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

NCT06858410 | Not Yet Recruiting Phase 3

• 1 other identifier: CTONG2403
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Neoadjuvant Non-Small Cell Lung Cancer

Keywords

ALK-positive; Stage III unresectable; Lung Adenocarcinoma; NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression Free Survival (PFS) is defined as the time from start of lorlatinib treatment to the date of disease progression as defined by RECIST v1.1 per investigator review or death due to any cause, whichever occurred first

  up to 36 months from date of randomization until the date of first documented progression or date of death from any cause, whichever came first

Study Arms (2)

lorlatinib treatment

ACTIVE COMPARATOR

In lorlatinib group, eligible patients will be registered to receive oral lorlatinib 100mg qd for 36 months during the treatment phase. Lorlatinib will be administered orally QD at approximately the same time of the day on a continuous daily dosing schedule, ie, without a break in dosing in the absence of drug-related toxicity

Drug: lorlatinib

concurrent/sequential platinum-based chemoradiotherapy

ACTIVE COMPARATOR

In concurrent/sequential platinum-based chemoradiotherapy group, 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.

Other: concurrent/sequential platinum-based chemoradiotherapy

Interventions

lorlatinib DRUG

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

lorlatinib treatment

concurrent/sequential platinum-based chemoradiotherapy OTHER

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.

concurrent/sequential platinum-based chemoradiotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Absolute neutrophil count \<1.5\*109/L
• Platelet count \<90\*109/L
• 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

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

lorlatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• E E Ke, M.D.

  Guangdong Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Yi L Wu, M.D.

CONTACT

18928737479; syylwu@live.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pulmonology

Model Details: A randomized, open-label, parallel study Lorlatinib compared with concurrent/ sequential chemoradiotherapy in locally advanced, unresectable Stage III ALK positive Lung Adenocarcinoma

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share