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

Anhui Provincial Cancer Hospital

Status and phase: Enrolling; Phase 2

Conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Treatments: Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT06838208

CRTOG2501 (Other Identifier)

PRAD1

Details and patient eligibility

About

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

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

56 participants in 1 patient group

Tislelizumab plus chemo and radiotherapy

Experimental group

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.

Treatment:

Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide