Clinical trial NCT06838208: Tislelizumab Combined with Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Lead sponsor: Anhui Provincial Cancer Hospital
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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;

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline until PD or death, whichever occurs first or up to approximately 23 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months
measure: Duration Of Response (DOR)
timeFrame: Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months
measure: Disease Control Rate (DCR)
timeFrame: up to approximately 23 months
measure: 6-moth/1-year Progression Free Survival (PFS) Rate
timeFrame: up to approximately 23 months
measure: 1-year Overall Survival (OS) rate
timeFrame: up to approximately 23 months
measure: Number Of Participants Experiencing Treatment-Emergent Adverse Events
timeFrame: up to approximately 23 months
Other outcomes:
Locations:
Study officials:
References: