Featured Trial

A Phase 2/3, Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects with Locally Advanced or Metastatic EGFR‑Mutated Non‑Squamous Non‑Small Cell Lung Cancer After Progression on a Third‑Generation EGFR TKI - AndroMETa‑Lung‑713

Study Identifier
M25-713
CT.gov Identifier
NCT07155187
EudraCT Identifier
Not available
EUCTIS ID
2025-521124-29
For general inquiries, please contact

844-663-3742 or [email protected]

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Study Details

The AndroMETa-Lung-713 Study is looking for adults with lung cancer, whose cancer is either locally advanced (grown outside where it started but not spread far) or metastatic (spread to other parts of the body) and whose cancer cells have changes (mutations) in a protein called EGFR. EGFR normally helps control how cells grow, but when it’s changed, it can make cancer cells grow and spread quickly.

The AndroMETa-Lung-713 Study is evaluating an investigational treatment, telisotuzumab adizutecan (also called ABBV-400 or Temab-A). Temab-A is a type of cancer treatment called an antibody-drug conjugate (ADC). It combines an antibody with a cancer drug. The antibody recognizes and attaches to a protein called c-Met, which is present on some cancer cells. Once attached, the ADC enters the cancer cells, and delivers a drug that interferes with the cell's ability to repair itself, causing it to die.

The investigational treatment, Temab-A (telisotuzumab adizutecan), is under clinical development and is not currently approved for use in cancer by regulatory health authorities. Safety, tolerability, and effectiveness are under evaluation.

Study Details

Medical Condition
  • Lung Cancer - Non-Small Cell Lung Cancer (NSCLC)
    • Study Drug
  • Telisotuzumab Adizutecan
  • Standard of Care
    • Phase
    Phase 2/Phase 3
    Estimated Enrollment
    430 patients

    Participating in our Non-Small Cell Lung Cancer Clinical Trials

    During the initial phase of the study, participants will receive one of two possible doses of the investigational treatment telisotuzumab adizutecan (ABBV-400 or Temab-A), which will be given as an intravenous infusion (delivered through a tube into the vein or into a catheter that you might already have in place). Patients will visit the study clinic once a week for approximately the first four weeks and then every 3 weeks until study treatment discontinuation criteria are met. The study doctor will monitor the effect of the investigational treatment on the cancer. The disease will be regularly evaluated by the study doctor using imaging (CT/MRI). The total study duration will depend on each participant’s response to their study treatment.

    In a later study phase, researchers will compare an optimized dose of the study drug to an existing standard of care treatment, such as chemotherapy, for patients with advanced or metastatic EGFR-mutated non-squamous NSCLC.

    Study Participant Requirements

    Sex
    Female & Male
    Age
    18+ years

    Key Inclusion and Exclusion Criteria

    Participants must:

    • Be at least 18 years old.
    • Have been diagnosed with locally advanced or metastatic, EGFR-mutated non-squamous NSCLC:
      • Locally advanced: Your cancer has grown outside the area where it started but hasn’t yet spread to other parts of your body.
      • Metastatic: Your cancer has spread to other parts of your body.
      • EGFR: Epidermal growth factor receptor (EGFR) is a protein that helps cancer cells grow. When mutated, it can lead to uncontrolled cell growth and tumor development.
    • Have progressed on prior EGFR therapy.

    Participants must not:

    • Have a history of serious lung conditions like interstitial lung disease or pneumonitis.
    • Have untreated or unstable brain or spinal cord cancer.
    • Be pregnant or breastfeeding.
    • Have allergies to the study drugs or their ingredients.

    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation. * Provide archived or recently obtained tumor tissue during Screening. * Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated. * Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment. * Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded. * If the prior third-generation EGFR TKI was administered in the adjuvant setting, progression must have occurred while on treatment.
    Exclusion Criteria:
    * Tumor(s) have adenosquamous or squamous histology or sarcomatoid features. * Received more than 1 line of systemic therapy in the locally advanced or metastatic setting. * Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.

    Study Locations

    Location
    Status
    Location
    Highlands Oncology Group - Springdale /ID# 277132
    Springdale, Arkansas, United States, 72762
    Status
    Recruiting
    Location
    Cancer Care Centers of Brevard- Rockledge /ID# 277853
    Rockledge, Florida, United States, 32955
    Status
    Recruiting
    Location
    HealthPartners Cancer Research Center /ID# 277339
    Saint Louis Park, Minnesota, United States, 55426
    Status
    Recruiting
    Location
    Nho - Revive Research Institute /ID# 277569
    Lincoln, Nebraska, United States, 68506
    Status
    Recruiting
    Location
    Astera Cancer Care /ID# 277570
    East Brunswick, New Jersey, United States, 08816-4096
    Status
    Recruiting
    Location
    Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
    Knoxville, Tennessee, United States, 37909
    Status
    Recruiting
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