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Recruiting NCT06838208

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

Phase II Interventional Extensive-stage Small Cell Lung Cancer (ES-SCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tislelizumab, Carboplatin /Cisplatin, Etoposide.
Who it may be relevant to
Registry conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • 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；

Primary outcome measures

  • Progression Free Survival (PFS) [Time frame: Baseline until PD or death, whichever occurs first or up to approximately 23 months]
Secondary outcome measures (6)
  • Objective Response Rate (ORR) [Time frame: 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]
  • Disease Control Rate (DCR) [Time frame: up to approximately 23 months]
  • 6-moth/1-year Progression Free Survival (PFS) Rate [Time frame: up to approximately 23 months]
  • 1-year Overall Survival (OS) rate [Time frame: up to approximately 23 months]
  • Number Of Participants Experiencing Treatment-Emergent Adverse Events [Time frame: up to approximately 23 months]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Anhui Cancer Hospital — Hefei

Identifiers

NCT: NCT06838208 · PRAD1 · CRTOG2501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗