Clinical Trials /

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

NCT03539536

Description:

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).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: M14-239
  • SECONDARY ID: 2018-001772-38
  • NCT ID: NCT03539536

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
Telisotuzumab vedotinABBV-399Telisotuzumab vedotin

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Telisotuzumab vedotinExperimentalTelisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
  • Telisotuzumab vedotin

Eligibility Criteria

        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.

               -  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.

        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.

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Secondary Outcome Measures

Measure:Duration of Response (DoR)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:DoR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression determined by an independent central review or death from any cause for the responders.
Measure:Disease Control Rate (DCR)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:DCR is defined as the percentage of participants with best overall response of confirmed CR, confirmed PR, or stable disease (SD) for at least 12 weeks following enrollment, based on RECIST, version 1.1.
Measure:Progression-Free Survival (PFS)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:PFS is defined as the time from the participant's first dose of study drug until the first occurrence of radiographic progression determined by an independent central review or death from any cause.
Measure:Overall Survival (OS)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:OS is defined as the time from the participant's first dose of study drug until death from any cause.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Non-small Cell Lung Cancer (NSCLC)
  • Cancer
  • Telisotuzumab vedotin
  • ABBV-399
  • c-Met, c-Met overexpression
  • metastatic
  • MET gene amplification

Last Updated

August 19, 2021