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NCT06858410

PHASE3

Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma

Sponsor: Guangdong Association of Clinical Trials

View on ClinicalTrials.gov

Summary

The project is a Phase III, randomized, open-label, multicenter study in which approximately 36 patients with unresectable Stage III ALK positive Lung Adenocarcinoma will be randomized 1:1 to receive lorlatinib or concurrent/sequential platinum-based chemoradiotherapy

Official title: A Randomized, Open-label, Multicenter, Phase III Study of Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy As Definitive Treatment in Patients with Locally Advanced, Unresectable Stage III ALK Positive Lung Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-03

Completion Date

2030-08

Last Updated

2025-03-05

Healthy Volunteers

Conditions

Neoadjuvant Non-Small Cell Lung Cancer

Interventions

DRUG

lorlatinib

Eligible patients will be registered to receive oral lorlatinib 100mg qd for 36 months during the treatment phase.

OTHER

concurrent/sequential platinum-based chemoradiotherapy

The choice of chemotherapy and will be determined by the investigator prior to treatment allocation and the radiotherapy also according to the clinical therapy regimen decided by the investigator.

Inclusion Criteria: * Study Population: Patients with histologically or cytologically confirmed diagnosis of ALK-positive, lung adenocarcinoma who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer \[IASLC\]). * Tumor Requirements: At least 1 measurable target lesion per RECIST v. 1.1 * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1. Life expectancy at least 12weeks at Day1. * Age ≥18 years. * Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: * Previously received any ALK-TKIs or any thoracic radiotherapy * Active infection, including Bacteria, fungi or viruses * Any evidence of severe or uncontrolled systemic diseases, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol * Inadequate bone marrow reserve or organ function. 1. Absolute neutrophil count \<1.5\*109/L 2. Platelet count \<90\*109/L 3. Hemoglobin \<90 g/L (\<9 g/dL) d Alanine aminotransferase \> 3 times the upper limit of normal (ULN) e. Aspartate aminotransferase \> 3 times the upper limit of normal (ULN) f. Total bilirubin \> 1.5\*ULN g. Creatinine \>1.5\*ULN or creatinine clearance \<45 mL/min (calculated by Cockcroft-Gault formula) * History of interstitial lung disease (ILD) or active ILD or pneumonia * Pregnant female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 97 days, if male or 35 days if female, after the last dose of investigational product under lorlatinib. * Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation. * Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements