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Not yet recruitingNCT06736561Updated Dec 16, 2024

A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.

An observational study in ALK Positive, Ensartinib and NSCLC, sponsored by Harbin Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by Harbin Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

Explore the efficacy and safety of Ensartinib in neoadjuvant treatment for ALK-positive non-small cell lung cancer in the real world.This is a real-world study of patients receiving enshatinib-based neoadjuvant therapy with R0 resection, divided into retrospective cohort 1, prospective cohort 2, and prospective cohort 3. The dose, duration, and whether to combine or sequentially treat enshatinib were clinical decisions made by the investigator on a patient-specific basis.

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Conditions studied

  • ALK Positive
  • Ensartinib
  • NSCLC
  • Neoadjuvant Therapy

Keywords

  • ALK Positive
  • Ensartinib
  • NSCLC
  • Neoadjuvant therapy
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In context

Carcinoma, Non-Small-Cell Lung

6,491 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,633 are open to participants now.

This study's planned enrollment of 100 is below the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Harbin Medical University is the lead sponsor of 87 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ALK+

Inclusion criteria

  1. Cohort 1: Female or male aged >=18 years;
  2. Cohort 1: Received neoadjuvant treatment with Ensartinib before the project started;
  3. Cohort 1: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;
  4. Cohort 1: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy.
  5. Cohort 2: Female or male aged >=18 years;
  6. Cohort 2: Intended to receive Ensartinib monotherapy as neoadjuvant treatment for 6-12 weeks;
  7. Cohort 2: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;
  8. Cohort 2: Confirmed ALK positive by immunohistochemistry (IFL), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;
  9. Cohort 2: Signed informed consent form;
  10. Cohort 3: Female or male aged >=18 years;
  11. Cohort 3: Intended to receive neoadjuvant treatment including Ensartinib, but not meeting the inclusion criteria for Cohort 2;
  12. Cohort 3: Diagnosed with clinical stage II-III resectable or potentially resectable ALK-positive NSCLC before neoadjuvant treatment;
  13. Cohort 3: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;
  14. Cohort 3: Signed informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Cohort 1: Patients who have received treatment with Ensartinib after the project has started;
  2. Cohort 1: Patients who have received Ensartinib treatment but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
  3. Cohort 1: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
  4. Cohort 1: Patients who are participating in other clinical studies outside of this research;
  5. Cohort 1: Other circumstances deemed unsuitable for enrollment by the researchers.
  6. Cohort 2: Patients who have received Ensartinib treatment before the study started;
  7. Cohort 2: Patients who have received other systemic treatments besides Ensartinib;
  8. Cohort 2: Neoadjuvant treatment cycles less than 6 weeks or more than 12 weeks;
  9. Cohort 2: Patients who have received Ensartinib monotherapy but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
  10. Cohort 2: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
  11. Cohort 2: Patients who are participating in other clinical studies outside of this research;
  12. Cohort 2: Other circumstances deemed unsuitable for enrollment by the researchers.
  13. Cohort 3: Patients who have received neoadjuvant treatment containing Ensartinib but meet the enrollment criteria for Cohort 2;
  14. Cohort 3: Patients who have received treatment containing Ensartinib but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
  15. Cohort 3: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
  16. Cohort 3: Patients who are participating in other clinical studies outside of this research;
  17. Cohort 3: Other circumstances deemed unsuitable for enrollment by the researchers.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
100 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Cohort 1

    Data on the efficacy and safety of patients who had previously used enshatinib in the neoadjuvant phase were retrospectively collected

  • Cohort 2

    Akl-positive patients received enshatinib monotherapy neoadjuvant therapy for 6-12 weeks

  • Cohort 3

    Alk-positive patients received neoadjuvant therapy that included enshatinib and did not meet cohort 2 inclusion criteria

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What researchers measure

Primary outcomes

  1. MPR

    Main pathological remission rate

    Time frame: 6month

Secondary outcomes

  1. pCR

    Pathological complete response rate

    Time frame: 6month

  2. 2-year disease-free survival rate

    2-year disease-free survival rate

    Time frame: 2year

  3. ORR

    Objective response rate

    Time frame: 1year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06736561
Lead sponsor
Harbin Medical University
Responsible party
Jianqun Ma (archiater, Harbin Medical University) — Principal investigator
First posted
Dec 16, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Dec 16, 2024

Study contacts

Ma
Contact
jianqunma@aliyun.com
86+ 18646101888

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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