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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dobry stan zdrowia ogólnego (możliwość wykonywania normalnych czynności)
- •Potwierdzony histologicznie lub cytologicznie zaawansowany rak płuc bez komórek płaskych z mutacją EGFR
- •Dostępny materiał z biopsji guza do badania laboratoryjnego
- •Co najmniej jeden mierzalny guz, który nie był wcześniej promieniowany
- •Skutki uboczne poprzedniego leczenia muszą ustąpić
- •Oczekiwana długość życia co najmniej 3 miesiące
- •Nigdy wcześniej nie był leczony inhibitorami EGFR w zaawansowanym raku płuc
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 5, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (65)
Ironwood Cancer and Research Centers - Chandler /ID# 275443
Chandler, United States
City of Hope National Medical Center /ID# 282241
Duarte, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 284734
Irvine, United States
USC Norris Comprehensive Cancer Center /ID# 275343
Los Angeles, United States
Usc Norris Oncology/Hematology Treatment Center /ID# 278673
Newport Beach, United States
UCLA - Santa Monica /ID# 276816
Santa Monica, United States
City Of Hope - Upland /ID# 284650
Upland, United States
University Colorado Cancer Center /ID# 275382
Aurora, United States
Mid Florida Hematology And Oncology Center /ID# 275278
Orange City, United States
Kaiser Permanente Moanalua Medical Center /ID# 275942
Honolulu, United States
The Iowa Clinic /ID# 276020
West Des Moines, United States
Nho - Revive Research Institute /ID# 276115
Lincoln, United States
Renown Regional Medical Center /ID# 276049
Reno, United States
Texas Oncology - South Austin /ID# 276033
Austin, United States
The University of Texas MD Anderson Cancer Center /ID# 275107
Houston, United States
Texas Oncology - Palestine Cancer Center /ID# 276034
Palestine, United States
Virginia Cancer Specialists - Fairfax /ID# 275071
Fairfax, United States
University of Washington Medical Center /ID# 275866
Seattle, United States
Liverpool Hospital /ID# 276304
Liverpool, Australia
The Queen Elizabeth Hospital /ID# 275719
Woodville South, Australia
Austin Health /ID# 275505
Heidelberg, Australia
St John of God Murdoch Hospital /ID# 275700
Murdoch, Australia
Jessa Ziekenhuis - Campus Virga Jesse /ID# 275585
Hasselt, Belgium
Universitair Ziekenhuis Leuven /ID# 275586
Leuven, Belgium
AZ-Delta. /ID# 275753
Roeselare, Belgium
CHU de Liege /ID# 277971
Liège, Belgium
The Ottawa Hospital - General Campus /ID# 275611
Ottawa, Canada
Princess Margaret Cancer Centre /ID# 274845
Toronto, Canada
Cancer Hospital - Chinese Academy of Medical Sciences /ID# 275631
Beijing, China
Fujian Province Cancer Hospital /ID# 274913
Fuzhou, China
The First Affiliated Hospital Of Guangzhou Medical University /ID# 274914
Guangzhou, China
Union Hospital Tongji Medical College /ID# 278711
Wuhan, China
The First affiliated hospital of Nanchang University /ID# 275257
Nanchang, China
Shanghai Chest Hospital /ID# 275273
Shanghai, China
West China Hospital of Sichuan University /ID# 274946
Chengdu, China
Rabin Medical Center. /ID# 274540
Petah Tikva, Israel
The Chaim Sheba Medical Center /ID# 274541
Ramat Gan, Israel
Rambam Health Care Campus- Haifa /ID# 274542
Haifa, Israel
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 274948
Rome, Italy
Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 275215
Orbassano, Italy
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 277808
Perugia, Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 280103
Roma, Italy
Yokohama Municipal Citizen's Hospital /ID# 275682
Yokohama, Japan
Niigata University Medical and Dental Hospital /ID# 275685
Niigata, Japan
Osaka Medical And Pharmaceutical University Hospital /ID# 275684
Takatsuki, Japan
Shizuoka Cancer Center /ID# 278082
Sunto-gun, Japan
Juntendo University Hospital /ID# 276424
Bunkyo-ku, Japan
National Cancer Center Hospital /ID# 275678
Chuo-Ku, Japan
Unidade Local de Saude de Braga, EPE /ID# 275394
Braga, Portugal
Unidade Local de Saude de Santo Antonio /ID# 275387
Porto, Portugal
Hospital Cuf Porto /ID# 275395
Porto, Portugal
National Cancer Centre Singapore /ID# 275986
Singapore, Singapore
National University Hospital /ID# 275988
Singapore, Singapore
Inje University Haeundae Paik Hospital /ID# 275388
Busan, South Korea
Chungbuk National University Hospital /ID# 275768
Cheongju-si, South Korea
Yonsei University Health System Severance Hospital /ID# 275384
Seoul, South Korea
Asan Medical Center /ID# 275600
Seoul, South Korea
Samsung Medical Center /ID# 278083
Seoul, South Korea
Hospital Clinic de Barcelona /ID# 275476
Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 275475
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 277698
Madrid, Spain
Instituto Valenciano de Oncologia /ID# 275471
Valencia, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 275293
Kaohsiung City, Taiwan
National Taiwan University Cancer Center (Ntucc) /ID# 275291
Taipei, Taiwan
Taipei Veterans General Hospital /ID# 275292
Taipei, Taiwan
Trial contact
ABBVIE CALL CENTER
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/6/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.