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Abbvie M14-239: A Phase 2, open-label safety and efficacy study of telisotuzumab vedotin (ABBV-399) in subjects with previously treated c-Met+ non-small cell lung cancer

Description

This study is designed to identify the target non-small cell lung cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (stage 2).

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this trial is to determine the overall response rate.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who meet these criteria:

  • Histologically confirmed non-squamous cell non-small cell lung cancer (NSCLC) with known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site documented status). Of note, participants with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met.
  • Has locally advanced or metastatic NSCLC.
  • Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. Participant must submit archival or fresh tumor material for assessment of c-Met levels during the pre-screening period. If archival tissue is c-Met negative, participant can submit fresh biopsy material for reassessment of c-Met expression.
  • Have received no more than two lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting.
    • Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same gene alteration count as one line of therapy for the purposes of this eligibility criterion.
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Excluding patients who meet these criteria:

  • Have received prior c-Met-targeted antibody-based therapies.
  • Has adenosquamous histology.
  • Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy).
  • Has a clinically significant condition(s) described in the protocol.
  • Has unresolved clinically significant adverse events >= grade 2 from prior anticancer therapy, except for alopecia or anemia.
  • Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • Has received live vaccine within 30 days of the first dose of telisotuzumab vedotin.
  • History of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.
  • Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
  • Participants do not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or interstitial lung disease within three months of the planned first dose of the study drug.
  • Participants must not have received radiation therapy to the lung less than six months prior to the first dose of telisotuzumab vedotin.
     

Accepting new patients

 

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