Floatz Rating
B63/100
Confidence
Indicative
Sponsor
Qiming Wang
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
66High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07354061CT.gov Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC) | — | Recruiting | — | — | — |
NCT07235306CT.gov Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC | — | Not Yet Recruiting | — | — | — |
NCT06955325CT.gov Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations | — | Not Yet Recruiting | — | — | — |
NCT06772610CT.gov The Efficacy and Safety of Ensartinib As Adjuvant Therapy in Stage I ALK-positive NSCLC Patients with High Risk Factors | — | Not Yet Recruiting | — | — | — |
NCT06785584CT.gov 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 | — | Not Yet Recruiting | — | — | — |
NCT06780839CT.gov Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD | — | Not Yet Recruiting | — | — | — |
NCT06779539CT.gov Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer | — | Not Yet Recruiting | — | — | — |
NCT05380024CT.gov A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Non-Small Cell Lung Cancer | — | Unknown | — | — | — |
NCT05491811CT.gov Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation | — | Active Not Recruiting | — | — | — |
NCT05341583CT.gov Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer | — | Recruiting | — | — | — |
Show 17 more trialsShow fewer
NCT05498064CT.gov A Real World Study of Ensartinib in Advanced ALK-positive NSCLC | — | Recruiting | — | — | — |
NCT05241028CT.gov Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer | — | Recruiting | — | — | — |
NCT05186506CT.gov A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer | — | Not Yet Recruiting | — | — | — |
NCT05178511CT.gov Ensatinib Treat Second-generation ALK-TKI Resistance After Second-generation ALK-TKI Resistance | — | Unknown | — | — | — |
NCT05132218CT.gov Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer | — | Unknown | — | — | — |
NCT04837716CT.gov Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer | — | Active Not Recruiting | — | — | — |
NCT03737994CT.gov Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer | — | Terminated | — | — | — |
NCT03753685CT.gov X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases | — | Active Not Recruiting | — | — | — |
NCT04415320CT.gov X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases | — | Unknown | — | — | — |
NCT03804541CT.gov The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human | — | Unknown | — | — | — |
NCT03574402CT.gov Phase II Umbrella Study Directed by Next Generation Sequencing | — | Unknown | — | — | — |
NCT03215693CT.gov X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib | — | Unknown | — | — | — |
NCT02898116CT.gov Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer | — | Completed | — | — | — |
NCT02959619CT.gov Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK | — | Completed | — | — | — |
NCT02767804CT.gov eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients | — | Active Not Recruiting | — | — | — |
NCT01625234CT.gov Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer | — | Completed | — | — | — |
NCT04146571CT.gov Expanded Access to Ensartinib for Participants With ALK+ NSCLC | — | Available | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Non-Small Cell Lung Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Ensartinib (this asset) | Qiming Wang | Approved | B · 63 |
| Necitumumab | Jonsson Comprehensive Cancer Center | P3 | BBB |
| Glumetinib | Shanghai JMT-Bio Inc. | P3 | BBB |
| Veliparib | AbbVie | P3 | BBB |
| d-0316 | Betta Pharmaceuticals Co., Ltd. | P2/3 | BBB |
| Icotinib | The First Affiliated Hospital of Guangzhou Medical University | P4 | BBB |
| Zoledronate | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | P4 | BBB |
| Onartuzumab | Hoffmann-La Roche | P3 | BBB |
| Avitinib | Hangzhou ACEA Pharmaceutical Research Co., Ltd. | P3 | BBB |
+42 more in the Non-Small Cell Lung Carcinoma cohort
Other indications for Ensartinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Langerhans Cell Histiocytosis | — | P2 | CCC · 53 |
| Non-Hodgkin Lymphoma | — | P2 | CCC · 53 |
| Rhabdomyosarcoma | — | P2 | CCC · 53 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Ensartinib in Non-Small Cell Lung Carcinoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/ensartinib-non-small-cell-lung-carcinoma
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