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)

Recruiting · NCT04928846 · Interventional (participants receive a specific treatment)

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Interventions studied

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 29 US states.

University of Alabama at Birmingham - Main /ID# 247074 - Birmingham, Alabama, United States
Ironwood Cancer & Res Ctr /ID# 262446 - Chandler, Arizona, United States
Mayo Clinic Arizona /ID# 255858 - Phoenix, Arizona, United States
Onvida Health Yuma Medical Center /ID# 253625 - Yuma, Arizona, United States
City of Hope /ID# 243157 - Duarte, California, United States
City Of Hope - Seacliff /ID# 263143 - Huntington Beach, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144 - Irvine, California, United States
City Of Hope - Antelope Valley /ID# 263138 - Lancaster, California, United States
The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774 - Los Angeles, California, United States
Eisenhower Medical Center /ID# 233189 - Rancho Mirage, California, United States
Premiere Oncology Foundation /ID# 253954 - Santa Monica, California, United States
Mayo Clinic Hospital Jacksonville /ID# 254688 - Jacksonville, Florida, United States
Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228 - Ocala, Florida, United States
BRCR Medical Center Inc /ID# 262344 - Tamarac, Florida, United States
Memorial University Medical Center /ID# 264081 - Savannah, Georgia, United States
Kaiser Permanente Moanalua Medical Center /ID# 238363 - Honolulu, Hawaii, United States
Edward-Elmhurst Cancer Center /ID# 238552 - Elmhurst, Illinois, United States
Springfield Clinic - First /ID# 262290 - Springfield, Illinois, United States
Goshen Center for Cancer Care /ID# 257734 - Goshen, Indiana, United States
Investigative Clinical Research of Indiana - Indianapolis /ID# 260468 - Indianapolis, Indiana, United States
Baptist Health Lexington /ID# 252769 - Lexington, Kentucky, United States
Dana-Farber Cancer Institute /ID# 247132 - Boston, Massachusetts, United States
Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190 - Ypsilanti, Michigan, United States
Mayo Clinic - Rochester /ID# 252052 - Rochester, Minnesota, United States
Hattiesburg Clinic /ID# 248033 - Hattiesburg, Mississippi, United States
St. Luke's Hospital - Chesterfield /ID# 251688 - Chesterfield, Missouri, United States
St. Lukes Hosp. of Kansas City /ID# 259940 - Kansas City, Missouri, United States
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567 - Kansas City, Missouri, United States
Hulston Cancer Center /ID# 232226 - Springfield, Missouri, United States
Saint Louis University Cancer Center /ID# 260722 - St Louis, Missouri, United States
Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147 - Billings, Montana, United States
Nebraska Hematology Oncology /ID# 257710 - Lincoln, Nebraska, United States
Renown Medical Group - Oncology/Hematology /ID# 247942 - Reno, Nevada, United States
Astera Cancer Care /ID# 257753 - East Brunswick, New Jersey, United States
San Juan Oncology Associates /ID# 244387 - Farmington, New Mexico, United States
Maimonides Medical Center /ID# 240783 - Brooklyn, New York, United States
Northwell Health - Monter Cancer Center /ID# 247081 - Lake Success, New York, United States
AdventHealth Hendersonville /ID# 265349 - Hendersonville, North Carolina, United States
FirstHealth of the Carolinas- Speciality Center /ID# 241279 - Pinehurst, North Carolina, United States
Genesis Cancer Care Center /ID# 239190 - Zanesville, Ohio, United States
Cancer Care Associates Of York /ID# 266143 - York, Pennsylvania, United States
Medical University of South Carolina /ID# 251383 - Charleston, South Carolina, United States
St Francis Cancer Center /ID# 243596 - Greenville, South Carolina, United States
Avera Cancer Institute - Aberdeen /ID# 257759 - Aberdeen, South Dakota, United States
Avera Cancer Institute /ID# 239635 - Sioux Falls, South Dakota, United States
Duplicate_Memphis VA Medical Center /ID# 263250 - Memphis, Tennessee, United States
Dell Seton Medical Center /ID# 247016 - Austin, Texas, United States
Community Cancer Trials of Utah - South Ogden /ID# 262829 - Ogden, Utah, United States
Valley Medical Center /ID# 253950 - Renton, Washington, United States
Medical Oncology Associates /ID# 247003 - Spokane, Washington, United States
Jeroen Bosch Ziekenhuis /ID# 234087 - 's-Hertogenbosch, Netherlands
Adana Sehir Egitim ve Arastirma Hastanesi /ID# 255638 - Adana, Turkey (Türkiye)
Adana Acıbadem Hospital /ID# 234208 - Adana, Turkey (Türkiye)
Medical Park Seyhan Hastanesi /ID# 255637 - Adana, Turkey (Türkiye)
Institut Jules Bordet /ID# 246770 - Anderlecht, Belgium
Gazi Universitesi /ID# 265425 - Ankara, Turkey (Türkiye)
Ankara City Hospital /ID# 234210 - Ankara, Turkey (Türkiye)
UOMi Cancer Center - Clinica Tres Torres /ID# 240584 - Barcelona, Spain
Hospital Universitario Dexeus - Grupo Quironsalud /ID# 255105 - Barcelona, Spain
I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696 - Bari, Italy

Showing 60 of 317 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →