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.
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).
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.
Single group
Ensartinib + Chemotherapy
DrugFor 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
Pathological complete response rate (pCR)
Major pathological response rate (MPR)
Objective Response Rate (ORR)
R0 Resection Rate
3-year EFS Rate
Click on the lead sponsor to view all of their trials.
