Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, NSCLC, Telisotuzumab Vedotin, ABBV-399, TeliMET NSCLC-04
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 80 to 90 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.
Interventions
Intravenous (IV) Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Projected life expectancy of at least 12 weeks. * Must have c-Met overexpressing non-small cell lung cancer (NSCLC) (defined as \>= 25% tumor cells with 3+ staining (high \[\>= 50% 3+\]; intermediate \[\>= 25% - \< 50%\]) as assessed by a Sponsor 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.
Exclusion criteria
* Adenosquamous or neuroendocrine histology, or sarcomatoid features. * EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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) |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| Overall Survival (OS) | Up to Approximately 3 Years | OS will be defined as the time from randomization to death from any cause. |
Countries
Brazil, China, Israel, Japan, Serbia, Singapore, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed