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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
NCT07005102 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Telisotuzumab Adizutecan
- DRUG Standard of Care
- DRUG Osimertinib (Osi)
Study Locations (20)
Texas
- Texas Oncology - South Austin /ID# 276033 — Austin
- The University of Texas MD Anderson Cancer Center /ID# 275107 — Houston
- Texas Oncology - Palestine Cancer Center /ID# 276034 — Palestine
California
- USC Norris Comprehensive Cancer Center /ID# 275343 — Los Angeles
- Usc Norris Oncology/Hematology Treatment Center /ID# 278673 — Newport Beach
Colorado
- University Colorado Cancer Center /ID# 275382 — Aurora
Florida
- Mid Florida Hematology And Oncology Center /ID# 275278 — Orange City
Iowa
- The Iowa Clinic /ID# 276020 — West Des Moines
Nebraska
- Nho - Revive Research Institute /ID# 276115 — Lincoln
Nevada
- Renown Regional Medical Center /ID# 276049 — Reno
Virginia
- Virginia Cancer Specialists - Fairfax /ID# 275071 — Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 854 participants |
| Start Date | 2025-08-03 |
| Est. Completion | 2036-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07005102
The ClinicalTrials.gov registry entry for NCT07005102 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 854 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-Squamous Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07005102 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Texas, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07005102 about?
NCT07005102 is a clinical study titled "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". 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)...
What is the current status of trial NCT07005102?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 854 participants. The study started on 2025-08-03. Estimated completion is 2036-11.
What conditions does trial NCT07005102 study?
This clinical trial studies the following conditions: Non-Squamous Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07005102?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Telisotuzumab Adizutecan (DRUG), Standard of Care (DRUG), Osimertinib (Osi) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07005102?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07005102 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Iowa, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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