Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04621188

Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS)

Non Small Cell Lung Cancer Metastatic Clinical Trial

Official title:
A Phase II Single-group Assignment, Multicenter Study of Efficacy and Safety of Lorlatinib Monotherapy After Failure of First-line Tyrosine Kinase Inhibitor in Patients With Advanced ROS1-positive Non-small Cell Lung Cancer (ALBATROS)

Clinical Trial Summary

ROS1 rearrangements are present in 1-2% of NSCLC cases and define a distinct molecular subgroup. Like ALK (anaplastic lymphoma kinase) rearrangements in NSCLC, ROS1 fusions confer sensitivity to the inhibitor crizotinib. Crizotinib, which is a tyrosine kinase inhibitor (TKI), has been shown to be effective in tumors in several retrospective studies. Recently the FDA approved entrectinib for the treatment of patients with ROS1-positive metastatic NSCLC. This indication is based on the results of pooled data from several trials. Together, these studies demonstrate the efficacy for entrectinib across a variety of solid tumor types including NSCLC with ROS1 fusion. However, despite the efficacy of crizotinib or entrectinib in ROS1-positive NSCLC, patients will develop resistance to these tyrosine kinase inhibitors. Lorlatinib is a new and potent ROS1 / ALK inhibitor optimized to penetrate the blood-brain barrier. A recent study has investigated the activity of lorlatinib against the crizotinib-resistant ROS1G2032R mutation. In this situation, lorlatinib effectively inhibited the catalytic activity of recombinant ROS1G2032R resulting in an antiproliferative response. Because of its potency as an ROS1 inhibitor and its ability to suppress the resistant ROS1 mutations, lorlatinib could be a treatment of choice in ROS1-positive NSCLC.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04621188
Study type Interventional
Source Intergroupe Francophone de Cancerologie Thoracique
Contact
Status Recruiting
Phase Phase 2
Start date March 19, 2021
Completion date January 2026
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03168464 - Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632) Phase 1/Phase 2
Recruiting NCT05117242 - Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer Phase 2
Completed NCT04470440 - Thyroid Dysfunction and Nivolumab Reponse in NSCLC
Completed NCT03304093 - Immunotherapy by Nivolumab for HIV+ Patients Phase 2
Terminated NCT04069936 - Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC Phase 2
Active, not recruiting NCT03307785 - Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 Phase 1
Recruiting NCT06100796 - Effect of DM on Outcomes and Response Rate in Patients With Advanced NSCLC on ICI
Recruiting NCT03533127 - A Study of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer Phase 3
Completed NCT04187768 - Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer
Active, not recruiting NCT04951583 - Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma Phase 2
Active, not recruiting NCT03133546 - Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M (BOOSTER) Phase 2
Completed NCT03845270 - Her2-positive Lung Cancer Treated With Dedicated Drug Phase 2
Recruiting NCT05274451 - A Study to Investigate LYL797 in Adults With Solid Tumors Phase 1
Recruiting NCT03774732 - PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer Phase 3
Recruiting NCT06378892 - A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib Phase 2
Active, not recruiting NCT03235765 - Cancer Panel From Blood of Lung Cancer Patients
Not yet recruiting NCT03732482 - Temozolomide Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost for Non Small Cell Lung Cancer Brain Metastases Phase 2/Phase 3
Active, not recruiting NCT02978404 - Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases Phase 2
Recruiting NCT05853887 - Liquid Biopsy Based NGS in Newly Diagnosed NSCLC N/A
Recruiting NCT05429320 - A Study of Local Ablative Therapy (LAT) in People With Non-Small Cell Lung Cancer (NSCLC) Phase 2