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

NCT06838208 | Recruiting Phase 2

• 2 other identifiers: PRAD1CRTOG2501
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  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)

  Baseline until PD or death, whichever occurs first or up to approximately 23 months

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months

• Duration Of Response (DOR)

  Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months

• Disease Control Rate (DCR)

  up to approximately 23 months

• 6-moth/1-year Progression Free Survival (PFS) Rate

  up to approximately 23 months

• 1-year Overall Survival (OS) rate

  up to approximately 23 months

Study Arms (1)

Tislelizumab plus chemo and radiotherapy

EXPERIMENTAL

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.

Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide

Interventions

Tislelizumab, Carboplatin /Cisplatin, Etoposide DRUG

Induction therapy stage LDRT: lung lesions, 15Gy/5f; Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f；

Also known as: radiotherapy

Tislelizumab plus chemo and radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
• 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;
• Was administered a live vaccine ≤ 4 weeks before treatment;
• Active autoimmune diseases or history of autoimmune diseases that may relapse;
• Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment;
• With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
• 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;
• Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead

Study Sites (1)

Anhui Cancer Hospital

Hefei, Anhui, 230031, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

tislelizumab; Carboplatin; Cisplatin; Etoposide; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Therapeutics

Central Study Contacts

Shuanghu Yuan, PhD

CONTACT

0551-62894008; yuanshuanghu@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-02

Locations

CN (1)