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment;
6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to treatment, including but not limited to tuberculosis infection;
8. Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tislelizumab plus chemo and radiotherapy	Tislelizumab, Carboplatin /Cisplatin, Etoposide	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. Radiotherapy: * Induction therapy stage LDRT: lung lesions, 15Gy/5f; * Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f；

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Baseline until PD or death, whichever occurs first or up to approximately 23 months	To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide and radiotherapy in the intent to treat (ITT) Analysis Set as measured by investigator assessed progression free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months	To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide +radiotherapy in the ITT Analysis Set as measured by investigator assessed overall response rate (ORR), according to RECIST v1.1
Duration Of Response (DOR)	Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months	To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide+ radiotherapy in the ITT Analysis Set as measured by investigator assessed duration of response (DOR) according to RECIST v1.1
Disease Control Rate (DCR)	up to approximately 23 months	To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide + radiotherapy in the ITT Analysis Set as measured by investigator assessed disease control rate (DCR) according to RECIST v1.1
6-moth/1-year Progression Free Survival (PFS) Rate	up to approximately 23 months	The PFS rate will be defined as the proportion of participants free from PFS events at 6 month and 1st year after the first dose.
1-year Overall Survival (OS) rate	up to approximately 23 months	The OS rate will be defined as the proportion of participants free from OS events at 1st year after the first dose.
Number Of Participants Experiencing Treatment-Emergent Adverse Events	up to approximately 23 months	Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events