marked.bio

ALK TKI (2nd generation) · small molecule

ensartinib

14 active trials across 8 of our biomarkers, targeting ALK. 1 active approval for a biomarker on marked.bio.

Also known as X-396, Ensacove, Gevalka.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
ensartinib
FDA, 2024
locally advanced or metastatic, ALK-positive, ALK-inhibitor-naive FDA approval 18/12/2024 (ALK-inhibitor-naive). Source
EU (EMA)
ALK-positive NSCLC Positive CHMP opinion 17 Sept 2026 (brand Gevalka); European Commission decision pending. CHMP positive opinion 17/09/2026 (ALK+ advanced NSCLC, ALK-inhibitor-naive and post-crizotinib). European Commission decision not yet issued as of the check date. Source
Ensacove, Gevalka 		ALK fusion NSCLC Approved 2024 Under review

eXalt3 vs crizotinib, 143 vs 147 patients
PFS 25.8 months vs 12.7 months, HR 0.56 (0.40-0.79)Response 74% vs 67%

Serious side effects 23%Stopped for side effects 12%Fatal 0.7%

Trial details and side effects
Patients
ALK-positive NSCLC not previously treated with an ALK inhibitor (NCT02767804)
Most common side effects
rash 66%, musculoskeletal pain 36%, constipation 31%, cough 31%, pruritus 30%, nausea 28% (143 patients)
Notes
US label rev. 02/2026.
Source
US label

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
ALK fusion 14 23 Phase 4
ROS1 fusion 2 3 Phase 2
BRAF V600E 1 1 Phase 2
EGFR exon 20 insertion 1 1 Phase 2
KRAS G12C 1 1 Phase 2
MET exon 14 skipping 1 1 Phase 2
NTRK1/2/3 fusion 1 1 Phase 2
RET fusion or mutation 1 1 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of ensartinib.

  1. Xcovery Holdings 1

Trials

14 of 24 trials shown

  1. 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 Phase 4 Fujian Medical University Union Hospital Started 2025Primary completion 2025-12 NCT06785584

    ensartinib FDA

    Alk-positive as determined by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), n…

    ALK fusionALK-positive Advanced NSCLC, ALK-positive Non-small Cell Lung Cancer (NSCLC), MPR, Neoadjuvant Therapy

  2. eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

    Active, not recruiting Phase 3 Xcovery Holdings Started 2016Primary completion 2025-12 NCT02767804

    ensartinib FDAcrizotinib FDA EU

    …age IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive by an FDA-approved assay performed centrally.

    ALK fusionNon-small Cell Lung Cancer

  3. Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC)

    Recruiting Phase 1/2 Tang-Du Hospital Started 2026Primary completion 2028-03 NCT07354061

    ensartinib FDA

    Confirmed ALK fusion mutation by detection methods recommended by NCCN guidelines.

    ALK fusionNSCLC (Non-small Cell Lung Cancer)

  4. Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer

    Not yet recruiting Phase 2 Nanjing First Hospital, Nanjing Medical University Started 2025Primary completion 2026-12 NCT06762327

    ensartinib

    Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer

    MET exon 14 skippingALK fusionSolid Tumors

  5. Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC

    Not yet recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai Started 2025Primary completion 2031-01 NCT07235306

    ensartinib FDA

    ALK mutations assessed by FISH, IHC, or NGS

    ALK fusionNSCLC Stage III, Ensartinib, Chemoradiotherapy, ALK

  6. Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD

    Not yet recruiting Phase 2 Peking University Cancer Hospital & Institute Started 2025Primary completion 2029-01 NCT06780839

    ensartinib FDA

    Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD

    ALK fusionNSCLC, Stage I, II, IIIA, IIIB

  7. Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 West China Hospital Started 2025Primary completion 2028-06 NCT06779539

    ensartinib FDA

    Patients confirmed as ALK fusion positive by RBK (NGS) test.

    ALK fusionNon-Small Cell Lung Cancer

  8. Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

    Recruiting Phase 2 Sun Yat-sen University Started 2024Primary completion 2027-11 NCT06563999

    sunvozertinib FDAcrizotinibpralsetiniblarotrectinibsavolitinibpyrotinibdabrafenibtrametinibglecirasibensartinib

    Subjects should have a rare mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK …

    EGFR exon 20 insertionKRAS G12CBRAF V600EALK fusionROS1 fusionRET fusion or mutationNTRK1/2/3 fusionLung Cancer Stage III, Mutation

  9. Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer

    Recruiting Phase 2 Hebei Medical University Fourth Hospital Started 2022Primary completion 2027-02 NCT05241028

    ensartinib FDA

    Completely resected pathological stage IB-IIIA NSCLC with ALK-fusion positive (confirmed by FISH, IHC or NGS).

    ALK fusionStatus may be outdated, last updated 2023-10-10Non-small Cell Lung Cancer

  10. 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 Phase 2 Sichuan University Started 2022Primary completion 2025-12 NCT05186506

    ensartinib FDAchemotherapy

    Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS

    ALK fusionStatus may be outdated, last updated 2022-01-11ALK Fusion Protein Expression, Adjuvant Therapy, Non-Small Cell Lung Cancer

  11. Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation

    Active, not recruiting Phase 2 Sun Yat-sen University Started 2022Primary completion 2024-08 NCT05491811

    ensartinib FDAbevacizumab

    ALK positive with TP53 mutation was confirmed by tissue samples or blood in each center

    ALK fusionNon-Small Cell Lung Cancer

  12. X-396(Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases

    Active, not recruiting Phase 2 Fudan University Started 2019Primary completion 2025-06 NCT03753685

    ensartinib FDA

    …tologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.

    ALK fusionNonsmall Cell Lung Cancer, Brain Metastases

  13. Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2018Primary completion 2025-09 NCT03213652

    ensartinib FDA

    … or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

    ALK fusionROS1 fusionAdvanced Malignant Solid Neoplasm, Malignant Solid Neoplasm, Recurrent Ependymoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

  14. 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 Phase 1 M.D. Anderson Cancer Center Started 2021Primary completion 2027-09 NCT04837716

    bevacizumabcarboplatinensartinib FDApemetrexed

    …arboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer

    ALK fusionMetastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8