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NCT05271916
First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations
Phase 1, PHASE2 trial testing Dacomitinib+Anlotinib in Non-Small Cell Lung Cancer (NSCLC) in 140 participants. Currently enrolling.
1 January 2025
Quick facts
| Lead sponsor | Shanghai Chest Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 13 October 2022 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 May 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Dacomitinib+Anlotinib — full drug profile →
- Dacomitinib (Dacomitinib) — full drug profile →
Conditions studied
- Non-Small Cell Lung Cancer (NSCLC) — all drugs for Non-Small Cell Lung Cancer (NSCLC) →
Sponsor
Shanghai Chest Hospital
Who can join
Adults 18 to 75, any sex, with Non-Small Cell Lung Cancer (NSCLC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, open label, Phase I/IIB study investigating the efficacy and safety of treatment with dacomitinib plus anlotinib as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) 21-L858R mutations. This study comprises two parts: 1. A dose escalation Phase I study to determine the recommended phase II dose. 2. a multi-center, open label, randomized controlled, Phase IIB study.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
New Generations of Tyrosine Kinase Inhibitors in Treating NSCLC with Oncogene Addiction: Strengths and Limitations.
Attili I, Corvaja C, Spitaleri G, Del Signore E, et al · · 2023 · cited 32× · PMID 37894445 · DOI 10.3390/cancers15205079
Verify or expand the search:
- PubMed search for NCT05271916
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non-Small Cell Lung Cancer (NSCLC)
Currently open trials in the same condition.
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- NCT07410494 — Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07510724 — Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab · recruiting
- NCT06710132 — Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) · Phase 1, PHASE2 · recruiting
- NCT06558799 — LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic · Phase 2 · active not recruiting
Other Shanghai Chest Hospital trials
Trials by the same sponsor.
- NCT07515027 — Electroacupuncture Plus 5-HT3 Receptor Inhibitor for PONV Prevention in High-Risk Patients Undergoing Thoracoscopic Lung · NA · recruiting
- NCT07479628 — Neoadjuvant Adebrelimab Plus CRT for Locally Advanced Thymic Carcinoma · Phase 2 · not yet recruiting
- 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 NCT05271916 (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: 19 April 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/NCT05271916.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing