RecruitingPhase 2NCT05241028

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

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


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

80 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether ensartinib — a targeted pill that blocks a cancer-driving protein called ALK — reduces the chance of lung cancer coming back after surgery in patients with early-stage non-small cell lung cancer (NSCLC) that has the ALK genetic abnormality. **You may be eligible if...** - You are 18 to 75 years old with completely removed (resected) stage IB to IIIA NSCLC - Your tumor is confirmed to have an ALK gene fusion (by genetic testing) - You have recovered from surgery and/or post-surgery chemotherapy - You have no signs of cancer recurrence **You may NOT be eligible if...** - You have received any targeted therapy or immunotherapy for lung cancer before - You have had lung radiation therapy previously - You have a known allergy to ensartinib - You have active interstitial lung disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGEnsartinib

Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity


Locations(1)

Jun Feng Liu

Shijiazhuang, Hebei, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05241028


Related Trials