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.
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
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
Parallel
Telisotuzumab Adizutecan
DrugIntravenous (IV)
Docetaxel
DrugIV
Ramucirumab
DrugIV
Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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)
OS is defined as the time from date of randomization to the event of death from any cause.
Progression-Free Survival (PFS) Based on BICR Assessment Per RECIST Version 1.1
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
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
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)
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).
This trial is not recruiting at the moment. You can still explore other options:
