Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small CellLung Cancer

Phase 1

• Conditions: on-Small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001772-38-IT
• Lead Sponsor: ABBVIE DEUTSCHLAND GMBH & CO. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 7 September 2021

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.
• If a subject meets eligibility criteria for c-Met protein expression level based on archival tissue material, subject must agree to submit fresh tumor material for assessment of c-Met protein expression level prior to first dose of telisotuzumab vedotin
• Subjects who have progressed on systemic cytotoxic chemotherapy (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).
• 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.
• Has known uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible if they meet requirements described in the protocol.
• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to determine the overall response rate (ORR) of telisotuzumab vedotin in subjects with c-Met+ NSCLC.;Secondary Objective: The secondary objectives are to determine Duration of response (DoR), Disease control rate (DCR), Duration of disease control (DDC), Progression Free Survival (PFS), Overall Survival (OS), Safety and Tolerability.;Primary end point(s): Overall Response Rate (ORR);Timepoint(s) of evaluation of this end point: Overall response rate assessed by an independent central review according to RECIST, version 1.1.10 ORR will be defined as the proportion of subjects with a confirmed complete response (CR) or confirmed partial response (PR) based on RECIST, version 1.1.