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NCT06785584
Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study
Phase 4 trial testing Ensartinib in ALK-positive Advanced NSCLC in 30 participants. Not yet recruiting.
1 December 2025
Quick facts
| Lead sponsor | Fujian Medical University Union Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 February 2025 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Ensartinib (ENSARTINIB) — full drug profile →
Conditions studied
- ALK-positive Advanced NSCLC — all drugs for ALK-positive Advanced NSCLC →
- ALK-positive Non-small Cell Lung Cancer (NSCLC) — all drugs for ALK-positive Non-small Cell Lung Cancer (NSCLC) →
- MPR — all drugs for MPR →
- Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →
Sponsor
Fujian Medical University Union Hospital
Who can join
18 and older, any sex, with ALK-positive Advanced NSCLC or ALK-positive Non-small Cell Lung Cancer (NSCLC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
According to the Global Cancer Statistics 2022 report, lung cancer is the most common type of cancer (12.4% of the total) and the leading cause of cancer deaths (18.7% of total cancer deaths). According to the pathological classification of patients, lung cancer is divided into small cell lung cancer and non-small cell lung cancer, of which non-small cell lung cancer (NSCLC) accounts for 80-85% of all lung cancer. Surgery is the preferred treatment for patients with early-stage lung cancer, according to the 2024 CSCO Guidelines. However, most patients have the possibility of recurrence and metastasis after surgery. The 5-year survival rate of patients with stage IA NSCLC is 80%-90%, but the 5-year survival rate of patients with stage ⅢB NSCLC drops to 40%. Neoadjuvant therapy has become an important part of the treatment of non-small cell lung cancer (NSCLC) in order to prolong the survival of patients. In the past few years, many driver genes of NSCLC have been identified, and anaplastic lymphoma kinase (ALK) is one of them. ALK was first identified in anaplastic large cell lymphoma (ALCL). Studies at home and abroad have shown that ALK-rearranged (positive)NSCLC accounts for about 3%-7% of all NSCLC patients. Many studies have suggested that ALK-TKI is clinically feasible as a neoadjuvant therapy for ALK positve patients with locally advanced NSCLC. The investigators designed this study to explore the efficacy of enshatinib neoadjuvant therapy in patients with stage IIA to III ALK-positive lung adenocarcinoma
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Neoadjuvant, Adjuvant and Perioperative Treatment in Early-Stage Non-Small Cell Lung Cancer (NSCLC) with Actionable Genomic Alterations: Current Landscape and Future Perspectives.
Koutoukoglou P, Mountzios G. · · 2026 · PMID 41681965 · DOI 10.3390/cancers18030493
Verify or expand the search:
- PubMed search for NCT06785584
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ensartinib
Trials testing the same drug.
- NCT07448116 — Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors. · Phase 1, PHASE2 · recruiting
- NCT06762327 — Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer · Phase 2 · not yet recruiting
- NCT06780839 — Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD · Phase 2 · not yet recruiting
- NCT06779539 — Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
- NCT06563999 — Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. · Phase 2 · recruiting
Other Fujian Medical University Union Hospital trials
Trials by the same sponsor.
- NCT07406815 — The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Inva · Phase 3 · not yet recruiting
- NCT07444983 — Rezvilutamide for High-Risk Prostate Cancer After Surgery · NA · not yet recruiting
- NCT07493070 — Ultra-stable Iodized Oil-Chemo Embolization Seq Thermal Ablation in Early Liver Ca · NA · active not recruiting
- NCT07389889 — Percutaneous Robotic Navigation Microwave Ablation Versus CT-guided Microwave Ablation in the Treatment of Pulmonary Nod · NA · not yet recruiting
- NCT07303231 — The Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esoph · 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 NCT06785584 (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 Fujian Medical University Union Hospital
- Last refreshed: 21 January 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/NCT06785584.
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