Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07109401

Perioperative Immunotherapy for Resectable Limited-Stage SCLC

Led by Fudan University · Updated on 2025-08-07

37

Participants Needed

1

Research Sites

200 weeks

Total Duration

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AI-Summary

What this Trial Is About

For limited-stage small cell lung cancer (SCLC), surgical treatment is recommended for patients with T1-2N0M0 (I-IIA) by guidelines. However, whether perioperative immunotherapy extends radical surgery to stage IIB-IIIB patients with improved survival remains elusive. This is a phase II, single-arm study to evaluate the efficacy and safety of neoadjuvant Tislelizumab + chemotherapy (Cisplatin/Carboplatin + Etoposide) followed by radical surgery and adjuvant Tislelizumab ± chemotherapy for patients with limited-stage SCLC.

CONDITIONS

Official Title

Perioperative Immunotherapy for Resectable Limited-Stage SCLC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide written informed consent and agree to study requirements
  • Aged 18 to 75 years at consent
  • Diagnosed with small cell lung cancer confirmed by pathology
  • Limited-stage disease (stage IIB-IIIB) assessed by bronchoscopy, PET-CT, EBUS, mediastinoscopy, or biopsy, and judged resectable with curative intent
  • TNM staging includes T3-4 (N0 only) or N1-2 (any T) with no distant metastasis (M0), with specific tumor size and location limits
  • No prior radiotherapy, chemotherapy, immunotherapy, surgery, or systemic treatments
  • ECOG performance status of 0 or 1
  • Expected survival over 3 months
  • Adequate bone marrow and organ function within 30 days before enrollment to receive platinum-based chemotherapy
  • No contraindications for immunotherapy
Not Eligible

You will not qualify if you...

  • Tumor tissue shows non-small cell lung cancer
  • Presence of active or inactive brain metastases
  • History or presence of interstitial lung disease or suspicion of such on imaging
  • Use of systemic corticosteroids within 14 days before first study drug dose
  • Prior radiotherapy, chemotherapy, immunotherapy, surgery, or systemic treatment
  • Active malignancy within 2 years before enrollment
  • Pregnant, breastfeeding, or planning pregnancy during the study
  • Uncontrolled or significant heart disease at enrollment
  • Active or past autoimmune or inflammatory diseases
  • History of active primary immunodeficiency disorders
  • Active infections
  • Active bleeding disorders within 6 months before study drug administration
  • Non-healing wounds, active ulcers, or fractures
  • Any condition making participation unsuitable as judged by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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Research Team

H

Haiquan Chen, MD, Ph.D.

CONTACT

F

Fangqiu Fu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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