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
NCT ID: NCT07005102
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
694 participants
INTERVENTIONAL
2025-08-03
2031-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 optimized doses of telisotuzumab adizutecan from the dose escalation phase with Osi, or Osi alone. In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 694 adult participants with mCRC will be enrolled in the study in 200 sites worldwide.
In Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. During dose optimization participants will receive OSi alone or with 1 of 3 optimized doses of telisotuzumab adizutecan. In stage 2 participnats will recieve the optimal dose of IV telisotuzumab adizutecanin with oral Osi tablet, or SOC. The study will run for a duration of approximately 76 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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stage 1: Escalation Telisotuzumab Adizutecan with Osimertinib
Participants will receive increasing doses of telisotuzumab adizutecan with osimertinib (Osi), as part of the approximately 76 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Osimertinib (Osi)
Oral Tablet
Stage 1: Expansion Telisotuzumab Adizutecan Dose A with Osi
Participants will receive telisotuzumab adizutecan dose A with Osi, as part of the approximately 76 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Osimertinib (Osi)
Oral Tablet
Stage 1: Expansion Telisotuzumab Adizutecan Dose B with Osi
Participants will receive telisotuzumab adizutecan dose B with Osi, as part of the approximately 76 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Osimertinib (Osi)
Oral Tablet
Stage 1: Expansion Telisotuzumab Adizutecan Dose C with Osi
Participants will receive telisotuzumab adizutecan dose C with Osi, as part of the approximately 76 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Osimertinib (Osi)
Oral Tablet
Stage 1: Expansion Osi
Participants will receive Osi, as part of the approximately 76 month study duration.
Osimertinib (Osi)
Oral Tablet
Stage 2: Standared of Care (SOC) Osi
Participants will receive Osi, as part of the approximately 76 month study duration.
Standard of Care
Standard of Care
Stage 2: Telisotuzumab Adizutecan Optimized with Osi
Participants will receive the optimized dose of telisotuzumab adizutecan with Osi, as part of the approximately 76 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Osimertinib (Osi)
Oral Tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard of Care
Standard of Care
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Osimertinib (Osi)
Oral Tablet
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must consent to provide recently obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met immunohistochemistry (IHC) testing and study stratification. c-Met IHC results are required prior to randomization.
* Must have at least one non-irradiated measurable disease per Response Evaluation Criteria in Solid Tumors (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 common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level (except for alopecia \[any grade\] or Grade \<= 2 peripheral neuropathy).
* Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.
Exclusion Criteria
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
* Participants has leptomeningeal disease, or subject has spinal cord compression not definitively treated with surgery or radiation.
* History of any malignancy except for 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, successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
USC Norris Comprehensive Cancer Center /ID# 275343
Los Angeles, California, United States
Usc Norris Oncology/Hematology Treatment Center /ID# 278673
Newport Beach, California, United States
Mid Florida Hematology And Oncology Center /ID# 275278
Orange City, Florida, United States
The Iowa Clinic /ID# 276020
West Des Moines, Iowa, United States
Nho - Revive Research Institute /ID# 276115
Lincoln, Nebraska, United States
Renown Regional Medical Center /ID# 276049
Reno, Nevada, United States
Texas Oncology - South Austin /ID# 276033
Austin, Texas, United States
The University of Texas MD Anderson Cancer Center /ID# 275107
Houston, Texas, United States
Texas Oncology - Palestine Cancer Center /ID# 276034
Palestine, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 275071
Fairfax, Virginia, United States
The Queen Elizabeth Hospital /ID# 275719
Woodville, South Australia, Australia
Austin Health /ID# 275505
Heidelberg, Victoria, Australia
St John Of God Murdoch Hospital /ID# 275700
Murdoch, Western Australia, Australia
Jessa Ziekenhuis - Campus Virga Jesse /ID# 275585
Hasselt, Limburg, Belgium
Universitair Ziekenhuis Leuven /ID# 275586
Leuven, Vlaams-Brabant, Belgium
AZ-Delta /ID# 275753
Roeselare, West-Vlaanderen, Belgium
The Chaim Sheba Medical Center /ID# 274541
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus /ID# 274542
Haifa, , Israel
Rabin Medical Center /ID# 274540
Petah Tikva, , Israel
Yokohama Municipal Citizen's Hospital /ID# 275682
Yokohama, Kanagawa, Japan
Niigata University Medical & Dental Hospital /ID# 275685
Niigata, Niigata, Japan
Osaka Medical And Pharmaceutical University Hospital /ID# 275684
Takatsuki, Osaka, Japan
Juntendo University Hospital /ID# 276424
Bunkyo-ku, Tokyo, Japan
Unidade Local de Saude de Braga, EPE /ID# 275394
Braga, , Portugal
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 275387
Porto, , Portugal
Hospital Cuf Porto /ID# 275395
Porto, , Portugal
National University Hospital /ID# 275988
Singapore, , Singapore
Inje University Haeundae Paik Hospital /ID# 275388
Busan, Busan Gwang Yeogsi, South Korea
Chungbuk National University Hospital /ID# 275768
Cheongju-si, North Chungcheong, South Korea
Asan Medical Center /ID# 275600
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Clinic de Barcelona /ID# 275476
Barcelona, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 275293
Kaohsiung City, , Taiwan
Taipei Veterans General Hospital /ID# 275292
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-518586-10
Identifier Type: OTHER
Identifier Source: secondary_id
M25-287
Identifier Type: -
Identifier Source: org_study_id