Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

  • End date
    Jan 16, 2025
  • participants needed
  • sponsor
Updated on 11 May 2022
AbbVie_Call Center
Primary Contact
Straub Clinic and Hospital /ID# 217905 (0.9 mi away) Contact
+198 other location
systemic therapy
growth factor
epidermal growth factor receptor
cancer treatment
cancer chemotherapy
epidermal growth factor
stage iv non-small cell lung cancer
lung carcinoma


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).

Condition Non-small Cell Lung Cancer
Treatment Telisotuzumab vedotin
Clinical Study IdentifierNCT03539536
Last Modified on11 May 2022


Yes No Not Sure

Inclusion 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 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same gene alteration count as 1 line of therapy for the purposes of this eligibility criterion

Exclusion 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
Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
History of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis
Participants do not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or interstitial lung disease within 3 months of the planned first dose of the study drug
Participants must not have received radiation therapy to the lung <6 months prior to the first dose of telisotuzumab vedotin
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