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Closed (no longer recruiting)Last updated: 31 January 2024

ALTA-2: This phase II trial is testing an oral anti-cancer therapy (Brigatinib) in patients who have ALK+ non-small cell lung cancerBrigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

Clinical summary

Summary

Participants in this trial will receive 90mg Brigatinib tablets, once a day for seven days, followed by 180mg Brigatinib tablets once a day until disease progression, as advised by the investigator, or toxicity occurs.

Conditions

This trial is treating patients with non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

ALTA-2

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

ARIAD Pharmaceuticals

Scientific Title

Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

Eligibility

Inclusion

  1. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent and not a participant for curative therapy) or stage IV non-small-cell lung cancer (NSCLC).
  2. Must meet both of the following 2 criteria:

    1. Have documentation of anaplastic lymphoma kinase (ALK) rearrangement by a positive result from any laboratory test® approved by the food and drug administration (FDA) or Have documented ALK rearrangement by a different test (non-FDA-approved local lab tests) and have provided tumor sample to the central laboratory. (Note: Central laboratory ALK rearrangement testing results are not required to be obtained before randomization.)
    2. Had been on any one of the ALK tyrosine kinase inhibitor (TKIs) (alectinib, ceritinib, crizotinib) for at least 12 weeks before progression.
  3. Had progressive disease (PD) while on alectinib or ceritinib
  4. Had alectinib or ceritinib as the most recent ALK inhibitor therapy.
  5. Have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
  6. Had recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE), version 4.03, Grade <=1. (Note: Treatment-related alopecia or peripheral neuropathy that are Grade >1 are allowed if deemed irreversible.) and have adequate major organ functions.
  7. Have a life expectancy of ≥3 months.

Exclusion

  1. Had received any prior ALK-targeted TKI other than crizotinib, alectinib, or ceritinib.
  2. Had received both alectinib and ceritinib.
  3. Had previously received more than 3 regimens of systemic anticancer therapy for locally advanced or metastatic disease.
  4. Had symptomatic brain metastasis (parenchymal or leptomeningeal). Participants with asymptomatic brain metastasis or who have stable symptoms that did not require an increased dose of corticosteroids to control symptoms in the past 7 days before the first dose of brigatinib may be enrolled.
  5. Had current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
  6. Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose of brigatinib.
  7. Had an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.
  8. Had malabsorption syndrome or other gastrointestinal (GI) illness that could affect oral absorption of brigatinib.

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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