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NCT06256237
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer : A Phase 2 Trial
Phase 2 trial testing JS004 in Limited Stage Small Cell Lung Cancer in 30 participants. Currently enrolling.
31 January 2027
Quick facts
| Lead sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 April 2024 |
| Primary completion | 31 January 2027 |
| Estimated completion | 31 January 2032 |
| Sites | 1 location across China |
Drugs / interventions tested
- JS004 — full drug profile →
- Toripalimab (TORIPALIMAB) — full drug profile →
- surgery
- Etoposide (etoposide) — full drug profile →
- Platinum (PLATINUM) — full drug profile →
Conditions studied
- Limited Stage Small Cell Lung Cancer — all drugs for Limited Stage Small Cell Lung Cancer →
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Who can join
18 and older, any sex, with Limited Stage Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
For limited-stage small cell lung cancer (SCLC), neoadjuvant chemotherapy plus PD-1 antibody is recommended. However, most patients cannot achieve a complete pathological response (CPR). A new immunotherapeutic strategy is needed to achieve a higher CPR rate. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells\' function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 plus etoposide and platinum Chemotherapy in limited-stage SCLC.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting T cell exhaustion: emerging strategies in non-small cell lung cancer.
Liu X, Xi X, Xu S, Chu H, et al · · 2024 · cited 40× · PMID 39726592 · DOI 10.3389/fimmu.2024.1507501 -
Current and future therapies for small cell lung carcinoma.
Zhai X, Zhang Z, Chen Y, Wu Y, et al · · 2025 · cited 15× · PMID 40170056 · DOI 10.1186/s13045-025-01690-6
Verify or expand the search:
- PubMed search for NCT06256237
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of JS004
Trials testing the same drug.
- NCT06648200 — Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer · Phase 2 · not yet recruiting
- NCT06690697 — Combination of Toripalimab and JS004 Therapy for ccRCC · Phase 2 · recruiting
- NCT06370754 — Newly Emerging Immunotherapy for Pancreatic Cancer Treatment · Phase 1, PHASE2 · not yet recruiting
- NCT05891080 — Neoadjuvant Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy for Resectable or Poten · Phase 2 · not yet recruiting
- NCT05427396 — A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripali · Phase 1 · terminated
Other recruiting trials for Limited Stage Small Cell Lung Cancer
Currently open trials in the same condition.
- NCT06943235 — Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in th · Phase 2 · recruiting
- NCT06117774 — Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) · Phase 3 · recruiting
- NCT05623267 — Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT · Phase 2, PHASE3 · recruiting
- NCT05443646 — Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients · Phase 2 · recruiting
- NCT04829708 — Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cel · Phase 3 · recruiting
Other Shanghai Pulmonary Hospital, Shanghai, China trials
Trials by the same sponsor.
- NCT07469488 — A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-M · Phase 4 · not yet recruiting
- NCT07494591 — TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery · NA · not yet recruiting
- NCT07517640 — Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial · Phase 2 · not yet recruiting
- NCT07393438 — Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS) · Phase 2 · not yet recruiting
- NCT07375979 — A Multi-modal Integrating Imaging and Cell-free DNA Methylation in Lung Cancer Early Detection (CMe-Lung): a Multi-cente · not yet 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 NCT06256237 (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 Shanghai Pulmonary Hospital, Shanghai, China
- Last refreshed: 29 May 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/NCT06256237.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing