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Lung Adenocarcinoma

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Crizotinib

Tyrosine Kinase Inhibitors

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Tyrosine

Patients are treated in this single-arm trial with oral crizotinib 250 mg b.i.d.. Treatment dose will be adjusted according to the protocol if indicated. Treatment will be conducted until disease progression or beyond disease progression according to the protocol if clinically indicated.

250mg crizotinib bid until end of treatment

Juergen Wolf, Prof. Dr. med.

EUCROSS is a phase II trial to evaluate the efficacy and safety of crizotinib in patients with adenocarcinoma of the lung harbouring ROS1 translocations. Patients will be treated with 250mg crizotinib bid until progression or intolerable toxicity.

EUCROSS is a phase II trial to evaluate the efficacy and safety of crizotinib in patients with adenocarcinoma of the lung harbouring ROS1 translocations. In individual treatment attempts and an ongoing phase I trial crizotinib has shown remarkable effects on this selected subgroup of lung cancer patients. Crizotinib is a tyrosine kinase inhibitor, blocking the catalytic activity of rearranged ALK and ROS1 as well as MET. The patients eligible for the trial will be treated with 250mg crizotinib twice-daily. Tumor response to treatment will be assessed every 6 weeks by CT or MRI scans. In case of progression treatment beyond may be conducted if clinically indicated. To identify mechanisms of resistance to crizotinib treatment, an optional re-biopsy may be performed in these cases and fresh frozen tumor material will analyzed at the University of Cologne.

EUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer

EUCROSS: A Phase II Trial to Evaluate Efficacy and Safety of Crizotinib Treatment in Advanced Adenocarcinoma of the Lung Harbouring ROS1 Translocations

CAGE technology (Cap Analysis of Gene Expression) is an RNA based sequencing technology to identify the exact break-apart point as well as the fusion genes.

Mechanisms of resistance to crizotinib will be analysed by molecular pathologic analyses, e.g. NGS and FISH.

CT/MRI scans will be performed to evaluate the efficacy of crizotinib treatment in advanced adenocarcinoma of the lung harbouring ROS1 fusion genes (primary outcome measure: objective response rate (ORR) according to RECIST v.1.1)

CT/MRI scans will be performed to assess the PFS during treatment period.

OS will be assessed by telephone calls every 3 months after the safety follow-up visit.

CT/MRI scans will be performed to asses the DR.

CT/MRI scans will be performed to assess the Time to Tumor Response.

CT/MRI scans will be performed at weeks 6, 12, 24 to assess the DCR.

Safety and tolerability will be assessed on every study visit and for 28 days after end of treatment.

Patient reported outcomes (PRO) of health-related quality of life (HRQoL), disease/treatment related symptoms of lung cancer and general health status

CT/MRI scans will be performed to evaluate the efficacy of crizotinib treatment in advanced adenocarcinoma of the lung harbouring ROS1 fusion genes as confirmed by CAGE sequencing

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
EUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer	NCT02183870	Lung Cancer Adenocarcinoma NSCLC	Crizotinib	18 Years -	University of Cologne
EUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer	NCT02183870	Lung Cancer Adenocarcinoma NSCLC	Crizotinib	18 Years -	University of Cologne

Spots Global Cancer Trial Database for ros1 translocation