Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06838208

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anhui Cancer Hospital

Hefei, Anhui, 230031, China

Location status: Recruiting

Location contact

Shuanghu Yuan, PhD

CONTACT

[email protected]

0551-62894008

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

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;

Other names: radiotherapy

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shuanghu Yuan, PhD

CONTACT

[email protected]

0551-62894008

Sponsors and collaborators

Lead sponsor

Anhui Provincial Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 20, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.