---
title: Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
nct_id: NCT05241028
overall_status: RECRUITING
phase: PHASE2
sponsor: Hebei Medical University Fourth Hospital
study_type: INTERVENTIONAL
primary_condition: Non-small Cell Lung Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05241028.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05241028"
ct_last_update_post_date: 2023-10-10
last_seen_at: "2026-05-12T06:31:24.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer

**Official Title:** 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

**NCT ID:** [NCT05241028](https://clinicaltrials.gov/study/NCT05241028)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** Hebei Medical University Fourth Hospital
- **Conditions:** Non-small Cell Lung Cancer
- **Start Date:** 2022-05-01
- **Completion Date:** 2029-02
- **CT.gov Last Update:** 2023-10-10

## Brief 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

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Having targeted medication therapy (including tyrosine kinase inhibitor or monoclonal antibody) and experimental therapy for NSCLC in the past.
* Having local radiotherapy of NSCLC.
* Known allergy to Ensatinib or any of the ingredients in this product.
* Previously suffering from interstitial lung disease, drug-induced interstitial disease, radiation pneumonia that requires hormone therapy, or any clinically evidenced active interstitial lung disease; CT scan at baseline revealed the presence of idiopathic pulmonary fibrosis.
* Any unstable systemic disease, including: active infection, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that started within the last 3 months, congestive heart failure (≥ New York Heart Association \[NYHA\] II Grade), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medical treatment; liver, kidney or metabolic diseases.
* Women who are pregnant or breastfeeding.
* Having history of neurological or psychiatric disorders, including epilepsy or dementia.
* Other conditions investigators evaluate that patient is not eligible to this study.
```

## Arms

- **Ensartinib** (EXPERIMENTAL) — Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity

## Interventions

- **Ensartinib** (DRUG) — Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity

## Primary Outcomes

- **3-year disease free survival rate (DFSR)** _(time frame: 3 years)_ — Defined as the percentage of patients alive and disease free at 3 years

## Secondary Outcomes

- **5-year overall survival rate** _(time frame: 5 years)_
- **disease free survival (DFS)** _(time frame: Up to 5 years)_
- **overall survival (OS)** _(time frame: Up to 5 years)_
- **Adverse Events** _(time frame: Up to 3 years)_

## Locations (1)

- Jun Feng Liu, Shijiazhuang, Hebei, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.jun feng liu|shijiazhuang|hebei|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05241028*  
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