A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin or docetaxel at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 768 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 330 sites worldwide.
Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. At the conclusion of the study, participants who continue to demonstrate clinical benefit may be eligible to receive study treatment via an extension of the study, a rollover study, or through another mechanism.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Projected life expectancy of at least 12 weeks.
* Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
* Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.
* If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
* A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
* A known epidermal growth factor receptor (EGFR) activating mutation status.
\-- Participants with EGFR activating mutations are not eligible
* Actionable alterations in genes other than EGFR are eligible.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
* Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC
* Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
* Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase \[ALK\] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.
* Participants with gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
* Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
* Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:
* They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day \[QD\] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.
Exclusion Criteria:
* Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.
* Evidence of leptomeningeal disease.
* Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
* Epidermal growth factor receptor (EGFR) activating mutations.
* Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
* Participants who have received prior docetaxel therapy.
* A history of other malignancies except:
* Malignancy treated with curative intent and with no known active disease present for \>=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. Additionally, participants must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization..
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated carcinoma in situ without current evidence of disease.
* A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed tomography (CT) scan or prior pneumonectomy. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
* Unresolved nor adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
* Major surgery within 21 days prior to randomization.
* Clinically significant condition(s) as listed in the protocol.
Primary outcome measure(s)
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) — Up to approximately 39 months PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per BICR or death from any cause.
Overall Survival (OS) — Up to approximately 39 months OS is defined as the time from randomization to the event of death from any cause.
Trial sites (317)
Facility
City
Region
Status
University of Alabama at Birmingham - Main /ID# 247074
Birmingham
Alabama
Completed
Ironwood Cancer & Res Ctr /ID# 262446
Chandler
Arizona
Active Not Recruiting
Mayo Clinic Arizona /ID# 255858
Phoenix
Arizona
Active Not Recruiting
Onvida Health Yuma Medical Center /ID# 253625
Yuma
Arizona
Completed
City of Hope /ID# 243157
Duarte
California
Recruiting
City Of Hope - Seacliff /ID# 263143
Huntington Beach
California
Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144
Irvine
California
Recruiting
City Of Hope - Antelope Valley /ID# 263138
Lancaster
California
Recruiting
The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774
Los Angeles
California
Completed
Eisenhower Medical Center /ID# 233189
Rancho Mirage
California
Completed
Premiere Oncology Foundation /ID# 253954
Santa Monica
California
Completed
Mayo Clinic Hospital Jacksonville /ID# 254688
Jacksonville
Florida
Completed
Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228
Ocala
Florida
Completed
BRCR Medical Center Inc /ID# 262344
Tamarac
Florida
Completed
Memorial University Medical Center /ID# 264081
Savannah
Georgia
Completed
Kaiser Permanente Moanalua Medical Center /ID# 238363
Honolulu
Hawaii
Recruiting
Edward-Elmhurst Cancer Center /ID# 238552
Elmhurst
Illinois
Active Not Recruiting
Springfield Clinic - First /ID# 262290
Springfield
Illinois
Active Not Recruiting
Goshen Center for Cancer Care /ID# 257734
Goshen
Indiana
Completed
Investigative Clinical Research of Indiana - Indianapolis /ID# 260468
Indianapolis
Indiana
Completed
Baptist Health Lexington /ID# 252769
Lexington
Kentucky
Completed
Dana-Farber Cancer Institute /ID# 247132
Boston
Massachusetts
Completed
Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190
Ypsilanti
Michigan
Completed
Mayo Clinic - Rochester /ID# 252052
Rochester
Minnesota
Active Not Recruiting
Hattiesburg Clinic /ID# 248033
Hattiesburg
Mississippi
Recruiting
St. Luke's Hospital - Chesterfield /ID# 251688
Chesterfield
Missouri
Completed
St. Lukes Hosp. of Kansas City /ID# 259940
Kansas City
Missouri
Recruiting
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567
Kansas City
Missouri
Completed
Hulston Cancer Center /ID# 232226
Springfield
Missouri
Recruiting
Saint Louis University Cancer Center /ID# 260722
St Louis
Missouri
Completed
Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147
Billings
Montana
Active Not Recruiting
Nebraska Hematology Oncology /ID# 257710
Lincoln
Nebraska
Completed
Renown Medical Group - Oncology/Hematology /ID# 247942
Reno
Nevada
Completed
Astera Cancer Care /ID# 257753
East Brunswick
New Jersey
Completed
San Juan Oncology Associates /ID# 244387
Farmington
New Mexico
Completed
Maimonides Medical Center /ID# 240783
Brooklyn
New York
Active Not Recruiting
Northwell Health - Monter Cancer Center /ID# 247081
Lake Success
New York
Completed
AdventHealth Hendersonville /ID# 265349
Hendersonville
North Carolina
Completed
FirstHealth of the Carolinas- Speciality Center /ID# 241279
Pinehurst
North Carolina
Completed
Genesis Cancer Care Center /ID# 239190
Zanesville
Ohio
Active Not Recruiting
+ 277 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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