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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
NCT07155187 · AbbVie
In plain English
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Official title
Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI
About this study
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.
Eligibility criteria
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.
* Provide archived or recently obtained tumor tissue during Screening.
* Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
* Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
* Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded.
* If the prior third-generation EGFR TKI was administered in the adjuvant setting, progression must have occurred while on treatment.
Exclusion Criteria:
* Tumor(s) have adenosquamous or squamous histology or sarcomatoid features.
* Received more than 1 line of systemic therapy in the locally advanced or metastatic setting.
* Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
Study design
Enrollment target: 430 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-10
Estimated completion: 2030-09
Last updated: 2026-03-11
Interventions
Drug: Telisotuzumab AdizutecanDrug: Standard of Care
Primary outcomes
- • Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR) (Up to Approximately 69 Months)
- • Phase 3: Progression-Free Survival (PFS) as assessed by BICR (Up to Approximately 69 Months)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (53)
Highlands Oncology Group - Springdale /ID# 277132Recruiting
Springdale, Arkansas, United States
Cancer Care Centers of Brevard- Rockledge /ID# 277853Recruiting
Rockledge, Florida, United States
HealthPartners Cancer Research Center /ID# 277339Recruiting
Saint Louis Park, Minnesota, United States
Nho - Revive Research Institute /ID# 277569Recruiting
Lincoln, Nebraska, United States
Astera Cancer Care /ID# 277570Recruiting
East Brunswick, New Jersey, United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891Recruiting
Knoxville, Tennessee, United States
SCRI Oncology Partners /ID# 276959Recruiting
Nashville, Tennessee, United States
Northwest Cancer Specialists - Vancouver /ID# 277855Recruiting
Vancouver, Washington, United States
Canberra Hospital /ID# 277166Recruiting
Garran, Australian Capital Territory, Australia
St George Hospital /ID# 277168Recruiting
Kogarah, New South Wales, Australia
Mater Hospital Brisbane /ID# 276985Recruiting
South Brisbane, Queensland, Australia
Icon Cancer Centre Hobart /ID# 277549Recruiting
Hobart, Tasmania, Australia
St Vincent's Hospital Melbourne /ID# 277002Recruiting
Fitzroy, Victoria, Australia
Sunshine Hospital /ID# 276894Recruiting
St Albans, Victoria, Australia
One Clinical Research - Nedlands /ID# 277598Recruiting
Nedlands, Western Australia, Australia
Klinik Floridsdorf /ID# 276679Recruiting
Vienna, State of Vienna, Austria
Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202Recruiting
Hasselt, Limburg, Belgium
Universitair Ziekenhuis Leuven /ID# 276874Recruiting
Leuven, Vlaams-Brabant, Belgium
Guangdong Provincial People'S Hospital /ID# 277631Recruiting
Guangzhou, Guangdong, China
Universitaetsklinikum Heidelberg /ID# 277275Recruiting
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Wuerzburg /ID# 277213Recruiting
Würzburg, Bavaria, Germany
Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873Recruiting
Marburg, Hesse, Germany
Universitaetsklinikum Koeln /ID# 276862Recruiting
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Jena /ID# 277281Recruiting
Jena, Thuringia, Germany
Meir Medical Center /ID# 277289Recruiting
Kfar Saba, Central District, Israel
Rabin Medical Center /ID# 276748Recruiting
Petah Tikva, Central District, Israel
Yitzhak Shamir Medical Center /ID# 276750Recruiting
Ẕerifin, Central District, Israel
The Chaim Sheba Medical Center /ID# 276745Recruiting
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 276746Recruiting
Haifa, Israel
Ospedale Isola Tiberina - Gemelli Isola /ID# 277117Recruiting
Rome, Roma, Italy
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119Recruiting
Candiolo, Torino, Italy
Hokkaido University Hospital /ID# 277240Recruiting
Sapporo, Hokkaido, Japan
Kitasato University Hospital /ID# 277241Recruiting
Sagamihara-shi, Kanagawa, Japan
National Cancer Center Hospital /ID# 277093Recruiting
Chuo-Ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 277238Recruiting
Wakayama, Wakayama, Japan
Unidade Local de Saude do Alto Ave, EPE /ID# 277249Recruiting
Guimarães, Braga District, Portugal
Unidade Local de Saude de Loures-Odivelas, EPE /ID# 277223Recruiting
Loures, Lisbon District, Portugal
Unidade Local de Saude de Matosinhos, EPE /ID# 277228Recruiting
Senhora da Hora, Porto District, Portugal
Unidade Local de Saude de Braga, EPE /ID# 277217Recruiting
Braga, Portugal
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 277216Recruiting
Porto, Portugal
National Cancer Center /ID# 277353Recruiting
Goyang-si, Gyeonggido, South Korea
Chungbuk National University Hospital /ID# 277372Recruiting
Cheongju-si, North Chungcheong, South Korea
Seoul National University Hospital /ID# 277373Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 277371Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 277600Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitario Virgen de la Victoria /ID# 277159Recruiting
Málaga, Spain
Hospital Clinico Universitario de Valencia /ID# 277147Recruiting
Valencia, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 277154Recruiting
Zaragoza, Spain
Changhua Christian Hospital /ID# 277145Recruiting
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138Recruiting
Kaohsiung City, Taiwan
Taichung Veterans General Hospital /ID# 277142Recruiting
Taichung, Taiwan
Mackay Memorial Hospital /ID# 277146Recruiting
Taipei, Taiwan
Taipei Veterans General Hospital /ID# 277141Recruiting
Taipei, Taiwan