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)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Ironwood Cancer and Research Centers - Chandler II /ID# 275443 — Chandler, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (53 Sites)
Showing the first 25 of 53 sites.
- Ironwood Cancer and Research Centers - Chandler II /ID# 275443 — Chandler, Arizona
- USC Norris Comprehensive Cancer Center /ID# 275343 — Los Angeles, California
- Usc Norris Oncology/Hematology Treatment Center /ID# 278673 — Newport Beach, California
- University Colorado Cancer Center /ID# 275382 — Aurora, Colorado
- Mid Florida Hematology And Oncology Center /ID# 275278 — Orange City, Florida
- Kaiser Permanente Moanalua Medical Center /ID# 275942 — Honolulu, Hawaii
- The Iowa Clinic /ID# 276020 — West Des Moines, Iowa
- Nho - Revive Research Institute /ID# 276115 — Lincoln, Nebraska
- Renown Regional Medical Center /ID# 276049 — Reno, Nevada
- Texas Oncology - South Austin /ID# 276033 — Austin, Texas
- The University of Texas MD Anderson Cancer Center /ID# 275107 — Houston, Texas
- Texas Oncology - Palestine Cancer Center /ID# 276034 — Palestine, Texas
- Virginia Cancer Specialists - Fairfax /ID# 275071 — Fairfax, Virginia
- University of Washington Medical Center /ID# 275866 — Seattle, Washington
- Liverpool Hospital /ID# 276304 — Liverpool, New South Wales
- The Queen Elizabeth Hospital /ID# 275719 — Woodville, South Australia
- Austin Health /ID# 275505 — Heidelberg, Victoria
- St John Of God Murdoch Hospital /ID# 275700 — Murdoch, Western Australia
- Jessa Ziekenhuis - Campus Virga Jesse /ID# 275585 — Hasselt, Limburg
- Universitair Ziekenhuis Leuven /ID# 275586 — Leuven, Vlaams-Brabant
- AZ-Delta. /ID# 275753 — Roeselare, West-Vlaanderen
- CHU de Liege /ID# 277971 — Liège,
- The Ottawa Hospital - General Campus /ID# 275611 — Ottawa, Ontario
- Princess Margaret Cancer Centre /ID# 274845 — Toronto, Ontario
- Union Hospital Tongji Medical College /ID# 278711 — Wuhan, Hubei
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.