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Tyrosine Kinase Inhibitors

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Tyrosine

1. st line: Any approved 2nd-generation TKI according to investigator's choice
2. nd line: Any available ALK TKI according to investigator's choice (patients from the standard Arm A can be offered brigatinib in the 2nd line)

1. st line: 90 mg brigatinib once daily p.o. for the first 7 days (lead-in) followed by 180 mg brigatinib once daily p.o. afterwards, starting with day 8
2. nd line: Any available ALK TKI according to investigator's choice

Brigatinib

Tyrosine kinase inhibitor

Salah-Eddin Al-Batran, Prof.

This is a prospective, randomized, open-label, multicenter phase II study investigating the advancing Brigatinib properties in anaplastic lymphoma kinase positive non-small cell lung cancer (ALK+ NSCLC) patients by deep phenotyping

The aim of this study is to compare efficacy of brigatinib and other 2nd-generation ALK tyrosin kinase inhibitor (TKI) in 1st and 2nd line treatment and to explore resistance patterns according to treatment and molecular properties of the tumors

Advancing Brigatinib Properties in ALK+ NSCLC Patients by Deep Phenotyping

Advancing Brigatinib Properties in Anaplastic Lymphoma Kinase Positive Non-small Cell Lung Cancer (ALK+ NSCLC) Patients

Typing of ALK fusion variants in tumor samples

Typing of ALK fusion variants in blood samples

Assessment of TP53 mutation status in tumor samples

Assessment of TP53 mutation status in blood samples

Detection of "acquired resistance" mutations via standardized next-generation sequencing (NGS)-based multiplex analysis in tumor samples

Detection of "acquired resistance" mutations via standardized next-generation sequencing (NGS)-based multiplex analysis in blood samples

Typing of ALK fusion variants in cerebrospinal fluid in "brain-only" progression.

Assessment of TP53 mutation status in cerebrospinal fluid in "brain-only" progression.

Detection of "acquired resistance" mutations via standardized circulating tumor DNA (ctDNA) next-generation sequencing (NGS)-based multiplex analysis in cerebrospinal fluid

Time from the first dosing date of any study medication to the date of the first objectively documented tumor progression or death due to any cause

Time from the first dosing date of any 2nd-line TKI to the date of the objectively documented tumor progression or death due to any cause

Time from begin of 1st-line treatment until begin of 2nd-line treatment

Time from begin of 2nd line until begin of 3rd-line treatment

Time from begin of 1st-line treatment until begin of 3rd-line treatment

Time from treatment start in the 1st line to the date of death (due to any cause)

Percentage of participants with a best overall intracranial response (BOR) of intracranial complete response (CR) or intracranial partial response (PR). Best overall intracranial response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented intracranial tumor progression per RECIST criteria or the date of subsequent therapy or death, whichever occurs first.

Time from first documentation of intracranial CR or PR according to RECIST v1.1 (whichever is first recorded) until the first date that the intracranial progressive disease (PD) is objectively documented or until death (whichever occurs first

Time from start of 1st-line treatment until the occurrence of a new central nervous system (CNS) lesion or progression of pre-existing CNS lesions

Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)graded according to NCI CTCAE v5.0

Patient reported outcome assessed by the validated SF-12-questionnaire

Patient reported outcome assessed by the validated EORTC-QLQ-BN20-questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Advancing Brigatinib Properties in ALK+ NSCLC Patients by Deep Phenotyping	NCT04318938	NSCLC	Brigatinib Tyrosine kinase...	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Advancing Brigatinib Properties in ALK+ NSCLC Patients by Deep Phenotyping	NCT04318938	NSCLC	Brigatinib Tyrosine kinase...	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Spots Global Cancer Trial Database for resistance patterns