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

September 18, 2025 updated by: Shuanghu Yuan, Anhui Provincial Cancer Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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；
Other Names:
  • radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Baseline until PD or death, whichever occurs first or up to approximately 23 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide +radiotherapy in the ITT Analysis Set as measured by investigator assessed overall response rate (ORR), according to RECIST v1.1
Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months
Duration Of Response (DOR)
Time Frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide+ radiotherapy in the ITT Analysis Set as measured by investigator assessed duration of response (DOR) according to RECIST v1.1
Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months
Disease Control Rate (DCR)
Time Frame: up to approximately 23 months
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide + radiotherapy in the ITT Analysis Set as measured by investigator assessed disease control rate (DCR) according to RECIST v1.1
up to approximately 23 months
6-moth/1-year Progression Free Survival (PFS) Rate
Time Frame: up to approximately 23 months
The PFS rate will be defined as the proportion of participants free from PFS events at 6 month and 1st year after the first dose.
up to approximately 23 months
1-year Overall Survival (OS) rate
Time Frame: up to approximately 23 months
The OS rate will be defined as the proportion of participants free from OS events at 1st year after the first dose.
up to approximately 23 months
Number Of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame: up to approximately 23 months
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events
up to approximately 23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 16, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRAD1
  • CRTOG2501 (Other Identifier: CRTOG)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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