Ended Therapeutic exploratory (Phase II) Non-small cell lung cancer (NSCLC)

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.

EU CTIS ID: 2022-502467-38-00

What this study is testing

The primary objective of this trial is to evaluate the efficacy in terms of progression-free survival (PFS) for brigatinib consolidation compared to observation/durvalumab, in patients with unresectable stage III NSCLC and ALK-rearrangement, who completed definitive chemo-radiotherapy without disease progression. Secondary measures of clinical efficacy will be evaluated, including overall survival (OS), CNS-relapse-free survival, patterns of disease progression, and safety.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom
  • Switzerland

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; Switzerland. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.