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

NCT07354061 | Recruiting Phase 1

• 1 other identifier: IIT202509-20-KYB-17-XWK
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Ensartinib combined with chemotherapy works as a neoadjuvant treatment for patients with stage II-IIIB (N2) ALK-positive non-small cell lung cancer (NSCLC). It will also learn about the safety of this combination therapy. The main questions it aims to answer are:

• Does Ensartinib combined with chemotherapy lead to a pathological complete response (pCR) in surgically removed tumor tissue after neoadjuvant treatment?
• What medical problems do participants have when taking Ensartinib combined with chemotherapy? This is a single-arm study, meaning all participants will receive the investigational treatment. There is no placebo or active comparator group. The study will be conducted in two stages; the second stage will proceed only if no special, unexpected, or serious adverse events related to Ensartinib occur during the first stage involving 5 participants. Participants will:
• Receive neoadjuvant treatment with Ensartinib (taken orally once daily) plus Pemetrexed and Carboplatin (administered intravenously every 3 weeks) for 9 weeks (3 cycles).
• Undergo surgical resection within 4 weeks after completing neoadjuvant therapy.
• Attend regular clinic visits for check-ups, blood tests, and imaging scans (CT, MRI) according to a detailed schedule during the neoadjuvant, surgical, and long-term follow-up periods (up to 10 years).
• Be monitored for adverse events and survival outcomes.

Conditions

NSCLC (Non-small Cell Lung Cancer)

Keywords

Ensartinib; neoadjuvant; ALK - positive; Resectable

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR)

  From enrollment to the end of treatment at 9 weeks

Secondary Outcomes (9)

• Major pathological response rate (MPR)

  From enrollment to the end of treatment at 9 weeks

• Objective Response Rate (ORR)

  From enrollment to the end of treatment at 3 years

• R0 Resection Rate

  Evaluated immediately after surgical intervention

• 3-year EFS Rate

  Measured over a period of 3 years from study entry or treatment initiation

• Event-Free Survival (EFS)

  From enrollment to the end of treatment at 5 years

Study Arms (1)

Ensartinib + Chemotherapy

EXPERIMENTAL

Drug: Ensartinib + Chemotherapy

Interventions

Ensartinib + Chemotherapy DRUG

For patients with operable stage II - IIIB (N2) ALK - fusion - positive lung adenocarcinoma, after signing the informed consent form and being screened to meet the inclusion and exclusion criteria, they will receive treatment with ensartinib combined with pemetrexed and carboplatin for a duration of 9 weeks. Subsequently, after a comprehensive assessment, they will undergo surgical treatment. After the surgery, the pathological complete response rate (pCR), major pathological response rate (MPR), objective response rate (ORR), R0 resection rate, safety, etc. of the patients will be evaluated. Then, the researchers will decide whether the patients will receive post - operative adjuvant treatment according to the situation, until reaching the duration of post - operative adjuvant treatment, disease recurrence, death, loss to follow - up, or study termination, whichever occurs first.This study is divided into two stages. In Stage 1, 5 subjects will be enrolled as required to receive neo

Ensartinib + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent prior to any study-specific procedures.
• Aged between 18 and 75 years old (inclusive).
• Histologically or cytologically confirmed lung adenocarcinoma via biopsy performed within 60 days prior to study enrollment.
• Surgically resectable Stage II-IIIB (N2) lung adenocarcinoma (AJCC 8th Edition TNM Staging).
• Confirmed ALK fusion mutation by detection methods recommended by NCCN guidelines.
• Presence of at least one accurately measurable lesion, with the longest diameter ≥10 mm on baseline computed tomography (CT) scan (or lymph nodes with a short axis ≥15 mm) and suitable for accurate repeated measurements.
• ECOG performance status of 0-1.
• Adequate hematological, biochemical, and organ function:
• Hemoglobin ≥90 g/L (can be maintained or exceeded via transfusion);
• Absolute neutrophil count ≥1.5×10⁹/L;
• Platelet count ≥90×10⁹/L;
• Total bilirubin ≤2× upper limit of normal (ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN;
• Creatinine ≤1.5× ULN; and creatinine clearance ≥60 mL/min.
• Adequate cardiopulmonary function suitable for surgical treatment (assessed by ECG, echocardiography, pulmonary function tests, or blood gas analysis).

You may not qualify if:

• Presence of squamous cell carcinoma, large cell neuroendocrine carcinoma, or small cell carcinoma components.
• Prior exposure to other anti-tumor therapies before enrollment.
• Patient is pregnant or breastfeeding.
• Current use of (or inability to discontinue use at least 3 weeks prior to receiving the first dose of study treatment) drugs or herbal supplements known to be strong inducers of CYP3A4. All patients must try to avoid concomitant use or ingestion of any drugs, herbal supplements, and/or foods known to have CYP3A4 induction effects.
• Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, which in the investigator's opinion would compromise the patient's participation in the study or protocol compliance, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
• Prior history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any current evidence of active ILD.
• History of hypersensitivity to active or inactive excipients of Ensartinib or drugs with similar chemical structures or classes to Ensartinib, as well as uncontrollable nausea and vomiting, chronic gastrointestinal diseases, inability to swallow formulated medication, or prior extensive bowel resection that would preclude adequate absorption of Ensartinib.
• Intolerance to chemotherapy or refusal of chemotherapy.
• Any of the following cardiac criteria:
• Mean resting corrected QT interval (QTc) \> 470 msec obtained from three ECGs using the screening ECG machine's QTc value.
• Any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG, such as left bundle branch block, third-degree heart block, or second-degree heart block.
• Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death under 40 years of age in first-degree relatives, or any concomitant medication known to prolong the QT interval.
• History of definite neurological or psychiatric disorders, including epilepsy or dementia.
• Any other conditions deemed by the investigator as unsuitable for enrollment.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi’an, Shanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ensartinib; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yan xiaolong Doctor

CONTACT

0086-17791384643; yanxiaolong@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 21, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): March 25, 2028
• Study Completion (Estimated): December 30, 2030
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)