Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer
- Conditions
- on Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080224062
- Lead Sponsor
- AbbVie GK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 35
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 prior systemic cytotoxic chemotherapy) in the locally advanced or 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
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- 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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Overall Response Rate (ORR)
- Secondary Outcome Measures
Name Time Method efficacy<br>- Duration of Response (DoR)<br>- Disease Control Rate (DCR)<br>- Progression-Free Survival (PFS)<br>- Overall Survival (OS)