A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination with Osimertinib as First-Line Treatment in Adult Participants with Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Key facts
- Where
- Barcelona, L'Hospitalet de Llobregat, Madrid és Valencia, SpanyolországSee the 5 sites
- Phase
- 2/3. fázis
Where in Spanyolország
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpanyolországTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországTaking people
- Hospital Universitario 12 de OctubreMadrid, SpanyolországTaking people
- Fundación Instituto Valenciano de OncologíaValencia, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie Deutschland GmbH & Co. KG
- Trial code
- EU 2024-518586-10-00
- Record updated
- 2026. április 14.
- Original description
Phase 2: - To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with osimertinib. - To optimize and select the RP3D of telisotuzumab adizutecan in combination with osimertinib. - To evaluate the efficacy as measured by ORR of telisotuzumab adizutecan in combination with osimertinib. Phase 3: To demonstrate the superiority of telisotuzumab adizutecan in combination with osimertinib over standard of care in terms of efficacy measured by PFS based on BICR assessment.Read full original descriptionShow less
A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination with Osimertinib as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Phase 2: - To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with osimertinib. - To optimize and select the RP3D of telisotuzumab adizutecan in combination with osimertinib. - To evaluate the efficacy as measured by ORR of telisotuzumab adizutecan in combination with osimertinib. Phase 3: To demonstrate the superiority of telisotuzumab adizutecan in combination with osimertinib over standard of care in terms of efficacy measured by PFS based on BICR assessment.
Inclusion: Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1; All participants must consent to provide recently obtained FFPE tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met IHC testing and study stratification. c-Met IHC results are required prior to randomization; Participants must have at least one non-irradiated measurable disease per RECIST version 1.1. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans; Any toxicities from prior systemic anti-cancer therapy must have resolved to CTCAE Grade 1 or baseline level (except for alopecia [any grade] or Grade ≤ 2 peripheral neuropathy); Participants should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.
Exclusion: History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest CT scan; History of any malignancy other than disease under study except for a. Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator. b. Successfully treated nonmelanoma skin cancer. c. Localized carcinoma in situ of the cervix. d. Breast Cancer; lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured; Participants has leptomeningeal disease, or subject has spinal cord compression not definitively treated with surgery or radiation; History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.