Last reviewed · How we verify
NCT07289048
A Prospective, Single-Arm, Exploratory Study of IBI363 in ES-SCLC Patients After Immunotherapy Progression
Phase 2 trial testing IBI363（PD-1/IL-2a-bias） in SCLC,Extensive Stage in 35 participants. Not yet recruiting.
30 December 2027
Quick facts
| Lead sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 20 December 2025 |
| Primary completion | 30 December 2027 |
| Estimated completion | 30 December 2028 |
Drugs / interventions tested
- IBI363（PD-1/IL-2a-bias） — full drug profile →
Conditions studied
- SCLC,Extensive Stage — all drugs for SCLC,Extensive Stage →
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Who can join
Adults 18 to 75, any sex, with SCLC,Extensive Stage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a prospective, single-arm, exploratory clinical trial designed to evaluate the efficacy and safety of IBI363 in patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed after at least two prior lines of standard therapy, including PD-1/PD-L1 inhibitor-based immunotherapy. A total of 35 patients were enrolled. The primary endpoint is the objective response rate (ORR), as assessed by investigators according to RECIST 1.1 criteria. Following a screening period of up to 28 days, patients will receive IBI363 treatment until disease progression, onset of intolerable toxicity, withdrawal of informed consent, completion of 24 months of therapy, discontinuation due to other protocol-specified reasons, or early termination of the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07289048
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for SCLC,Extensive Stage
Currently open trials in the same condition.
- NCT07141264 — Adebrelimab Combine With Etoposide Capsules in ES-SCLC Maintenance Therapy · Phase 2 · recruiting
Other Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials
Trials by the same sponsor.
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- NCT06970262 — FMT for Lung and Associated-organ Rescue Efficacy in ARDS Patients · NA · recruiting
- NCT07509424 — Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Lo · Phase 2 · 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 NCT07289048 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Last refreshed: 17 December 2025
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/NCT07289048.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing