Actively Recruiting
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
Led by AbbVie · Updated on 2026-05-13
854
Participants Needed
48
Research Sites
586 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening and before treatment start
- Consent to provide recent or archived tumor tissue for c-Met testing before randomization
- At least one measurable, non-irradiated lesion per RECIST 1.1 criteria
- Resolved toxicities from prior cancer therapies to Grade 1 or baseline except alopecia or Grade ≤ 2 peripheral neuropathy
- No major life-threatening conditions and expected survival of at least 3 months
- No prior EGFR tyrosine kinase inhibitor in advanced/metastatic setting except allowed prior adjuvant treatment if ≥ 126 months since last dose
- Confirmed metastatic or locally advanced non-squamous NSCLC with classical EGFR mutation (Exon 19 deletion or Exon 21 L858R) documented by approved testing
You will not qualify if you...
- History or evidence of interstitial lung disease or pneumonitis requiring systemic steroids
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
- Presence of leptomeningeal disease or untreated spinal cord compression
- History of other malignancies except treated curative malignancies with no active disease for 2 years, successfully treated nonmelanoma skin cancer, localized carcinoma in situ of the cervix, or fully cured breast carcinoma in situ
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 48 locations
1
Ironwood Cancer & Research Centers - Chandler II /ID# 275443
Chandler, Arizona, United States, 85224
Actively Recruiting
2
USC Norris Comprehensive Cancer Center /ID# 275343
Los Angeles, California, United States, 90033
Actively Recruiting
3
Usc Norris Oncology/Hematology Treatment Center /ID# 278673
Newport Beach, California, United States, 92663
Actively Recruiting
4
University Colorado Cancer Center /ID# 275382
Aurora, Colorado, United States, 80045-2517
Actively Recruiting
5
Mid Florida Hematology And Oncology Center /ID# 275278
Orange City, Florida, United States, 32763
Actively Recruiting
6
The Iowa Clinic /ID# 276020
West Des Moines, Iowa, United States, 50266
Completed
7
Nho - Revive Research Institute /ID# 276115
Lincoln, Nebraska, United States, 68506
Actively Recruiting
8
Renown Regional Medical Center /ID# 276049
Reno, Nevada, United States, 89502
Actively Recruiting
9
Texas Oncology - South Austin /ID# 276033
Austin, Texas, United States, 78745
Actively Recruiting
10
The University of Texas MD Anderson Cancer Center /ID# 275107
Houston, Texas, United States, 77030
Actively Recruiting
11
Texas Oncology - Palestine Cancer Center /ID# 276034
Palestine, Texas, United States, 75801
Actively Recruiting
12
Virginia Cancer Specialists - Fairfax /ID# 275071
Fairfax, Virginia, United States, 22031
Actively Recruiting
13
University of Washington Medical Center /ID# 275866
Seattle, Washington, United States, 98195
Actively Recruiting
14
Liverpool Hospital /ID# 276304
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
15
The Queen Elizabeth Hospital /ID# 275719
Woodville, South Australia, Australia, 5011
Actively Recruiting
16
Austin Health /ID# 275505
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
17
St John Of God Murdoch Hospital /ID# 275700
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
18
Jessa Ziekenhuis - Campus Virga Jesse /ID# 275585
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
19
Universitair Ziekenhuis Leuven /ID# 275586
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
20
AZ-Delta. /ID# 275753
Roeselare, West-Vlaanderen, Belgium, 8800
Actively Recruiting
21
CHU de Liege /ID# 277971
Liège, Belgium, 4000
Actively Recruiting
22
The Ottawa Hospital - General Campus /ID# 275611
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
23
The Chaim Sheba Medical Center /ID# 274541
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
24
Rambam Health Care Campus- Haifa /ID# 274542
Haifa, Israel, 3525408
Actively Recruiting
25
Rabin Medical Center. /ID# 274540
Petah Tikva, Israel, 4941492
Actively Recruiting
26
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 274948
Rome, Roma, Italy, 00144
Actively Recruiting
27
Yokohama Municipal Citizen's Hospital /ID# 275682
Yokohama, Kanagawa, Japan, 221-0855
Actively Recruiting
28
Niigata University Medical & Dental Hospital /ID# 275685
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
29
Osaka Medical And Pharmaceutical University Hospital /ID# 275684
Takatsuki, Osaka, Japan, 569-8686
Actively Recruiting
30
Juntendo University Hospital /ID# 276424
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
31
National Cancer Center Hospital /ID# 275678
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
32
Unidade Local de Saude de Braga, EPE /ID# 275394
Braga, Portugal, 4710-243
Actively Recruiting
33
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 275387
Porto, Portugal, 4099-003
Actively Recruiting
34
Hospital Cuf Porto /ID# 275395
Porto, Portugal, 4100-180
Actively Recruiting
35
National Cancer Centre Singapore /ID# 275986
Singapore, Central Singapore, Singapore, 169611
Actively Recruiting
36
National University Hospital /ID# 275988
Singapore, Singapore, 119074
Actively Recruiting
37
Inje University Haeundae Paik Hospital /ID# 275388
Busan, Busan Gwang Yeogsi, South Korea, 48108
Actively Recruiting
38
Chungbuk National University Hospital /ID# 275768
Cheongju-si, North Chungcheong, South Korea, 28644
Actively Recruiting
39
Yonsei University Health System Severance Hospital /ID# 275384
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
40
Asan Medical Center /ID# 275600
Seoul, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
41
Samsung Medical Center /ID# 278083
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
42
Hospital Clinic de Barcelona /ID# 275476
Barcelona, Spain, 08036
Actively Recruiting
43
Hospital General Universitario Gregorio Maranon /ID# 275475
Madrid, Spain, 28007
Actively Recruiting
44
Hospital Universitario 12 de Octubre /ID# 277698
Madrid, Spain, 28041
Actively Recruiting
45
Instituto Valenciano de Oncología /ID# 275471
Valencia, Spain, 46009
Actively Recruiting
46
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 275293
Kaohsiung City, Taiwan, 807
Actively Recruiting
47
National Taiwan University Cancer Center (Ntucc) /ID# 275291
Taipei, Taiwan, 106
Actively Recruiting
48
Taipei Veterans General Hospital /ID# 275292
Taipei, Taiwan, 112
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here