Telisotuzumab Adizutecan with Osimertinib for Lung Cancer

A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Recruiting Phase 2 Phase 3 Interventional Study
Non-Squamous Non-Small Cell Lung Cancer c-MET
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
854 (estimated)
Sponsor
AbbVie · Industry
Who this trial is looking for

This trial is looking for adults with a specific type of lung cancer called non-squamous NSCLC. Participants will receive a combination of two treatments to see how they affect the disease and any side effects.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with non-squamous non-small cell lung cancer.
  • I have a performance status of 0 or 1.
  • I can provide recent tumor tissue for testing.
  • I have at least one measurable tumor that has not been irradiated.
  • I have resolved any side effects from past cancer treatments.
  • I am expected to live at least 3 more months.
  • I have a specific type of mutation in my lung cancer.
  • I have not taken certain lung cancer medications recently.

You may not be able to join if

  • I have a history of interstitial lung disease or pneumonitis.
  • I have spinal cord compression that has not been treated.
  • I have had another cancer that is not my lung cancer, unless it was treated successfully and I have been cancer-free for at least 2 years.
  • I have received treatment for leptomeningeal disease.
  • I have a history of certain types of lung disease.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy). Telisotuzumab adizutecan is an inv…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1. * Must consent to provide recently obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue (ideally collected…
Contacts

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