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NCT06375109: NeoSCLC-001
PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC
Phase 2 trial testing Tislelizumab in Limited-stage Small-cell Lung Cancer in 60 participants. Not yet recruiting.
15 April 2027
Quick facts
| Lead sponsor | Beijing Chest Hospital, Capital Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 16 April 2024 |
| Primary completion | 15 April 2027 |
| Estimated completion | 15 April 2029 |
Drugs / interventions tested
- Tislelizumab (TISLELIZUMAB) — full drug profile →
- Carboplatin injection — full drug profile →
- Cisplatin injection — full drug profile →
- Etoposide injection
Conditions studied
- Limited-stage Small-cell Lung Cancer — all drugs for Limited-stage Small-cell Lung Cancer →
Sponsor
Beijing Chest Hospital, Capital Medical University
Who can join
Adults 18 to 75, any sex, with Limited-stage Small-cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy and safety of neoadjuvant chemotherapy with or without PD-L1/PD-1 inhibitors in surgically limited-stage small-cell lung cancer.
Shi L, Li H, Guo L, Tang J, et al · · 2025 · PMID 41132956 · DOI 10.21037/tlcr-2025-438
Verify or expand the search:
- PubMed search for NCT06375109
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tislelizumab
Trials testing the same drug.
- NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer · Phase 2 · not yet recruiting
- NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
- NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
- NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas · Phase 2 · not yet recruiting
- NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin · Phase 2 · not yet recruiting
Other recruiting trials for Limited-stage Small-cell Lung Cancer
Currently open trials in the same condition.
- NCT07242547 — Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients · Phase 2 · recruiting
Other Beijing Chest Hospital, Capital Medical University trials
Trials by the same sponsor.
- NCT06467617 — Adebrelimab Plus Chemo and Recaticimab in Perioperative Treatment of Resectable NSCLC · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06375109 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Chest Hospital, Capital Medical University
- Last refreshed: 19 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06375109.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing