2024-518586-10-00RecruitingPhase 2/3
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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- 18 Sept 2025
- Lead sponsor
- AbbVie Deutschland GmbH & Co. KG
- Diseases
- Lung cancer
- EU CT number
- 2024-518586-10-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 50
- 17 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-squamous non-small cell lung cancer that has an EGFR mutation, is advanced or has spread, and cannot be removed by surgery. It tests telisotuzumab adizutecan with osimertinib as first treatment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Locally advanced and unresectable, or metastatic EGFR-mutated non-squamous non-small cell lung cancer, with at least one measurable tumour that has not been irradiated
- Earlier treatment
- Side effects from earlier cancer treatment must have settled to Grade 1 or the starting level, apart from hair loss or nerve damage up to Grade 2
- Biomarker or test result
- Tumour tissue must be given for c-Met IHC testing before randomization
Main reasons for not taking part
- History of interstitial lung disease or pneumonitis treated with steroids
- History of pulmonary fibrosis or organizing pneumonia
- Another cancer, apart from a few limited exceptions
- Leptomeningeal disease
- Spinal cord compression not definitively treated with surgery or radiation
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| JESSA Ziekenhuis | Hasselt | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège | Liège | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta | Roeselare | Belgium | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Institut Catala D'oncologia | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Fundación Instituto Valenciano de Oncología | Valencia | Spain | Recruiting |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano | Italy | Recruiting |
| Hospital Santa Maria Della Misericordia | Perugia | Italy | Recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri | Rome | Italy | Recruiting |
| Università Campus Bio-Medico di Roma | Rome | Italy | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao | Braga | Portugal | Recruiting |
| Hospital CUF Porto S.A. | Porto | Portugal | Recruiting |
| Unidade Local De Saude De Santo Antonio E.P.E. | Porto | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.