Adjuvant Therapy of Ensatinib in Patients With Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer: a Prospective, Multi-center, Single-arm Exploratory Study

Who is this study for? Patients with stage IB-IIIA ALK-positive non-small cell lung cancer
What treatments are being studied? Ensartinib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC) with positive ALK-fusion. Enrolled patients will take Ensatinib for 3 years or until recurrence of the disease or intolerable toxicity, following complete tumour resection with or without adjuvant standard chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

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

• Males or females aged ≥18 years, ≤75 years.

• ECOG performance status 0-2.

• Completely recovered from surgery or standard postoperative chemotherapy before receiving adjuvant ensatinib treatment. (When starting the study treatment, the patient must have recovered from all toxicities greater than CTCAE Grade 1 caused by the previous treatment, except for hair loss and Grade 2 neuropathy related to previous platinum-based treatments).

• Clinical examinations before treatment report no signs of disease recurrance.

• With enough tumor histology specimens (non-cytology) for molecular marker analysis.

• hemoglobin concentration ≥ 100 g/L (permit to maintain hematologic criteria by blood transfusion); absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelet count ≥100×10\^9/L.

• Liver Function: TBil ≤2xULN; ALT and AST ≤2.5xULN;

• Renal Function: Cr ≤1.5xULN, and Ccr ≥60ml/min;

• Signed inform consent form by patient or his/her legal representative.

• Comply with study protocol and procedure, and be able to take oral medication.

• Female patients of childbearing potential must have a negative urine pregnancy test within 7 days before study treatment.

• Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 8 weeks after their last dose of study therapy.

Locations
Other Locations
China
Jun Feng Liu
RECRUITING
Shijiazhuang
Contact Information
Primary
Junfeng Liu, PhD
liujf@hbmu.edu
13931152296
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2029-02
Participants
Target number of participants: 80
Treatments
Experimental: Ensartinib
Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity
Sponsors
Leads: Hebei Medical University Fourth Hospital

This content was sourced from clinicaltrials.gov

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