Non-Squamous Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, NSCLC, Non-Squamous NSCLC, Telisotuzumab Adizutecan, ABBV-400, Cancer
Brief summary
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to evaluate whether telisotuzumab adizutecan improves response rate and overall survival compared to standard of care in participants with epidermal growth factor receptor (EGFR) wildtype non-squamous NSCLC who have high c-Met protein expression and have progressed after standard therapies. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This is an open-label study where participants and doctors know which treatment is being administered. Participants are randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan, while the other group will receive standard of care (SOC) treatment consisting of Docetaxel or Docetaxel with Ramucirumab. Around 660 participants will be enrolled in the study at approximately 250 sites worldwide. Participants will receive either doses of Intravenous (IV) telisotuzumab adizutecan or IV SOC of docetaxel alone or docetaxel with ramucirumab. The study will run for a duration of approximately 50 months. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Interventions
DRUGTelisotuzumab Adizutecan
Intravenous (IV)
DRUGDocetaxel
IV
DRUGRamucirumab
IV
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
* Histologically or cytologically confirmed metastatic/locally advanced non-squamous NSCLC * Known EGFR activating mutation status (EGFR wildtype only; participants with EGFR activating mutations are not eligible) * Cellular-mesenchymal epithelial transition (c-Met) Immunohistochemistry (IHC) staining as assessed by AbbVie designated IHC Laboratory * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 * At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 that has not been previously irradiated
Exclusion criteria
* Participant tumor(s) has (have) mixed adenosquamous or squamous or neuroendocrine histology or sarcomatoid features * Known active/symptomatic brain metastases * History of interstitial lung disease (ILD) or pneumonitis that required systemic steroids * Major, life-threatening medical conditions with life expectancy less than 3 months * Clinically significant medical conditions or other reasons that would interfere with study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to Approximately 24 Months | OR is defined as participants achieving a best overall response of confirmed complete response (CR) or partial response (PR) per BICR based on RECIST version 1.1. |
| Overall Survival (OS) | Up to Approximately 50 Months | OS is defined as the time from date of randomization to the event of death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) Based on BICR Assessment Per RECIST Version 1.1 | Up to Approximately 24 Months | PFS is defined as the time from date of randomization to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier. |
| Duration of Response (DoR) Based on BICR Assessment Per RECIST Version 1.1 | Up to Approximately 24 Months | DoR defined as time from the date of initial response of confirmed CR or PR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR. |
| Disease Control (DC) Based on BICR Assessment Per RECIST Version 1.1 | Up to Approximately 24 Months | DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, v1.1 |
| Change From Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | Up to Week 12 | The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much). |
| Change From Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Up to Week 12 | The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much). |
| Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) as Measured by the EORTC QLQ-C30 | Up to Week 12 | Health-related quality-of-life and symptoms will be assessed with the EORTC QLQ-C30. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a GHS/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much). |
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed