Clinical trial · Interventional

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

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

NCT06858410CI-TRIAL-00086777not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Neoadjuvant Non-Small Cell Lung Cancer	Lung Adenocarcinoma	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
concurrent/sequential platinum-based chemoradiotherapy	Other	—	UNRESOLVED
lorlatinib	Drug	Lorlatinib	ALIAS

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
lorlatinib treatment
description
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
interventionNames
1. Drug: lorlatinib
type
ACTIVE_COMPARATOR
label
concurrent/sequential platinum-based chemoradiotherapy
description
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.
interventionNames
1. Other: concurrent/sequential platinum-based chemoradiotherapy

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.