Tislelizumab plus chemotherapy before and after surgery for resectable limited-stage small cell lung cancer

Perioperative Tislelizumab for Resectable Small Cell Lung Cancer in Stage IIB-IIIB: A Phase 2 Trial

This trial will try giving the immunotherapy drug tislelizumab with platinum‑etoposide chemotherapy before and after surgery to see if it helps adults with resectable limited-stage (IIB–IIIB) small cell lung cancer live longer or lower the chance of recurrence.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, Tislelizumab
• Locations: 1 site (Shanghai)
• Trial ID: NCT07109401 on ClinicalTrials.gov

What this trial studies

This single-arm phase II trial gives neoadjuvant tislelizumab combined with cisplatin or carboplatin plus etoposide, followed by radical (R0) surgical resection and adjuvant tislelizumab with or without chemotherapy for patients with resectable limited-stage SCLC (AJCC 8th IIB–IIIB). Eligible patients will undergo staging with imaging and invasive sampling to confirm resectability and then receive combined immunochemotherapy prior to surgery. The study will track surgical feasibility, pathological response rates, safety and adverse events, and clinical outcomes such as progression-free and overall survival. Results will help clarify whether perioperative PD-1 blockade can safely extend curative surgical approaches to a broader group of limited-stage SCLC patients.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with pathologically confirmed small cell lung cancer staged IIB–IIIB (AJCC 8th) who are judged resectable with R0 intent, have not had prior chemotherapy or radiotherapy, and can tolerate combined immunotherapy, chemotherapy, and surgery.

Not a fit: Patients with unresectable or metastatic disease, bulky or multi-station N2 involvement, tumor invasion of major thoracic structures, prior chemo/radiotherapy, poor surgical fitness, or those outside the 18–75 age range are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could allow more patients with limited-stage SCLC to receive curative surgery and improve disease-free and overall survival.

How similar studies have performed: Chemo‑immunotherapy has improved outcomes in extensive‑stage SCLC and perioperative immunotherapy has shown promise in non‑small cell lung cancer, but using neoadjuvant and adjuvant PD‑1 blockade specifically for resectable limited‑stage SCLC is relatively novel with limited prior data.

Eligibility criteria

Inclusion Criteria:

1. Able to provide written informed consent and understand and agree to comply with the study requirements and assessment schedule;
2. Aged 18-75 years at the time of signing the informed consent form;
3. Pathologically (histologically or cytologically) confirmed diagnosis of small cell lung cancer;
4. 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.
5. No prior radiotherapy, chemotherapy, immunotherapy, surgery or other systemic treatments;
6. ECOG PS score of 0-1;
7. Expected survival must be \>3 months;
8. Adequate bone marrow reserve and organ function within 30 days prior to enrollment meeting criteria for receiving platinum-based doublet chemotherapy;
9. No contraindications for immunotherapy.

Exclusion Criteria:

1. Tumor histopathology indicates non-small cell lung cancer (NSCLC);
2. Presence of clinically inactive or active brain metastases;
3. 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;
4. Receiving systemic corticosteroid therapy within 14 days prior to the first dose of study drug;
5. Previous radiotherapy, chemotherapy, immunotherapy, surgery, or other systemic treatments;
6. Any active malignancy within 2 years prior to enrollment;
7. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
8. Uncontrolled or significant cardiovascular disease at the time of enrollment;
9. Active or previously recorded autoimmune or inflammatory diseases before enrollment;
10. History of active primary immunodeficiency disorders;
11. Presence of active infections;
12. Active bleeding disorders within ≤6 months prior to administration of the study drug, including gastrointestinal bleeding evidenced by hematemesis, severe hemoptysis, or melena;
13. Non-healing wounds, active peptic ulcers, or fractures;
14. Any condition that the investigator deems makes the patient unsuitable for participation in the study.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Haiquan Chen, MD, Ph.D.

Conditions: Perioperative Immunotherapy, Limited Stage Lung Small Cell Carcinoma, Resectable Small Cell Lung Cancer