Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein

Sponsor
AbbVie
Study ID
NCT06093503
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telisotuzumab Vedotin — DRUG
    Intravenous (IV) Infusion
  • Osimertinib — DRUG
    Oral: Tablet
  • Cisplatin — DRUG
    IV Infusion
  • Carboplatin — DRUG
    IV Infusion
  • Pemetrexed — DRUG
    IV Infusion

Study Details

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how telisotuzumab vedotin in combination with osimertinib affects the disease state compared to standard of care in adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the epidermal growth factor receptor (EGFR) gene and that overexpresses the c-Met protein. Change in disease activity will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC that overexpresses the c-Met protein. Participants are randomly placed in one of the two groups to receive telisotuzumab vedotin and osimertinib or standard of care chemotherapy. Approximately 250 adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the EGFR gene and that overexpresses the c-Met protein will be enrolled in the study in approximately 180 sites worldwide. Participants will receive intravenous telisotuzumab vedotin every 2 weeks in combination with oral osimertinib tablets daily or standard of care chemotherapy (carboplatin/pemetrexed or cisplatin/pemetrexed as prescribed by the physician). Overall duration of the study is estimated to be approximately 47 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key Dates

Start date
May 31, 2024
Status verified
Jun 2024
Primary completion
Apr 11, 2028
Completion
Apr 11, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telisotuzumab Vedotin and Osimertinib
    Participants will receive telisotuzumab vedotin every 2 weeks in combination with osimertinib, until disease progression or unacceptable toxicity.
  • Experimental: Standard of Care
    Participants will receive standard of care chemotherapy (carboplatin/pemetrexed or cisplatin/pemetrexed as prescribed by the physician), until disease progression or unacceptable toxicity.

Primary Outcome Measure

PFS in the Population of Participants with no Central Nervous System (CNS) Metastases at Baseline [ Time Frame: Up to Approximately 41 Months ]

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