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NCT05901584
A Single-arm Multicenter Phase II Clinical Trial of Cadunilumab (Anti-PD-1/CTLA-4) in Combination With or Without Chemotherapy in Second-line Treatment for Patients With Extensive Stage Small Cell Lung Cancer
Phase 2 trial testing Cadonilimab in Immunotherapy in 30 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | Second Affiliated Hospital of Zunyi Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 30 |
| Start date | 1 January 2023 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Cadonilimab — full drug profile →
Conditions studied
- Immunotherapy — all drugs for Immunotherapy →
- Second-line Treatment — all drugs for Second-line Treatment →
Sponsor
Second Affiliated Hospital of Zunyi Medical University
Who can join
Adults 18 to 75, any sex, with Immunotherapy or Second-line Treatment. 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.
-
Progression-free survival,PFS
Time frame: Time Frame: The last subject completes at least 24 weeks of follow-up (or disease progression)
The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST v i I Assessed PFS
Sponsor's own description
This study is a phase II clinical study of Cadonilimab (AK104) combined with or without chemotherapy in the treatment of PD-1 inhibitor-resistant extensive stage small cell lung cancer
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Dual blockade immunotherapy targeting PD-1/PD-L1 and CTLA-4 in lung cancer.
Cheng W, Kang K, Zhao A, Wu Y. · · 2024 · cited 110× · PMID 39068460 · DOI 10.1186/s13045-024-01581-2 -
A Single-Arm Multi-Center Phase II Clinical Trial of Cadonilimab (anti-PD-1/CTLA-4) in Combination with or without Conventional Second-Line Treatment for Patients with Extensive Stage Small Cell Lung Cancer.
Chen C, Chen M, Bai Y, Li Y, et al · · 2024 · cited 8× · PMID 38706247 · DOI 10.1177/15330338241249690 -
The Evolving Scenario of ES-SCLC Management: From Biology to New Cancer Therapeutics.
Trillo Aliaga P, Del Signore E, Fuorivia V, Spitaleri G, et al · · 2024 · cited 5× · PMID 38927637 · DOI 10.3390/genes15060701 -
Next-generation immunotherapy: igniting new hope for lung cancer.
Li MSC, Chan ALS, Mok KKS, Chan LL, et al · · 2024 · cited 3× · PMID 39649017 · DOI 10.1177/17588359241302021 -
The Role of Immune Checkpoint Inhibitors in Cancer Therapy: Mechanism and Therapeutic Advances.
Chen H, Yang H, Guo L, Sun Q. · · 2025 · cited 1× · PMID 41059489 · DOI 10.1002/mco2.70412 -
Expanding the immunotherapy universe in extensive-stage small cell lung cancer: from chemoimmunotherapy backbone to next-wave combinations.
Chi X, Dong Y, Zhu L, Su D, et al · · 2025 · PMID 41415276 · DOI 10.3389/fimmu.2025.1693401
Verify or expand the search:
- PubMed search for NCT05901584
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07243951 — Phase II Clinical Study on the Efficacy and Safety of the Combination of Cadonilimab and Capecitabine in Adjuvant Therap · Phase 2 · not yet recruiting
- NCT06913218 — A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically R · Phase 1 · not yet recruiting
- NCT06940921 — SBRT-LDRT-Cadonilimab for Advanced Gastric, Colorectal and Ovarian Cancers With Peritoneal Metastases · Phase 1, PHASE2 · active not recruiting
- NCT06789848 — Ligufalimab and Cadonilimab in Advanced Liver Cancers · Phase 2 · recruiting
Other recruiting trials for Immunotherapy
Currently open trials in the same condition.
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- NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
- NCT07458529 — Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer · Phase 2 · recruiting
- NCT07436845 — Impact of Emotional Status on Prognosis of Patients With BCLC Stage B/C Hepatocellular Carcinoma Undergoing Hepatic Arte · recruiting
- NCT06671613 — Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer · NA · recruiting
Other Second Affiliated Hospital of Zunyi Medical University trials
Trials by the same sponsor.
- NCT06725225 — Machine Learning for Predicting and Managing Quality of Life in Lung Cancer Immunotherapy Patients · NA · 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 NCT05901584 (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 Second Affiliated Hospital of Zunyi Medical University
- Last refreshed: 14 June 2023
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/NCT05901584.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing