Clinical trial · Interventional
Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC
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
NCT06838208CI-TRIAL-00095725recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive-stage Small Cell Lung Cancer (ES-SCLC) | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab, Carboplatin /Cisplatin, Etoposide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tislelizumab plus chemo and radiotherapy
- description
- 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.
- interventionNames
- Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Baseline until PD or death, whichever occurs first or up to approximately 23 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.