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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 310

Inclusion Criteria

• Histologically confirmed 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.
• 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.
• Subjects with no documented MET gene amplification must submit archival or fresh tumor material for assessment of c-Met levels by an AbbVie designated IHC laboratory during the Pre-Screening period. If a subject meets eligibility criteria for c-Met protein expression level based on archival tumor material, subject must agree to submit fresh tumor material for assessment of c-Met protein expression level prior to enrolment.
• Subjects with known documented MET gene amplification may prescreen. Archival or fresh tumor material (obtained at the same time as, or after, determination of MET amplification status) will need to be collected for testing of c-Met protein expression level by an AbbVie designated IHC laboratory prior to enrolment.
• Subjects who have progressed on systemic cytotoxic chemotherapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible for an immune checkpoint inhibitor), and prior anti-cancer therapies targeting driver gene alterations (if applicable).
• Subject must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of prior systemic cytotoxic chemotherapy) in the metastatic setting.
• Subjects should not have received prior cMET-targeted antibody-based therapies.
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 155
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 155

Exclusion Criteria

• Has adenosquamous histology.
• Has received anti-cancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy as described in the protocol.
• Subjects with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and:
? - There is no evidence of progression of CNS metastases at least 4 weeks after definitive therapy.
? - They are asymptomatic and off systemic steroids and anticonvulsants for at least 2 weeks prior to first dose of telisotuzumab vedotin.
• 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.
• Subject must 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.
• Subjects must not have received any live vaccine within 30 days of the first dose of investigational product.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

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

RecruitingPhase 2

AbbVie GK

Updated 10/17/2023