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

ConditionNeoadjuvant Non-Small Cell Lung Cancer

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorGuangdong Association of Clinical Trials

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

lorlatinib
Drug
Eligible patients will be registered to receive oral lorlatinib 100mg qd for 36 months during the treatment phase.
concurrent/sequential platinum-based chemoradiotherapy
Other intervention
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.

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: lorlatinib treatmentActive comparator 1 intervention

Group B: concurrent/sequential platinum-based chemoradiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Association of Clinical Trials

Lead sponsor

Source ClinicalTrials.gov

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