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
Public ClinicalTrials.gov record NCT07005102. 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 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
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 "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy). 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 doses of telisotuzumab adizutecan from from the dose escalation phase with Osi, or standard of care (Osi plus chemotherapy). In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 854 adult participants with 1L estimated glomerular filtration rate (EGFR) mut (mutated) not sufficient quantity (NSq) NSCLC 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. participants will receive 1 of 3 doses of telisotuzumab adizutecan with Osi, or standard of care (Osi plus chemotherapy). In stage 2 participants will receive 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.
Study identification
- NCT ID
- NCT07005102
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 854 participants
Conditions and interventions
Conditions
Interventions
- Standard of Care Drug
- Telisotuzumab Adizutecan Drug
- Osimertinib (Osi) Drug
- Cisplatin Drug
- Carboplatin Drug
- Pemetrexed Drug
Drug
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
- Aug 2, 2025
- Primary completion
- Nov 30, 2031
- Completion
- Oct 31, 2036
- Last update posted
- Jun 7, 2026
2025 – 2036
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer and Research Centers - Chandler II /ID# 275443 | Chandler | Arizona | 85224 | Recruiting |
| USC Norris Comprehensive Cancer Center /ID# 275343 | Los Angeles | California | 90033 | Recruiting |
| Usc Norris Oncology/Hematology Treatment Center /ID# 278673 | Newport Beach | California | 92663 | Recruiting |
| University Colorado Cancer Center /ID# 275382 | Aurora | Colorado | 80045-2517 | Recruiting |
| Mid Florida Hematology And Oncology Center /ID# 275278 | Orange City | Florida | 32763 | Recruiting |
| Kaiser Permanente Moanalua Medical Center /ID# 275942 | Honolulu | Hawaii | 96819 | Recruiting |
| The Iowa Clinic /ID# 276020 | West Des Moines | Iowa | 50266 | Completed |
| Nho - Revive Research Institute /ID# 276115 | Lincoln | Nebraska | 68506 | Recruiting |
| Renown Regional Medical Center /ID# 276049 | Reno | Nevada | 89502 | Recruiting |
| Texas Oncology - South Austin /ID# 276033 | Austin | Texas | 78745 | Recruiting |
| The University of Texas MD Anderson Cancer Center /ID# 275107 | Houston | Texas | 77030 | Recruiting |
| Texas Oncology - Palestine Cancer Center /ID# 276034 | Palestine | Texas | 75801 | Recruiting |
| Virginia Cancer Specialists - Fairfax /ID# 275071 | Fairfax | Virginia | 22031 | Recruiting |
| University of Washington Medical Center /ID# 275866 | Seattle | Washington | 98195 | 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 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07005102, 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 Jun 7, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07005102 live on ClinicalTrials.gov.