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NCT04985851
To Evaluate the Efficacy of Durvalumab + Anlotinib in Terms of OS and PFS.
NA trial testing durvalumab + anlotinib in Extensive-Stage Small-Cell Lung Cancer in 90 participants. Status unknown.
1 June 2024
Quick facts
| Lead sponsor | Shanghai Chest Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 28 September 2021 |
| Primary completion | 1 June 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- durvalumab + anlotinib — full drug profile →
- Durvalumab — full drug profile →
Conditions studied
- Extensive-Stage Small-Cell Lung Cancer — all drugs for Extensive-Stage Small-Cell Lung Cancer →
Sponsor
Shanghai Chest Hospital
Who can join
Adults 18 to 75, any sex, with Extensive-Stage Small-Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, randomised, multicenter, Phase II study. This study is planned to enroll 90 eligible patients to receive durvalumab combined with up to 4 cycles of etoposide and platinum-based chemotherapy (EP). And approximately 64 patients who complete the 4 cycles of durvalumab + EP treatment and don't have progressive diseases (Non-PD patients) will be randomized in a 1:1 ratio to receive maintenance treatment durvalumab + anlotinib (Arm 1) or durvalumab (Arm 2) until confirmed progressive disease. Prophylactic cranial irradiation (PCI) is allowed at the investigators' discretion as per SoC guidance for ES-SCLC. Patients will attend a safety follow up visit 90 days after last dose of durvalumab. Tumor assessments will be performed at Screening with follow-up at Week 6 ±1 week and Week 12 ±1 week from the date of the first cycle treatment, and then every 8 weeks ±1 week until confirmed objective disease progression.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeted Therapies in Small Cell Lung Cancer: From Old Failures to Novel Therapeutic Strategies.
Cani M, Napoli VM, Garbo E, Ferrari G, et al · · 2023 · cited 11× · PMID 37240229 · DOI 10.3390/ijms24108883 -
Rationale and design of a multicenter, randomized phase II trial of durvalumab with or without multitarget tyrosine kinase inhibitor as maintenance treatment in extensive-stage small-cell lung cancer patients (DURABLE study).
Zhang B, Zhong H, Shi C, Gao Z, et al · · 2023 · cited 3× · PMID 37947242 · DOI 10.1111/crj.13715 -
Landscape and Treatment Options of Shapeshifting Small Cell Lung Cancer.
Gu Y, Benavente CA. · · 2024 · cited 2× · PMID 38892831 · DOI 10.3390/jcm13113120 -
Durvalumab plus anlotinib versus durvalumab alone as maintenance treatment in extensive-stage small-cell lung cancer (DURABLE): a multicenter, randomized, phase II trial and biomarker analysis.
Zhang B, Zhong R, Shi C, Chu T, et al · · 2026 · PMID 42185290 · DOI 10.1038/s41467-026-73562-7
Verify or expand the search:
- PubMed search for NCT04985851
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Extensive-Stage Small-Cell Lung Cancer
Currently open trials in the same condition.
- NCT06211036 — Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer ( · Phase 3 · active not recruiting
- NCT05796089 — Chemotherapy and Immunotherapy in Extensive-Stage Small-Cell Lung Cancer With Thoracic Radiotherapy · Phase 2 · active not recruiting
Other Shanghai Chest Hospital trials
Trials by the same sponsor.
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- NCT07528066 — Downstaging and RATS After Neo-Chemo-IO: Impact on Surgical Outcomes in NSCLC · recruiting
- NCT07331727 — Epicardial Adipose Tissue-Targeted DApagliflozin for Reducing Electrical Remodeling in Atrial Fibrillation · NA · not yet recruiting
- NCT07320768 — Renal Denervation Combined With Pulsed Field Ablation to Prevent Blanking-Period Recurrence in Persistent Atrial Fibrill · 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 NCT04985851 (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 Chest Hospital
- Last refreshed: 1 December 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/NCT04985851.
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