Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

This is a single-arm study of patients who plan on starting brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days to brigatinib 180 mg QD. Study procedures include PFTs, 6minute walk test, Modified Borg dyspnea scale (mBDS), and phlebotomy before participants commence brigatinib and on days 2 and 8 of brigatinib treatment. Participants that develop a peak reduction in DLCO of 20% or more from baseline whose DLCO does not return to their baseline level on day 8 may, at the discretion of the investigator, undergo repeated testing on a subsequent time point (e.g., day 15) for serial observation to ensure resolution of EOPE if that is the suspected cause of DLCO reduction.

Camidge Ross, MD

To estimate the incidence of Early Onset Pulmonary Events (EOPEs), defined as the proportion of participants with a peak reduction in DLCO of 20% or greater after commencing brigatinib at 90mg QD.

This is a single-arm study of patients who plan on starting brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days to brigatinib 180 mg QD. Participants who enroll on this study protocol will either be taking brigatinib in the context of an ongoing clinical trial, or as part of standard of care treatment as licensed by FDA.

Pulmonary Physiology and Systemic Inflammatory in EO Pulmonary Events With Brigatinib Use in NSCLC and Other Diseases

Pulmonary Physiology and Systemic Inflammatory Signature Investigations in Early Onset Pulmonary Events Associated With Brigatinib Use in Non-Small Cell Lung Cancer and Other Diseases

EOPEs is defined as the proportion of participants with a peak reduction in Diffusion capacity in the Lung of Carbon monoxide (DLCO) of 20% or greater after commencing brigatinib at 90mg once daily QD.

Takeda Pharmaceuticals International, Inc.

Academic Thoracic Oncology Medical Investigators Consortium

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pulmonary Physiology and Systemic Inflammatory in EO Pulmonary Events With Brigatinib Use in NSCLC and Other Diseases	NCT03389399	Non-Small Cell ...		18 Years - 100 Years	University of Colorado, Denver
Pulmonary Physiology and Systemic Inflammatory in EO Pulmonary Events With Brigatinib Use in NSCLC and Other Diseases	NCT03389399	Non-Small Cell ...		18 Years - 100 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for early onset pulmonary events