Study on Amivantamab with Tyrosine Kinase Inhibitors for Advanced Non-Small Cell Lung Cancer with ALK, ROS1, or RET Alterations

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05845671

Provider View

This clinical trial is exploring a new treatment combination using amivantamab and tyrosine kinase inhibitors (TKIs) for patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes (ALK, ROS1, or RET). The study aims to see if this combination can overcome resistance to current TKI therapies and improve treatment outcomes.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with advanced non-small cell lung cancer (NSCLC) who have specific genetic changes known as ALK, ROS1, or RET fusions. These patients often respond well to initial treatments with tyrosine kinase inhibitors (TKIs), but over time, the cancer can become resistant. This trial is investigating whether adding a drug called amivantamab to the TKI treatment can help overcome this resistance and improve the effectiveness of the therapy.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) with ALK, ROS1, or RET gene changes.
  • Have previously been treated with at least one FDA-approved TKI and experienced disease progression.
  • Have at least one measurable tumor that can be tracked using scans.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have a life expectancy of more than 12 weeks.
  • Be able to take oral medications.
  • Have completed any previous cancer treatments within specified timeframes before starting the study.
  • Have adequate organ function as determined by specific blood tests.
  • Women of childbearing potential must agree to use effective contraception and have a negative pregnancy test before starting the study.
  • Men must agree to use condoms and ensure their partners use effective contraception during the study and for 6 months after.
  • Agree not to donate eggs or sperm during the study and for 6 months after the last dose of study drug.

Exclusion Criteria

  • Have received an investigational drug or participated in another clinical trial within 28 days before starting the study.
  • Have previously received certain types of cancer treatments, such as EGFR or MET inhibitors.
  • Have progressed on a TKI in less than 8 weeks.
  • Have certain types of cancer cell changes or additional primary cancers within 2 years prior to enrollment.
  • Have active or untreated brain metastases or other central nervous system issues.
  • Have significant heart problems or uncontrolled high blood pressure.
  • Have a history of lung disease or gastrointestinal issues that could affect the study drug.
  • Have active infections like HIV, hepatitis B, or hepatitis C.
  • Be pregnant or breastfeeding.
  • Have a history of severe allergic reactions to study drugs.
  • Have any medical or psychiatric conditions that could interfere with the study.
  • Have received live vaccines within 30 days before starting the study.
  • Have not recovered from side effects of previous cancer treatments.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.