Actively Recruiting
A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Led by AbbVie · Updated on 2026-03-11
430
Participants Needed
53
Research Sites
246 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 of telisotuzumab adizutecan compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 430 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 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 and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR Exon 19 deletion or Exon 21 L858R mutation
- Provide archived or recent tumor tissue during screening
- Received one prior third-generation EGFR TKI therapy and had documented disease progression after treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- At least one measurable lesion per RECIST version 1.1 that has not been previously irradiated
- Clinically asymptomatic or stable central nervous system metastasis after treatment
- Progression must have occurred during treatment if prior EGFR TKI was given as adjuvant therapy
You will not qualify if you...
- Tumors with adenosquamous, squamous histology, or sarcomatoid features
- Received more than one line of systemic therapy in the locally advanced or metastatic setting
- Presence of clinically significant medical conditions or other reasons interfering with participation
- Current, past, or suspected interstitial lung disease or pneumonitis requiring steroids
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 locations
1
Highlands Oncology Group - Springdale /ID# 277132
Springdale, Arkansas, United States, 72762
Actively Recruiting
2
Cancer Care Centers of Brevard- Rockledge /ID# 277853
Rockledge, Florida, United States, 32955
Actively Recruiting
3
HealthPartners Cancer Research Center /ID# 277339
Saint Louis Park, Minnesota, United States, 55426
Actively Recruiting
4
Nho - Revive Research Institute /ID# 277569
Lincoln, Nebraska, United States, 68506
Actively Recruiting
5
Astera Cancer Care /ID# 277570
East Brunswick, New Jersey, United States, 08816-4096
Actively Recruiting
6
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
Knoxville, Tennessee, United States, 37909
Actively Recruiting
7
SCRI Oncology Partners /ID# 276959
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
Northwest Cancer Specialists - Vancouver /ID# 277855
Vancouver, Washington, United States, 98684
Actively Recruiting
9
Canberra Hospital /ID# 277166
Garran, Australian Capital Territory, Australia, 2605
Actively Recruiting
10
St George Hospital /ID# 277168
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
11
Mater Hospital Brisbane /ID# 276985
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
12
Icon Cancer Centre Hobart /ID# 277549
Hobart, Tasmania, Australia, 7000
Actively Recruiting
13
St Vincent's Hospital Melbourne /ID# 277002
Fitzroy, Victoria, Australia, 03065
Actively Recruiting
14
Sunshine Hospital /ID# 276894
St Albans, Victoria, Australia, 3021
Actively Recruiting
15
One Clinical Research - Nedlands /ID# 277598
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
16
Klinik Floridsdorf /ID# 276679
Vienna, State of Vienna, Austria, 1210
Actively Recruiting
17
Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
18
Universitair Ziekenhuis Leuven /ID# 276874
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
19
Guangdong Provincial People'S Hospital /ID# 277631
Guangzhou, Guangdong, China, 510080
Actively Recruiting
20
Universitaetsklinikum Heidelberg /ID# 277275
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
21
Universitaetsklinikum Wuerzburg /ID# 277213
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
22
Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873
Marburg, Hesse, Germany, 35043
Actively Recruiting
23
Universitaetsklinikum Koeln /ID# 276862
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
24
Universitätsklinikum Jena /ID# 277281
Jena, Thuringia, Germany, 07747
Actively Recruiting
25
Meir Medical Center /ID# 277289
Kfar Saba, Central District, Israel, 4428164
Actively Recruiting
26
Rabin Medical Center /ID# 276748
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
27
Yitzhak Shamir Medical Center /ID# 276750
Ẕerifin, Central District, Israel, 7030000
Actively Recruiting
28
The Chaim Sheba Medical Center /ID# 276745
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
29
Rambam Health Care Campus- Haifa /ID# 276746
Haifa, Israel, 3525408
Actively Recruiting
30
Ospedale Isola Tiberina - Gemelli Isola /ID# 277117
Rome, Roma, Italy, 00186
Actively Recruiting
31
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119
Candiolo, Torino, Italy, 10060
Actively Recruiting
32
Hokkaido University Hospital /ID# 277240
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
33
Kitasato University Hospital /ID# 277241
Sagamihara-shi, Kanagawa, Japan, 252-0375
Actively Recruiting
34
National Cancer Center Hospital /ID# 277093
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
35
Wakayama Medical University Hospital /ID# 277238
Wakayama, Wakayama, Japan, 641-8510
Actively Recruiting
36
Unidade Local de Saude do Alto Ave, EPE /ID# 277249
Guimarães, Braga District, Portugal, 4835-044
Actively Recruiting
37
Unidade Local de Saude de Loures-Odivelas, EPE /ID# 277223
Loures, Lisbon District, Portugal, 2674-514
Actively Recruiting
38
Unidade Local de Saude de Matosinhos, EPE /ID# 277228
Senhora da Hora, Porto District, Portugal, 4464-513
Actively Recruiting
39
Unidade Local de Saude de Braga, EPE /ID# 277217
Braga, Portugal, 4710-243
Actively Recruiting
40
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 277216
Porto, Portugal, 4099-003
Actively Recruiting
41
National Cancer Center /ID# 277353
Goyang-si, Gyeonggido, South Korea, 10408
Actively Recruiting
42
Chungbuk National University Hospital /ID# 277372
Cheongju-si, North Chungcheong, South Korea, 28644
Actively Recruiting
43
Seoul National University Hospital /ID# 277373
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
44
Asan Medical Center /ID# 277371
Seoul, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
45
Samsung Medical Center /ID# 277600
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
46
Hospital Universitario Virgen de la Victoria /ID# 277159
Málaga, Spain, 29010
Actively Recruiting
47
Hospital Clinico Universitario de Valencia /ID# 277147
Valencia, Spain, 46010
Actively Recruiting
48
Hospital Clinico Universitario Lozano Blesa /ID# 277154
Zaragoza, Spain, 50009
Actively Recruiting
49
Changhua Christian Hospital /ID# 277145
Changhua, Taiwan, 500
Actively Recruiting
50
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138
Kaohsiung City, Taiwan, 807
Actively Recruiting
51
Taichung Veterans General Hospital /ID# 277142
Taichung, Taiwan, 407
Actively Recruiting
52
Mackay Memorial Hospital /ID# 277146
Taipei, Taiwan, 104
Actively Recruiting
53
Taipei Veterans General Hospital /ID# 277141
Taipei, Taiwan, 112
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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