Actively Recruiting
A Phase 2/3 Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan with Osimertinib as First-Line Treatment for Advanced EGFR-Mutated Non-Squamous NSCLC
Led by AbbVie · Updated on 2026-06-08
854
Participants Needed
53
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying non-squamous non-small cell lung cancer (NSCLC) with specific mutations in the EGFR gene that cause abnormal cell growth in the lungs. This study aims to evaluate side effects and changes in disease activity when the investigational drug telisotuzumab adizutecan is combined with the approved drug osimertinib (Osi), compared to standard care that includes Osi with chemotherapy. The study is conducted in two stages and includes adults with locally advanced or metastatic NSCLC. In the first stage, participants receive increasing intravenous doses of telisotuzumab adizutecan along with oral osimertinib. Then, participants are randomly assigned to one of several groups receiving different doses of telisotuzumab adizutecan plus Osi or the standard of care involving Osi plus chemotherapy. In the second stage, participants receive the optimal dose of telisotuzumab adizutecan with Osi or standard care. The study treatments will be given over approximately 76 months at medical centers worldwide. Participants will attend regular visits where doctors will monitor treatment effects through medical exams, blood tests, questionnaires, and side effect evaluations. Researchers will measure tumor response, progression-free survival, and adverse events over the study period. Quality of life and lung cancer symptoms will also be assessed using questionnaires. Safety and disease activity will be closely followed throughout the long duration of the trial.
CONDITIONS
Brief 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...
- Adult participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Confirmed diagnosis of locally advanced or metastatic non-squamous NSCLC with classical EGFR mutation (Exon 19 deletion or Exon 21 L858R)
- Availability of recent or archived tumor tissue for c-Met immunohistochemistry testing prior to randomization
- At least one measurable non-irradiated lesion for tumor assessment per RECIST v1.1
- Resolved toxicities from prior cancer therapy to Grade 1 or baseline except alopecia or mild peripheral neuropathy
- Life expectancy of at least 3 months as determined by the investigator
- No prior EGFR tyrosine kinase inhibitor treatment in the advanced setting (except allowed adjuvant treatment if last dose was at least 126 months before study start)
You will not qualify if you...
- History of interstitial lung disease (ILD), pneumonitis requiring systemic steroids, or active ILD/pneumonitis on chest CT scan
- 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 those treated with curative intent and no active disease for 2 years, successfully treated nonmelanoma skin cancer, localized carcinoma in situ of the cervix, or certain cured breast cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 76 months
Participants receive intravenous Telisotuzumab Adizutecan combined with oral Osimertinib or standard of care treatments as first-line therapy for advanced EGFR-mutated non-squamous NSCLC.
Visits occur regularly throughout treatment duration as per protocol
Trial Site Locations
Total: 53 locations
1
Ironwood Cancer and 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
Kaiser Permanente Moanalua Medical Center /ID# 275942
Honolulu, Hawaii, United States, 96819
Actively Recruiting
7
The Iowa Clinic /ID# 276020
West Des Moines, Iowa, United States, 50266
Completed
8
Nho - Revive Research Institute /ID# 276115
Lincoln, Nebraska, United States, 68506
Actively Recruiting
9
Renown Regional Medical Center /ID# 276049
Reno, Nevada, United States, 89502
Actively Recruiting
10
Texas Oncology - South Austin /ID# 276033
Austin, Texas, United States, 78745
Actively Recruiting
11
The University of Texas MD Anderson Cancer Center /ID# 275107
Houston, Texas, United States, 77030
Actively Recruiting
12
Texas Oncology - Palestine Cancer Center /ID# 276034
Palestine, Texas, United States, 75801
Actively Recruiting
13
Virginia Cancer Specialists - Fairfax /ID# 275071
Fairfax, Virginia, United States, 22031
Actively Recruiting
14
University of Washington Medical Center /ID# 275866
Seattle, Washington, United States, 98195
Actively Recruiting
15
Liverpool Hospital /ID# 276304
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
16
The Queen Elizabeth Hospital /ID# 275719
Woodville, South Australia, Australia, 5011
Actively Recruiting
17
Austin Health /ID# 275505
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
18
St John Of God Murdoch Hospital /ID# 275700
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
19
Jessa Ziekenhuis - Campus Virga Jesse /ID# 275585
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
20
Universitair Ziekenhuis Leuven /ID# 275586
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
21
AZ-Delta. /ID# 275753
Roeselare, West-Vlaanderen, Belgium, 8800
Actively Recruiting
22
CHU de Liege /ID# 277971
Liège, Belgium, 4000
Actively Recruiting
23
The Ottawa Hospital - General Campus /ID# 275611
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
24
Princess Margaret Cancer Centre /ID# 274845
Toronto, Ontario, Canada, M5G 2M9
Completed
25
Union Hospital Tongji Medical College /ID# 278711
Wuhan, Hubei, China, 430048
Actively Recruiting
26
Rabin Medical Center. /ID# 274540
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
27
The Chaim Sheba Medical Center /ID# 274541
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
28
Rambam Health Care Campus- Haifa /ID# 274542
Haifa, Israel, 3109601
Actively Recruiting
29
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 274948
Rome, Roma, Italy, 00144
Actively Recruiting
30
Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 275215
Orbassano, Torino, Italy, 10043
Actively Recruiting
31
Yokohama Municipal Citizen's Hospital /ID# 275682
Yokohama, Kanagawa, Japan, 221-0855
Actively Recruiting
32
Niigata University Medical and Dental Hospital /ID# 275685
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
33
Osaka Medical And Pharmaceutical University Hospital /ID# 275684
Takatsuki, Osaka, Japan, 569-8686
Actively Recruiting
34
Shizuoka Cancer Center /ID# 278082
Sunto-gun, Shizuoka, Japan, 411-8777
Actively Recruiting
35
Juntendo University Hospital /ID# 276424
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
36
National Cancer Center Hospital /ID# 275678
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
37
Unidade Local de Saude de Braga, EPE /ID# 275394
Braga, Portugal, 4710-243
Actively Recruiting
38
Unidade Local de Saude de Santo Antonio /ID# 275387
Porto, Portugal, 4099-003
Actively Recruiting
39
Hospital Cuf Porto /ID# 275395
Porto, Portugal, 4100-180
Actively Recruiting
40
National Cancer Centre Singapore /ID# 275986
Singapore, Central Singapore, Singapore, 169611
Actively Recruiting
41
National University Hospital /ID# 275988
Singapore, Singapore, 119074
Actively Recruiting
42
Inje University Haeundae Paik Hospital /ID# 275388
Busan, Busan Gwang Yeogsi, South Korea, 48108
Actively Recruiting
43
Chungbuk National University Hospital /ID# 275768
Cheongju-si, North Chungcheong, South Korea, 28644
Actively Recruiting
44
Yonsei University Health System Severance Hospital /ID# 275384
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
45
Asan Medical Center /ID# 275600
Seoul, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
46
Samsung Medical Center /ID# 278083
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
47
Hospital Clinic de Barcelona /ID# 275476
Barcelona, Spain, 08036
Actively Recruiting
48
Hospital General Universitario Gregorio Maranon /ID# 275475
Madrid, Spain, 28007
Actively Recruiting
49
Hospital Universitario 12 de Octubre /ID# 277698
Madrid, Spain, 28041
Actively Recruiting
50
Instituto Valenciano de Oncología /ID# 275471
Valencia, Spain, 46009
Actively Recruiting
51
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 275293
Kaohsiung City, Taiwan, 807
Actively Recruiting
52
National Taiwan University Cancer Center (Ntucc) /ID# 275291
Taipei, Taiwan, 106
Actively Recruiting
53
Taipei Veterans General Hospital /ID# 275292
Taipei, Taiwan, 112
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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