Study of Crizotinib for ROS1 and MET Activated Lung Cancer

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Sep 8, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a drug called crizotinib for patients with advanced non-small cell lung cancer (NSCLC) that has specific gene changes known as ROS1 or MET. These changes can make the cancer harder to treat, and researchers want to see how effective crizotinib is for these patients. The trial is currently recruiting participants aged 18 and older who have been diagnosed with stage IV NSCLC and have a confirmed ROS1 rearrangement or MET mutation/amplification. To join, patients should have measurable cancer, good overall health, and the ability to understand the study requirements.

Participants in this trial will receive crizotinib, also known as XALKORI, which is already approved for certain types of lung cancer. They will be monitored closely by doctors for any side effects and to evaluate how well the treatment is working. It's important to note that patients with untreated brain metastases or those who have recently undergone certain cancer treatments may not be eligible. Additionally, women who are pregnant or planning to become pregnant during the study cannot participate. This trial offers a chance for patients with specific genetic changes in their lung cancer to receive a targeted treatment that might help improve their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically or cytologically confirmed diagnosis of stage IV or incurable non-squamous non-small cell lung cancer with a documented ROS1 rearrangement (cohort 1) or MET-activating mutation (exon 14) (cohort 2) or MET-amplification (cohort 3) tested in either plasma or tissue, as applicable
• • 18 years of age or older.
• • Measurable disease as per RECIST v1.1.
• • Adequate hematologic and organ function within 7 days of the proposed start date of treatment and adequate cardiac function within 28 days of the proposed start date of treatment
• • Life expectancy \>12 weeks.
• • Have the ability to understand and the willingness to sign a written informed consent document
• • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• • No contraindication to Crizotinib therapy
• • Able to swallow and retain oral medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
• • No pregnant
• • Agree to use methods (as agreed upon by the study doctor and participant) before the study and for at least 120 days after the last dose of study drug to prevent pregnancy
• Exclusion Criteria:
• • Symptomatic untreated brain metastases.
• • Had chemotherapy (including investigational cytotoxic chemotherapy), biologic agents (e.g. targeted therapy or antibodies) within 4 weeks or radiotherapy within 2 weeks prior to the proposed first dose of study treatment.
• • Adverse events attributed to prior anti-cancer therapy \> Grade 1 if clinically relevant.
• • Receiving medications or substances known to be strong inhibitors or inducers of CYP3A4.
• • Any known intolerance to agents structurally similar to crizotinib.
• • Congenital long QT syndrome or persistent corrected QT interval by Fredericia formula (QTcF) ≥ 500 msec.
• • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues