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

NCT ID: NCT06838208

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2028-04-01

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tislelizumab plus chemo and radiotherapy

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.

Group Type: EXPERIMENTAL

Tislelizumab, Carboplatin /Cisplatin, Etoposide

Intervention Type: DRUG

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

Interventions

Tislelizumab, Carboplatin /Cisplatin, Etoposide

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

Intervention Type: DRUG

Other Intervention Names

radiotherapy

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shuanghu Yuan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anhui Cancer Hospital

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shuanghu Yuan, PhD

Role: CONTACT

yuanshuanghu@sina.com

0551-62894008

Facility Contacts

Shuanghu Yuan, PhD

Role: primary

yuanshuanghu@sina.com

0551-62894008

Other Identifiers

CRTOG2501

Identifier Type: OTHER

Identifier Source: secondary_id

PRAD1

Identifier Type: -

Identifier Source: org_study_id