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Clinical trial of multiple therapies for patients with advanced or metastatic non-small cell lung cancer (cpnm) carrying actionable somatic mutations detected in blood.
THE PURPOSE OF THIS STUDY IS TO TEST WHAT EFFECTS, GOOD OR BAD, ALECTINIB HAS ON THE PATIENT AND ALK-POSITIVE NSCLC (DETERMINED BY THE RESULT OF THE BLOOD TEST THAT CONFIRMED THE PATIENT'S ELIGIBILITY FOR THIS TREATMENT). ALECTINIB HAS BEEN APPROVED IN JAPAN FOR THE TREATMENT OF PATIENTS WITH SURGICALLY UNRESECTABLE, RECURRENT OR ADVANCED NSCLC WHO HAVE A MUTATION IN THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE RESPONSIBLE FOR THE HIGHER-THAN-NORMAL ACTIVITY OF ALK. ALECTINIB HAS ALSO BEEN APPROVED IN THE UNITED STATES, CANADA, THE EUROPEAN UNION, HONG KONG, SOUTH KOREA AND OTHER COUNTRIES FOR THE TREATMENT OF PATIENTS WITH ALK-MUTATED METASTATIC NSCLC WHOSE DISEASE HAS WORSENED DURING TREATMENT WITH THE ALK INHIBITOR CRIZOTINIB OR WHO ARE INTOLERANT TO THIS TREATMENT.
- PHASE II/III, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MULTIPLE TARGETED THERAPIES AS TREATMENT FOR PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (CPNM) CARRYING ACTIONABLE SOMATIC MUTATIONS DETECTED IN BLOOD (B-FAST: FIRST BLOOD SCREENING TEST).
- Code EudraCT: 2017-000076-28
- Protocol number: BO29554
- Promoter: F. Hoffmann-La Roche Ltd.
- Molecule/Drug: Alectinib (RO5424802), Atezolizumab
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