Perioperative Immunotherapy for Resectable Limited-Stage SCLC

NCT07109401 | Recruiting Phase 2

• 1 other identifier: ECTOP-1033
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Perioperative Immunotherapy; Limited Stage Lung Small Cell Carcinoma; Resectable Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• One-year Event-free Survival Rate (1-year EFS Rate)

  The proportion of patients who have not experienced an EFS event within 1 year after the first administration of the study drug. EFS (Event-Free Survival) is defined as the time from the first dose of study treatment until the first occurrence of any of the following events: objectively documented disease progression and inability to undergo radical surgery, local recurrence, distant metastasis, or death from any cause (whichever occurs first). EFS is assessed by investigators based on RECIST v1.1 (Response evaluation criteria in solid tumors v1.1) criteria within the radical curative therapy analysis set.

  Up to 12 months

Secondary Outcomes (11)

• Event-free Survival (EFS)

  up to 60 months

• Overall Survival (OS)

  up to 60 months

• Objective Response Rate (ORR)

  Up to 12 months

• Disease Control Rate (DCR)

  Up to 12 months

• Pathological Complete Response (pCR) Rate

  Up to 12 months

Study Arms (1)

Perioperative Tislelizumab combined with Etoposide and Platinum-based Chemotherapy

EXPERIMENTAL

Neoadjuvant therapy: Tislelizumab 200mg, i.v., q3w, 2-4 cycles; Cisplatin 75mg/m2, d1 or Carboplatin AUC5-6, d1 + Etoposide 100mg/m2, d1-3, q3w, 2-4 cycles. Those resectable after neoadjuvant therapy will be treated with radical surgery. Adjuvant therapy: Patients received radical surgery will be treated with Tislelizumab plus platinum-etoposide therapy (the total cycle of perioperative chemotherapy is four), followed by Tislelizumab monotherapy for one year.

Drug: Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)

Interventions

Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide) DRUG

Neoadjuvant therapy: Tislelizumab + Cisplatin or Carboplatin + Etoposide; Adjuvant therapy: Tislelizumab + Cisplatin or Carboplatin + Etoposide (the total cycle of perioperative chemotherapy is four), followed by Tislelizumab monotherapy for one year.

Perioperative Tislelizumab combined with Etoposide and Platinum-based Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent and understand and agree to comply with the study requirements and assessment schedule;
• Aged 18-75 years at the time of signing the informed consent form;
• Pathologically (histologically or cytologically) confirmed diagnosis of small cell lung cancer;
• Limited-stage disease (stage IIB-IIIB according to AJCC 8th edition) assessed by bronchoscopy, PET-CT, endobronchial ultrasound (EBUS), mediastinoscopy, or percutaneous biopsy, deemed resectable with curative intent (R0 resection) by the investigator.
• TNM staging includes T3-4 (N0 only) or N1-2 (any T) and M0, where T4 is limited to tumors \>7 cm in diameter; Patients with tumors invading the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina or having separate tumor nodules in different ipsilateral lobes are excluded. N2 is limited to single station and non-bulky.
• No prior radiotherapy, chemotherapy, immunotherapy, surgery or other systemic treatments;
• ECOG PS score of 0-1;
• Expected survival must be \>3 months;
• Adequate bone marrow reserve and organ function within 30 days prior to enrollment meeting criteria for receiving platinum-based doublet chemotherapy;
• No contraindications for immunotherapy.

You may not qualify if:

• Tumor histopathology indicates non-small cell lung cancer (NSCLC);
• Presence of clinically inactive or active brain metastases;
• Any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), current ILD, or suspicion of such diseases based on imaging during screening;
• Receiving systemic corticosteroid therapy within 14 days prior to the first dose of study drug;
• Previous radiotherapy, chemotherapy, immunotherapy, surgery, or other systemic treatments;
• Any active malignancy within 2 years prior to enrollment;
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
• Uncontrolled or significant cardiovascular disease at the time of enrollment;
• Active or previously recorded autoimmune or inflammatory diseases before enrollment;
• History of active primary immunodeficiency disorders;
• Presence of active infections;
• Active bleeding disorders within ≤6 months prior to administration of the study drug, including gastrointestinal bleeding evidenced by hematemesis, severe hemoptysis, or melena;
• Non-healing wounds, active peptic ulcers, or fractures;
• Any condition that the investigator deems makes the patient unsuitable for participation in the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Interventions

tislelizumab; Cisplatin; Carboplatin; Etoposide

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Haiquan Chen, MD, Ph.D.

CONTACT

+86-18121299888; hqchen1@yahoo.com

Fangqiu Fu, MD

CONTACT

+86-18918768205; fufangqiu12@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director in the Department of Thoracic Surgery, FUSCC

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 7, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)