Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Recruiting
Sponsor: AbbVie
Collaborators:
Information provided by (Responsible party):
Sponsor
ClinicalTrials.gov Identifier: NCT03539536
Protocol Info
| Short Description: |
Phase 2 Telisotuzumab Vedotin in Previously Treated C-MET+ NSCLC |
| Long Description: |
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 |
| MGH Status: |
Open |
| Sponsor: |
AbbVie |
| Disease Program: |
Thoracic |
Next Steps
If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.
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).
| Condition Title |
Intervention |
Phase |
| Non-small Cell Lung Cancer
|
Telisotuzumab vedotin
|
Phase 2 |
| Study Type |
Interventional |
| 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 |
Primary Outcome Measures
Overall Response Rate (ORR) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]
Secondary Outcome Measures
Duration of Response (DoR) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]
Disease Control Rate (DCR) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]
Duration of Disease Control (DDC) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]
Progression-Free Survival (PFS) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]
Overall Survival (OS) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]
| Estimated Enrollment: |
310 |
| Study Start Date: |
October 2018 |
| Estimated Study Completion Date: |
August 2023 |
| Estimated Primary Completion Date: |
October 2021 |
| Arms |
Assigned Interventions |
Experimental:Telisotuzumab vedotin
Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
|
Drug:Telisotuzumab vedotin intravenous |
Eligibility
Ages Eligible for Study: N/A-N/A
Genders Eligible for Study: All
Accepts Healthly Volunteers: No
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), 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.
Exclusion Criteria:
- • 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.
More Information
No publications provided
| Responsible Party: |
Sponsor
|
| ClinicalTrials.gov Identifier: |
NCT03539536 |
| Other Study ID Numbers: |
2018-001772-38 |
| Study First Received: |
|
| Last Updated: |
|
| Health Authority: |
|
Keywords provided by AbbVie:
Non-small Cell Lung Cancer (NSCLC)
Cancer
Telisotuzumab vedotin
ABBV-399
c-Met, c-Met overexpression
metastatic
MET gene amplification
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Next Steps
If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.
ClinicalTrials.gov processed this data on January 20, 2021