Clinical Trials Logo
  1. Home
  2. Non-Small Cell Lung Cancer
  3. NCT05200481

Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)

Non Small Cell Lung Cancer Clinical Trial

Official title:
A Phase II Randomized, Open-Labelled, Multicenter Study of Safety & Efficacy of Combination Brigatinib and Carboplatin-Pemetrexed Therapy or Brigatinib Monotherapy as First-Line Treatment in Advanced ALK-Positive Non-Small Cell Lung Cancer

Clinical Trial Summary

This is a phase II randomized, open-labelled, non-comparative multicenter study in which ALK+ NSCLC patients who are naïve of treatment for advanced disease will be randomized to receive brigatinib monotherapy (Arm A) or brigatinib and carboplatin-pemetrexed therapy (Arm B). An estimated 110 patients (55 in Arm A, 55 in Arm B) will be enrolled at approximately 30 centers. A safety phase will evaluate the safety of brigatinib with carboplatin and pemetrexed treatment combination (Arm B). The first twenty-six patients enrolled in Arm B will represent the population of the safety phase. Patients will be treated until they experience progressive disease, intolerable toxicity, or another discontinuation criterion is met. Continuation of brigatinib beyond progression is permitted, at the investigator's discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 12 months ≤ 69% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 86% or more of patients in Arm B would achieve progression free survival at 12 months.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05200481
Study type Interventional
Source Intergroupe Francophone de Cancerologie Thoracique
Contact Opérations Cliniques
Phone +33156811045
Email contact@ifct.fr
Status Recruiting
Phase Phase 2
Start date May 18, 2022
Completion date October 2028
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Completed NCT01945021 - Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC Phase 2
Recruiting NCT04487457 - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Terminated NCT04022876 - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Phase 1
Recruiting NCT05532696 - Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients Phase 1/Phase 2
Active, not recruiting NCT04311034 - A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer Phase 1/Phase 2
Recruiting NCT03257722 - Pembrolizumab + Idelalisib for Lung Cancer Study Phase 1/Phase 2
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Completed NCT00349089 - Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy Phase 2
Active, not recruiting NCT05116891 - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04571632 - Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors Phase 2
Not yet recruiting NCT04650490 - SRS Timing With Immune Checkpoint Inhibition in Patients With Untreated Brain Metastases From Non-small Cell Lung Cancer Phase 2
Withdrawn NCT03982134 - PDR001 + Panobinostat for Melanoma and NSCLC Phase 1
Withdrawn NCT03574649 - QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer Phase 2
Withdrawn NCT02844140 - DE-CT in Lung Cancer Proton Therapy N/A
Completed NCT03780010 - Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC Phase 1
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Active, not recruiting NCT02136355 - A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer N/A
Completed NCT01943578 - Value of Physical Capacity Tests in Lung Cancer N/A