A clinical study for patients with newly diagnosed, locally advanced non-small cell lung cancer (NSCLC) with a change in the ALK-gene, to test the effect of brigatinib after standard chemotherapy and radiation therapy is completed.

Korábbi kezelés

• Most important exclusion criteria for enrolment: • Diagnosis of another primary malignancy other than NSCLC. • Prior treatment for NSCLC • Any evidence of stage IV NSCLC • Significant, uncontrolled, or active cardiovascular disease - History of clinically significant atrial arrhythmia (including clinically significant brady-arrhythmia), as determined by the treating physician. - Any history of clinically significant ventricular arrhythmia. - Cerebrovascular accident or transient ischemic attack within 6 months before enrolment. - Myocardial infarction within 6 months before enrolment. - Unstable angina within 6 months before enrolment. - Congestive heart failure within 6 months before enrolment. • Uncontrolled hypertension: Patients with hypertension should be under treatment on study entry to control blood pressure. • History or the presence at baseline of pulmonary interstitial disease, drug-related pneumonitis. • Ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics. • Malabsorption syndrome or other GI illness that could affect oral absorption of brigatinib. • Known or suspected hypersensitivity to brigatinib or its excipients. • Any concurrent medical condition which, in the opinion of the investigator, would compromise patient safety or interfere with the evaluations of brigatinib.

• Most important inclusion criteria for enrolment: • Pathologically documented, treatment naïve unresectable stage III NSCLC • Documented ALK-fusion, tested locally on tumor tissue by a validated method (DNA NGS, RNA NGS, FISH, IHC, or ctDNA) • ECOG Performance Status 0-1 • Age ≥18 years • Patient is a candidate to receive chemo-radiotherapy, as per investigator’s assessment (including adequate haematological, renal and liver function as per local clinical practice). • Negative pregnancy test for women of childbearing potential. • Ability to comply with the trial protocol, in the investigator's judgment. • Written informed consent for trial participation must be signed and dated by the patient and the investigator prior to any trial-related intervention, including the submission of mandatory biomaterial. Most important inclusion criteria for randomisation: Randomisation of eligible patients must occur within 8 weeks after the last radiotherapy fraction. • Completion of thoracic radiotherapy • Non-PD at restaging • Adequate haematological, renal and liver function. • Negative pregnancy test for women of childbearing potential • No radiation pneumonitis of grade ≥2 • All other AEs from previous chemo-radiotherapy resolved to grade <2 (except for alopecia) • ECOG 0-2 • No major surgery, as defined by the investigator, within 4 weeks of the first planned dose of brigatinib. Minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed. • No systemic treatment with strong cytochrome p-450 (cyp)3a inhibitors, strong cyp3a inducers, or moderate cyp3a inducers within 14 days before randomisation.