A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
- Registration Number
- NCT06568939
- Lead Sponsor
- AbbVie
- Brief Summary
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 assess how safe telisotuzumab vedotin is in adult participants with NSCLC. 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 in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 70 to 80 sites worldwide.
Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Projected life expectancy of at least 12 weeks.
- Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory
- Must have histologically or cytologically documented NSCLC that is locally advanced or metastatic.
- Must have a known epidermal growth factor receptor (EGFR) activating mutation status.
- Actionable alterations in genes other than EGFR are permitted.
- Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting, as stated in the protocol.
- Must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC, as stated in the protocol.
- Adenosquamous or neuroendocrine histology, or sarcomatoid features.
- Actionable EGFR activating mutations.
- Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.
- Received prior docetaxel therapy.
- Metastases to the central nervous system (CNS). Participants with CNS metastases are eligible only after adequate treatment (such as surgery or, radiotherapy, or drug therapy) is provided, as stated on the protocol.
- History of other malignancies except those stated in the protocol.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan, as noted in the protocol.
- Unresolved clinically significant 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) including but not limited to those listed in the protocol.
- Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.
- Grade >= 2 edema or lymphedema.
- Grade >= 2 ascites or pleural effusion.
- Grade >= 2 neuropathy.
- Active uncontrolled bacterial or viral infection.
- Active corneal disorder.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telisotuzumab Vedotin Dose A Telisotuzumab Vedotin Participants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration. Telisotuzumab Vedotin Dose B Telisotuzumab Vedotin Participants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration. Telisotuzumab Vedotin Dose C Telisotuzumab Vedotin Participants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2) Up to Approximately 3 Years An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Percentage of Participants with Treatment-Emergent Interstitial Lung Disease (ILD) Up to Approximately 3 Years ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication (any-grade and Grade \>= 2).
Objective Response (OR) by Blinded Independent Central Review (BICR) Up to Approximately 3 Years OR will be defined as achieving confirmed complete response (CR) or confirmed partial response (PR) based on response evaluation criteria in solid tumors (RECIST), version 1.1.
Percentage of Participants with Treatment-Emergent Ocular Surface Disorders Up to Approximately 3 Years Treatment-emergent ocular surface disorders defined by corneal epitheliopathy company MedDRA query (CMQ) (any-grade and Grade \>= 2).
Percentage of Participants with Treatment-Emergent AEs Leading to Study Drug Discontinuation Up to Approximately 3 Years An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Percentage of Participants with Grade 5 Treatment-Emergent AEs Up to Approximately 3 Years An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Percentage of Participants with Treatment-Emergent Peripheral Neuropathy Up to Approximately 3 Years Peripheral neuropathy is defined by peripheral neuropathy SMQ (narrow) (any-grade and Grade \>= 2)
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) by BICR Up to Approximately 3 Years PFS will be defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause.
Concentrations of Telisotuzumab Vedotin Conjugate in Serum Up to 26 Weeks Concentrations of telisotuzumab vedotin conjugate in serum.
Concentrations of Monomethylauristatin E (MMAE) Payload in Plasma Up to 26 Weeks Concentrations of MMAE payload in plasma.
Percentage of Participants with Antidrug Antibodies (ADAs) of Telisotuzumab Vedotin Up to 26 Weeks Percentage of participants with ADAs of telisotuzumab vedotin.
Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G) Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years The GP5 item ("I am bothered by side effects of treatment") of FACT-G is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on participants.
Duration of Response (DoR) by BICR Up to Approximately 3 Years DoR is defined for confirmed responders as the time from the participants' initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause.
Percentage of Participants with Neutralizing Antidrug Antibodies (nADAs) of Telisotuzumab Vedotin Up to 26 Weeks Percentage of participants with nADAs of telisotuzumab vedotin.
Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in patients participating in cancer clinical trials. PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0/1 for absent/present).
Overall Survival (OS) Up to Approximately 3 Years OS will be defined as the time from randomization to death from any cause.
Trial Locations
- Locations (21)
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
🇺🇸Omaha, Nebraska, United States
Cancer Care Associates Of York /ID# 270971
🇺🇸York, Pennsylvania, United States
SCRI Oncology Partners /ID# 270162
🇺🇸Nashville, Tennessee, United States
Texas Oncology - Northeast Texas /ID# 272000
🇺🇸Tyler, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 272004
🇺🇸Fairfax, Virginia, United States
Union Hospital - Tongji Medical College /ID# 271668
🇨🇳Wuhan, Hubei, China
National University Hospital /ID# 271700
🇸🇬Singapore, Singapore
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
🇺🇸Jacksonville, Florida, United States
Comprehensive Hematology Oncology /ID# 270422
🇺🇸Saint Petersburg, Florida, United States
Springfield Clinic /ID# 272576
🇺🇸Springfield, Illinois, United States
Astera Cancer Care /ID# 272359
🇺🇸East Brunswick, New Jersey, United States
Clinical Research Alliance - Westbury /ID# 270455
🇺🇸Westbury, New York, United States
FirstHealth of the Carolinas- Speciality Center /ID# 272924
🇺🇸Pinehurst, North Carolina, United States
Genesis Healthcare System /ID# 273361
🇺🇸Zanesville, Ohio, United States
Guthrie Robert Packer Hospital /ID# 270316
🇺🇸Sayre, Pennsylvania, United States
Northwest Medical Specialties Tacoma /ID# 270534
🇺🇸Tacoma, Washington, United States
Rambam Health Care Campus /ID# 270078
🇮🇱Haifa, H_efa, Israel
Meir Medical Center /ID# 270071
🇮🇱Kfar Saba, HaMerkaz, Israel
Shaare Zedek Medical Center /ID# 270095
🇮🇱Jerusalem, Israel
Rabin Medical Center /ID# 270087
🇮🇱Petah Tikva, Israel
National Cancer Centre Singapore /ID# 271499
🇸🇬Singapore, Central Singapore, Singapore