Clinical Trials Logo
  1. Home
  2. Carcinoma, Non-Small-Cell Lung
  3. NCT04887519

A Study of Brigatinib to Treat Adults With Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non Small Cell Lung Cancer (NSCLC)

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:
Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Brigatinib (Alunbrig®) in Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non Small Cell Lung Cancer (NSCLC) in Argentina

Clinical Trial Summary

The aims of the study are to assess the safety profile of brigatinib and the clinical response rates in adults with Anaplastic Lymphoma Kinase (ALK)-Positive Metastatic Non Small Cell Lung Cancer (NSCLC). Treatment with brigatinib and follow-up will be according to routine clinical practice. Study doctors will review the participants' medical records at the start of the study, then at 12 and 24 weeks after treatment starts.

Clinical Trial Description

This is a prospective, observational post-marketing surveillance study of brigatinib in participants with advanced or metastatic NSCLC. This study will assess the safety, efficacy and effectiveness of brigatinib for its approved indications in a routine clinical practice setting under real world use. The study will enroll approximately 37 participants. The data will be collected both prospectively and/or retrospectively at the specialized centers and outpatient oncology clinics and will be recorded by the investigator in the electronic Case Report Form (eCRF) based on the routine medical care data that is collected in the medical records. All the participants will be assigned to a single observational cohort: • All Participants This multi-center study will be conducted in Argentina. The overall duration of the study will be approximately 52 weeks. Data collection will be based on routine visit after every 12 weeks from the start of treatment up to 24 weeks of follow up or death or cancer progression or treatment discontinuation, whichever occurs first. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04887519
Study type Observational
Source Takeda
Contact
Status Completed
Phase
Start date December 30, 2020
Completion date March 31, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT04879849 - A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers Phase 1
Completed NCT04426825 - A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer Phase 2
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT02810457 - Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer Phase 3
Completed NCT02864394 - Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033) Phase 3
Recruiting NCT04592523 - A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
Recruiting NCT04838548 - A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer Phase 2
Recruiting NCT04077463 - A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer Phase 1
Recruiting NCT05167604 - Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
Recruiting NCT04603807 - A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases Phase 3
Completed NCT04948411 - Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
Active, not recruiting NCT04487080 - A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Phase 3
Not yet recruiting NCT04255836 - Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC) Phase 2
Completed NCT01953913 - Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation Phase 3
Recruiting NCT05715229 - Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy Phase 2
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Suspended NCT05421936 - Osimertinib for NSCLC With Uncommon EGFR Mutations
Completed NCT02847377 - A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC N/A
Completed NCT04427072 - Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation Phase 3
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A