NCT07821684Not yet recruitingPhase 3
A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants Previously Treated, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
A Phase 3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Previously Treated, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer Expressing c-Met Protein Level Above a Defined Cutoff
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 660 (estimated)
- First submitted
- 10 Sept 2026
- Start date
- 6 Jan 2027
- Primary completion date
- Mar 2030
- Lead sponsor
- AbbVie
- Diseases
- Lung cancer
- NCT number
- NCT07821684
- EU CT number
- 2025-524802-13-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 660
- From 6 Jan 2027 to the primary completion date, Mar 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Participant tumor(s) has (have) mixed adenosquamous or squamous or neuroendocrine histology or sarcomatoid features
- Known active/symptomatic brain metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.