Multidisciplinary Treatment of Stage III ALK+ NSCLC With Neoadjuvant Alectinib and Chemotherapy

Starting soon · Phase 2

Conditions studied: Nonsmall Cell Lung Cancer Stage III

In brief

This is a multicenter, phase 2 non-randomized study to investigate the clinical feasibility and therapeutic efficacy of employing a MDT-based strategy in unresectable stage III ALK positive NSCLC following neoadjuvant alectinib in combination with platinum-based chemotherapy. Participants in this study must not have received any previous systemic anticancer therapy before enrollment. The study will consist of a 42-day screening period, a neoadjuvant treatment period, a local radical treatment period, a post-local treatment period, a safety follow-up visit occurring 28 days after the final dose of alectinib, and a survival follow-up period. In the neoadjuvant treatment period, participants will be provided with alectinib (600mg PO BID for 3 cycles) plus platinum-based chemotherapy for a maximum of 3 cycles (each cycle is 21 days). Following the completion of neoadjuvant therapy, all participants who are reassessed by MDT to be resectable after neoadjuvant treatment and have adequate lung functions would be provided with definite surgery. Otherwise, patients would be provided with radical radiotherapy through MDT discussion. For the surgery cohort, participants meet both the R0 resection, the pathological assessment criteria of pCR and have two consecutive landmark ctDNA tests that are negative will receive surveillance after surgery. Participants who do not meet all the above conditions will receive alectinib after surgery, adjuvant treatment should be initiated ideally 4-12 weeks after surgery, or according to local standard of care, treatment will continue until completion of treatment period (24 months), disease recurrence, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first. For the radical radiotherapy cohort, participants will receive alectinib after radiotherapy, adjuvant treatment should be initiated ideally 4-12 weeks after surgery, or according to local standard of care, the treatment will continue until completion of treatment period (24 months), disease progression, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.

Key facts

Study ID

NCT07573696

Run by

Wen-zhao ZHONG

People needed

50

Starts

2026-06-15

Expected to finish

2030-08-07

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Signed Informed Consent Form
• Age ≥ 18 years at time of signing Informed Consent Form
• Ability to comply with the study protocol
• Eligible to receive a platinum-based chemotherapy according to local labels or guidelines
• Cytologically and/or histologically documented locally advanced, unresectable Stage III NSCLC
• Staging should be based on Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system.
• Participants with T4 primary NSCLC with a separate nodule in a different ipsilateral lobe are not eligible.
• Documented ALK fusion positivity by an eligible result from:
• ○ Previously obtained local test results as ordered by a healthcare provider from a high-quality and appropriately validated ALK fusion test on tumor tissue performed in a Clinical Laboratory Improvement Amendments Certified or equivalent laboratory. Acceptable local test methods include the following
• Next-generation sequencing; immunohistochemistry; fluorescence in situ hybridization; reverse transcription-polymerase chain reaction; NanoString.
• Only National Medical Products Administration (NMPA)-approved tests for ALK fusions are acceptable.
• Identification of a specific gene fusion partner is required (exceptions: ALK immunohistochemistry and certain PCR tests for which the gene fusion partner is not pre-specified as part of the test design). The use of positional 5/3 imbalance probe gene expression is not acceptable.
• Eastern Cooperative Oncology Group Performance Status of 0, or 1
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study drug (i.e., Day 1 of Cycle 1):
• ANC ≥1.5 * 109/L (≥1500/L), without granulocyte colony-stimulating factor support
• Platelet count ≥100* 109/L ( 100,000/L), without the need for transfusion
• Hemoglobin ≥ 90 g/L (≥9.0 g/dL)
• Participants may be transfused or receive erythropoietic treatment as per local SOC to meet this criterion.
• AST, ALT, and ALP ≤ 2.5 *upper limit of normal (ULN)
• Bilirubin≤1.5*ULN with the following exception: Participants with known Gilbert disease: bilirubin level ≤ 3* ULN
• Creatinine clearance (CrCl) ≥ 60 mL/min, calculated using the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of CrCl
• Albumin ≥ 25 g/L (≥ 2.5 g/dL)
• For participants not receiving therapeutic anticoagulation: INR and aPTT≤1.5 * ULN

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Any exclusion criteria based on local labels or guidelines for chemotherapy
• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 90 days after the final dose of alectinib or or according to local labels or guidelines for chemotherapy longer), whichever is longer.
• ○ Women of childbearing potential must have a negative serum pregnancy test result prior to enrollment and within 7 days prior to the first dose of alectinib.
• Any history of previous NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)
• Any evidence of Stage IV disease, including, but not limited to, the following:
• Pleural effusion
• Pericardial effusion
• Brain metastases
• History of intracranial hemorrhage or spinal cord hemorrhage
• Bone metastases
• Distant metastases
• If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (T4 disease):
• ○ When pleural fluid is visible on both the CT scan and chest X-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
• Participants with exudative pleural effusions are excluded regardless of cytology.
• Participants with effusions that are minimal (i.e., not visible on chest X-ray) that are too small to safely tap are eligible.
• NSCLC known to have one or more of the following ALK point mutations: I1171X (where X is any other amino acid), V1180L, G1202R
• NSCLC known to have a known or likely oncogenic-driver mutation in the EGFR gene
• Liver disease, characterized by any of the following:
• ○ Impaired excretory function (e.g., hyperbilirubinemia), synthetic function, or other conditions of decompensated liver disease, such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices or Active viral or active autoimmune, alcoholic, or other types of acute hepatitis
• Positive hepatitis B surface antigen (HBsAg) test at screening
• ○ Participants with a previous hepatitis B virus (HBV) infection or resolved HBV infection (hepatitis B core antibody [HBcAb] positive, but negative HBsAg are eligible only if the HBV DNA test is negative.
• Participants known to be positive for hepatitis C virus (HCV) antibody (Ab) are excluded with the following exception:
• ○ Participants who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible.
• HIV infection, participants are excluded if they meet any of the following:

Full record on ClinicalTrials.gov

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