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
Start Date
8/3/2025
Completion Date
11/1/2036
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Standard of Care
Telisotuzumab Adizutecan
Osimertinib (Osi)
Cisplatin
Carboplatin
Pemetrexed
Conditions
Locations
Ironwood Cancer and Research Centers - Chandler II /ID# 275443
Chandler, Arizona 85224
United States
USC Norris Comprehensive Cancer Center /ID# 275343
Los Angeles, California 90033
United States
Usc Norris Oncology/Hematology Treatment Center /ID# 278673
Newport Beach, California 92663
United States
University Colorado Cancer Center /ID# 275382
Aurora, Colorado 80045-2517
United States
Mid Florida Hematology And Oncology Center /ID# 275278
Orange City, Florida 32763
United States
Kaiser Permanente Moanalua Medical Center /ID# 275942
Honolulu, Hawaii 96819
United States
The Iowa Clinic /ID# 276020
West Des Moines, Iowa 50266
United States
Nho - Revive Research Institute /ID# 276115
Lincoln, Nebraska 68506
United States
Renown Regional Medical Center /ID# 276049
Reno, Nevada 89502
United States
Texas Oncology - South Austin /ID# 276033
Austin, Texas 78745
United States
The University of Texas MD Anderson Cancer Center /ID# 275107
Houston, Texas 77030
United States
Texas Oncology - Palestine Cancer Center /ID# 276034
Palestine, Texas 75801
United States
Virginia Cancer Specialists - Fairfax /ID# 275071
Fairfax, Virginia 22031
United States
University of Washington Medical Center /ID# 275866
Seattle, Washington 98195
United States
Liverpool Hospital /ID# 276304
Liverpool, New South Wales 2170
Australia
The Queen Elizabeth Hospital /ID# 275719
Woodville, South Australia 5011
Australia
Austin Health /ID# 275505
Heidelberg, Victoria 3084
Australia
St John Of God Murdoch Hospital /ID# 275700
Murdoch, Western Australia 6150
Australia
Jessa Ziekenhuis - Campus Virga Jesse /ID# 275585
Hasselt, Limburg 3500
Belgium
Universitair Ziekenhuis Leuven /ID# 275586
Leuven, Vlaams-Brabant 3000
Belgium
AZ-Delta. /ID# 275753
Roeselare, West-Vlaanderen 8800
Belgium
CHU de Liege /ID# 277971
Liège, 4000
Belgium
The Ottawa Hospital - General Campus /ID# 275611
Ottawa, Ontario K1H 8L6
Canada
Princess Margaret Cancer Centre /ID# 274845
Toronto, Ontario M5G 2M9
Canada
Union Hospital Tongji Medical College /ID# 278711
Wuhan, Hubei 430048
China
Rabin Medical Center. /ID# 274540
Petah Tikva, Central District 4941492
Israel
The Chaim Sheba Medical Center /ID# 274541
Ramat Gan, Tel Aviv 5265601
Israel
Rambam Health Care Campus- Haifa /ID# 274542
Haifa, 3109601
Israel
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 274948
Rome, Roma 00144
Italy
Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 275215
Orbassano, Torino 10043
Italy
Yokohama Municipal Citizen's Hospital /ID# 275682
Yokohama, Kanagawa 221-0855
Japan
Niigata University Medical and Dental Hospital /ID# 275685
Niigata, Niigata 951-8520
Japan
Osaka Medical And Pharmaceutical University Hospital /ID# 275684
Takatsuki, Osaka 569-8686
Japan
Shizuoka Cancer Center /ID# 278082
Sunto-gun, Shizuoka 411-8777
Japan
Juntendo University Hospital /ID# 276424
Bunkyo-ku, Tokyo 113-8431
Japan
National Cancer Center Hospital /ID# 275678
Chuo-Ku, Tokyo 104-0045
Japan
Unidade Local de Saude de Braga, EPE /ID# 275394
Braga, 4710-243
Portugal
Unidade Local de Saude de Santo Antonio /ID# 275387
Porto, 4099-003
Portugal
Hospital Cuf Porto /ID# 275395
Porto, 4100-180
Portugal
National Cancer Centre Singapore /ID# 275986
Singapore, Central Singapore 169611
Singapore
National University Hospital /ID# 275988
Singapore, 119074
Singapore
Inje University Haeundae Paik Hospital /ID# 275388
Busan, Busan Gwang Yeogsi 48108
South Korea
Chungbuk National University Hospital /ID# 275768
Cheongju-si, North Chungcheong 28644
South Korea
Yonsei University Health System Severance Hospital /ID# 275384
Seoul, Seoul Teugbyeolsi 03722
South Korea
Asan Medical Center /ID# 275600
Seoul, Seoul Teugbyeolsi 05505
South Korea
Samsung Medical Center /ID# 278083
Seoul, Seoul Teugbyeolsi 06351
South Korea
Hospital Clinic de Barcelona /ID# 275476
Barcelona, 08036
Spain
Hospital General Universitario Gregorio Maranon /ID# 275475
Madrid, 28007
Spain
Hospital Universitario 12 de Octubre /ID# 277698
Madrid, 28041
Spain
Instituto Valenciano de Oncología /ID# 275471
Valencia, 46009
Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 275293
Kaohsiung City, 807
Taiwan
National Taiwan University Cancer Center (Ntucc) /ID# 275291
Taipei, 106
Taiwan
Taipei Veterans General Hospital /ID# 275292
Taipei, 112
Taiwan