A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Public ClinicalTrials.gov record NCT07155187. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 assess adverse events and change in disease activity of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib compared to standard of care (SOC). 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 as a monotherapy or in combination with osimertinib. 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 490 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 as a monotherapy or in combination with oral osimertinib. 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.
Study identification
- NCT ID
- NCT07155187
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 490 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 9, 2025
- Primary completion
- Aug 31, 2030
- Completion
- Aug 31, 2030
- Last update posted
- Jul 8, 2026
2025 – 2030
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group - Springdale /ID# 277132 | Springdale | Arkansas | 72762 | Recruiting |
| City of Hope National Medical Center /ID# 277005 | Duarte | California | 91010 | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928 | Irvine | California | 92618 | Recruiting |
| Cancer Specialists of North Florida /ID# 277332 | Jacksonville | Florida | 32256 | Recruiting |
| Cancer Care Centers of Brevard- Rockledge /ID# 277853 | Rockledge | Florida | 32955 | Recruiting |
| Moffitt Cancer Center /ID# 276785 | Tampa | Florida | 33612 | Recruiting |
| Parkview Research Center /ID# 277651 | Fort Wayne | Indiana | 46845 | Recruiting |
| HealthPartners Cancer Research Center /ID# 277339 | Saint Louis Park | Minnesota | 55426 | Recruiting |
| Nho - Revive Research Institute /ID# 277569 | Lincoln | Nebraska | 68506 | Recruiting |
| Dartmouth-Hitchcock Medical Center /ID# 277673 | Lebanon | New Hampshire | 03756 | Recruiting |
| Astera Cancer Care /ID# 277570 | East Brunswick | New Jersey | 08816-4096 | Recruiting |
| Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891 | Knoxville | Tennessee | 37909 | Recruiting |
| SCRI Oncology Partners /ID# 276959 | Nashville | Tennessee | 37203 | Recruiting |
| Fred Hutchinson Cancer Center. /ID# 277939 | Seattle | Washington | 98109-4405 | Recruiting |
| Northwest Cancer Specialists - Vancouver /ID# 277855 | Vancouver | Washington | 98684 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 95 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07155187, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 8, 2026 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07155187 live on ClinicalTrials.gov.