Last reviewed · How we verify
NCT06954246
A Phase 3, Multicenter, Randomized, Open-label Study of MHB088C for Injection Versus Treatment of Physician's Choice (TPC) in Comparing the Efficacy and Safety in Subjects With Relapsed Small Cell Lung Cancer (SCLC)
Phase 3 trial testing MHB088C for Injection in Small Cell Lung Cancer Extensive Stage in 450 participants. Currently enrolling.
1 May 2027
Quick facts
| Lead sponsor | Qilu Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 450 |
| Start date | 4 June 2025 |
| Primary completion | 1 May 2027 |
| Estimated completion | 1 April 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- MHB088C for Injection
- Topotecan (topotecan) — full drug profile →
- Irinotecan (irinotecan) — full drug profile →
- Paclitaxel — full drug profile →
Conditions studied
- Small Cell Lung Cancer Extensive Stage — all drugs for Small Cell Lung Cancer Extensive Stage →
Sponsor
Qilu Pharmaceutical Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Small Cell Lung Cancer Extensive Stage. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Overall Survival
Time frame: From the date of randomization to the date of death due to any cause, up to approximately 5 years
Sponsor's own description
This study was designed to compare the efficacy and safety of MHB088C for Injection with treatment of physician's choice (TPC) in participants with relapsed small cell lung cancer (SCLC).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunotherapy for small cell lung cancer: current challenges and prospects.
Zhong J, Jie G, Qin H, Li H, et al · · 2025 · cited 2× · PMID 41194225 · DOI 10.1186/s40164-025-00720-w -
Antibody-drug conjugates in cancer therapy: current advances and prospects for breakthroughs.
Wu D, Yang K, He R, Yin R, et al · · 2025 · cited 2× · PMID 41133214 · DOI 10.3389/fcell.2025.1669592
Verify or expand the search:
- PubMed search for NCT06954246
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MHB088C for Injection
Trials testing the same drug.
- NCT05652855 — Study of MHB088C in Participants With Advanced or Metastatic Solid Tumors · Phase 1, PHASE2 · not yet recruiting
Other recruiting trials for Small Cell Lung Cancer Extensive Stage
Currently open trials in the same condition.
- NCT07227597 — A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6 · Phase 1, PHASE2 · recruiting
- NCT07139990 — Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM) · Phase 1 · recruiting
- NCT06348797 — Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC · Phase 1 · recruiting
- NCT06739928 — Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC · Phase 2 · recruiting
- NCT06429696 — PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer · Phase 2 · recruiting
Other Qilu Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07511647 — A Phase 3 Clinical Study of QL2106 Injection · Phase 3 · not yet recruiting
- NCT07467629 — QLS5212 for Participants With Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07455006 — Safety and Efficacy Study of QL0911 to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients · Phase 3 · not yet recruiting
- NCT07463573 — QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma · Phase 3 · not yet recruiting
- NCT07444086 — QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia · Phase 3 · 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 NCT06954246 (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 Qilu Pharmaceutical Co., Ltd.
- Last refreshed: 15 June 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/NCT06954246.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing