A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
NCT ID: NCT07155187
Last Updated: 2025-12-26
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
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RECRUITING
PHASE2/PHASE3
430 participants
INTERVENTIONAL
2025-12-10
2030-09-30
Brief Summary
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Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 430 adult participants with NSCLC will be enrolled in the study in 200 sites around the world.
In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 2: Telisotuzumab Adizutecan Dose A
Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Phase 2: Telisotuzumab Adizutecan Dose B
Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose
Participants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Phase 3: Stand of Care (SOC)
Participants will receive investigator's choice of SOC, as part of the approximately 69 month study duration.
Standard of Care
Standard of Care
Interventions
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Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Standard of Care
Standard of Care
Eligibility Criteria
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Inclusion Criteria
* Provide archived or recently obtained tumor tissue during Screening.
* Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry.
* 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.
* Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
* Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded.
* If the prior third-generation EGFR TKI was administered in the adjuvant setting, progression must have occurred while on treatment.
Exclusion Criteria
* Received more than 1 line of systemic therapy in the locally advanced or metastatic setting.
* Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Highlands Oncology Group - Springdale /ID# 277132
Springdale, Arkansas, United States
Nho - Revive Research Institute /ID# 277569
Lincoln, Nebraska, United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
Knoxville, Tennessee, United States
Northwest Cancer Specialists - Vancouver /ID# 277855
Vancouver, Washington, United States
Mater Hospital Brisbane /ID# 276985
South Brisbane, Queensland, Australia
Icon Cancer Centre Hobart /ID# 277549
Hobart, Tasmania, Australia
St Vincent's Hospital Melbourne /ID# 277002
Fitzroy, Victoria, Australia
Sunshine Hospital /ID# 276894
St Albans, Victoria, Australia
Meir Medical Center /ID# 277289
Kfar Saba, Central District, Israel
Rambam Health Care Campus /ID# 276746
Haifa, , Israel
Kitasato University Hospital /ID# 277241
Sagamihara-shi, Kanagawa, Japan
National Cancer Center Hospital /ID# 277093
Chuo-Ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 277238
Wakayama, Wakayama, Japan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2025-521124-29
Identifier Type: OTHER
Identifier Source: secondary_id
M25-713
Identifier Type: -
Identifier Source: org_study_id