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
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).
18 Years and up
Accepting Healthy Volunteers?
- 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), or histologically documented squamous cell NSCLC. Of note, subjects 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 or known documented MET gene amplification.
- If a subject meets eligibility criteria for c-Met protein expression level based on archival tissue material, or MET amplification status, subject must agree to submit tumor material for assessment of c-Met protein expression level prior to enrollment.
- Has progressed on systemic cytotoxic therapy (or ineligible), and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible) and prior anti-cancer therapies targeting driver gene alterations (if applicable).
- Have received no more than 2 lines of prior systemic chemotherapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the metastatic setting.
- 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.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Has adenosquamous histology.
- Subjects 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.
- Subjects do not have a history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.