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

Running, not enrolling · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress 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). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).

Key facts

Study ID

NCT03539536

Run by

AbbVie

People needed

270

Starts

2018-10-10

Expected to finish

2026-08-01

Last updated by the study team

2025-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have locally advanced or metastatic non-small cell lung cancer (NSCLC).
• Have 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 prescreening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, subject can submit fresh biopsy material for reassessment of c-Met expression.
• Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild type NSCLC (site documented EGFR status). Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is enrolling participants with non-squamous EGFR wild type NSCLC only.
• Must 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 tyrosine kinase (TK) count as 1 line of therapy for the purposes of this eligibility criterion.
• Progressed on systemic cytotoxic therapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible), and prior anticancer therapies targeting driver gene alterations (if applicable).
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• Treatment with any therapies within the noted time intervals is excluded prior to the first dose of telisotuzumab vedotin as noted in the protocol.
• Metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided within the protocol.

You may not qualify if…

• Have received radiation therapy to the lungs < 6 months prior to the first dose of telisotuzumab vedotin.
• Have received any live vaccine within 30 days of the first dose of investigational product.
• Has adenosquamous histology.
• Have a history of other malignancies except those noted within the protocol.
• Have a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids.
• Have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD within 3 months of the planned first dose of the study drug (Except for Sites in Ireland). For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
• For Sites in Ireland Only: Must not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD. For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
• Have a clinically significant condition(s) as noted in the protocol.
• Have unresolved clinically significant adverse events of Grade >= 2 from prior anticancer therapy, except for alopecia or anemia.
• Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
• For Sites in France and Czech Republic Only: Have the following:
• Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board.
• Active hepatitis B virus (HBV) infection, defined by hepatitis B surface antigen (HBsAg) positivity or HBV DNA >= 500 IU/mL. In participants with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening.
• Active hepatitis C virus (HCV) infection, defined by HCV ribonucleic acid (RNA) positivity. Participants cured of HCV infection may be included in the study. In participants with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening.
• Uncontrolled autoimmune disease.

Where it is running

• Mayo Clinic Arizona /ID# 218550 — Phoenix, Arizona, United States
• Highlands Oncology Group, PA /ID# 215600 — Springdale, Arkansas, United States
• University of California, Los Angeles /ID# 203219 — Los Angeles, California, United States
• LA Hematology-Oncology Med Group /ID# 203338 — Orange, California, United States
• Sutter Medical Center Sacramen /ID# 203299 — Sacramento, California, United States
• Icri /Id# 227835 — Whittier, California, United States
• Univ of Colorado Cancer Center /ID# 203212 — Aurora, Colorado, United States
• Duplicate_Rocky Mountain Cancer Centers - Lone Tree /ID# 215789 — Lone Tree, Colorado, United States
• Advanced Cancer Treatment Center /ID# 239565 — Brooksville, Florida, United States
• AdventHealth Celebration /ID# 215649 — Celebration, Florida, United States
• Duplicate_Mayo Clinic /ID# 218488 — Jacksonville, Florida, United States
• Duplicate_AdventHealth Cancer Institute - Orlando /ID# 239960 — Orlando, Florida, United States
• Straub Clinic and Hospital /ID# 217905 — Honolulu, Hawaii, United States
• Northwestern University Feinberg School of Medicine /ID# 203239 — Chicago, Illinois, United States
• The University of Chicago Medical Center /ID# 203216 — Chicago, Illinois, United States
• Duplicate_NorthShore University HealthSystem /ID# 215583 — Evanston, Illinois, United States
• Ingalls Memorial Hosp /ID# 203228 — Harvey, Illinois, United States
• Joliet Oncology-Hematology Associates, LTD /ID# 203238 — Joliet, Illinois, United States
• Goshen Center for Cancer Care /ID# 215584 — Goshen, Indiana, United States
• Univ Kansas Med Ctr /ID# 216804 — Kansas City, Kansas, United States
• Cancer Center of Kansas /ID# 203235 — Wichita, Kansas, United States
• Duplicate_Baptist Health /ID# 203283 — Lexington, Kentucky, United States
• Duplicate_Norton Cancer Institute - St Matthews /ID# 203284 — Louisville, Kentucky, United States
• Central Maine Medical Center /ID# 216583 — Lewiston, Maine, United States
• University of South Alabama /ID# 212939 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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