A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Recruiting · NCT07155187 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
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 as a monotherapy or in combination with osimertinib 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 as a monotherapy or in combination with osimertinib. 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 490 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 as a monotherapy or in combination with oral osimertinib. 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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 recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable.
- 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. Participant who has received prior third-generation EGFR TKI therapy in the adjuvant setting must have progressed while on treatment.
- 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.
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.
- Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable.
- Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids.
- Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
Where it is running
60 locations listed across 10 US states.
- Highlands Oncology Group - Springdale /ID# 277132 - Springdale, Arkansas, United States
- City of Hope National Medical Center /ID# 277005 - Duarte, California, United States
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928 - Irvine, California, United States
- Cancer Specialists of North Florida /ID# 277332 - Jacksonville, Florida, United States
- Cancer Care Centers of Brevard- Rockledge /ID# 277853 - Rockledge, Florida, United States
- Moffitt Cancer Center /ID# 276785 - Tampa, Florida, United States
- Parkview Research Center /ID# 277651 - Fort Wayne, Indiana, United States
- HealthPartners Cancer Research Center /ID# 277339 - Saint Louis Park, Minnesota, United States
- Nho - Revive Research Institute /ID# 277569 - Lincoln, Nebraska, United States
- Dartmouth-Hitchcock Medical Center /ID# 277673 - Lebanon, New Hampshire, United States
- Astera Cancer Care /ID# 277570 - East Brunswick, New Jersey, United States
- Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891 - Knoxville, Tennessee, United States
- SCRI Oncology Partners /ID# 276959 - Nashville, Tennessee, United States
- Fred Hutchinson Cancer Center. /ID# 277939 - Seattle, Washington, United States
- Northwest Cancer Specialists - Vancouver /ID# 277855 - Vancouver, Washington, United States
- Adana Sehir Hastanesi /ID# 276957 - Adana, Turkey (Türkiye)
- Gazi University Medical Faculty /ID# 276943 - Ankara, Turkey (Türkiye)
- Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 276961 - Ankara, Turkey (Türkiye)
- Hospital Universitari Vall d Hebron /ID# 277156 - Barcelona, Spain
- Unidade Local de Saude de Braga, EPE /ID# 277217 - Braga, Portugal
- AOU Policlinico G. Rodolico - San Marco /ID# 277265 - Catania, Italy
- Changhua Christian Hospital /ID# 277145 - Changhua, Taiwan
- Rambam Health Care Campus- Haifa /ID# 276746 - Haifa, Israel
- Universitaetsklinikum Hamburg-Eppendorf /ID# 276869 - Hamburg, Germany
- Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276956 - Istanbul, Turkey (Türkiye)
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 277063 - Istanbul, Turkey (Türkiye)
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138 - Kaohsiung City, Taiwan
- Kaohsiung Chang Gung Memorial Hospital /ID# 277472 - Kaohsiung City, Taiwan
- Hospital Universitario Ramon y Cajal /ID# 277153 - Madrid, Spain
- Hospital Universitario 12 de Octubre /ID# 277155 - Madrid, Spain
- The Christie NHS Foundation Trust - Christie Hospital /ID# 277304 - Manchester, United Kingdom
- Hospital Universitario Virgen de la Victoria /ID# 277159 - Málaga, Spain
- Unidade Local de Saude de Santo Antonio /ID# 277216 - Porto, Portugal
- Hospital Cuf Porto /ID# 277225 - Porto, Portugal
- Samsun Medical Park Hastanesi /ID# 277201 - Samsun, Turkey (Türkiye)
- Taichung Veterans General Hospital /ID# 277142 - Taichung, Taiwan
- Mackay Memorial Hospital /ID# 277146 - Taipei, Taiwan
- National Taiwan University Cancer Center (Ntucc) /ID# 277134 - Taipei, Taiwan
- Taipei Veterans General Hospital /ID# 277141 - Taipei, Taiwan
- Linkou Chang Gung Memorial Hospital /ID# 277135 - Taoyuan City, Taiwan
- Universitair Medisch Centrum Utrecht /ID# 277114 - Utrecht, Netherlands
- Hospital Clinico Universitario de Valencia /ID# 277147 - Valencia, Spain
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 277280 - Verona, Italy
- Hospital Clinico Universitario Lozano Blesa /ID# 277154 - Zaragoza, Spain
- Complejo Hospitalario Universitario de Santiago /ID# 277173 - Santiago de Compostela, A Coruna, Spain
- Canberra Hospital /ID# 277166 - Garran, Australian Capital Territory, Australia
- Universitaetsklinikum Heidelberg /ID# 277275 - Heidelberg, Baden-Wurttemberg, Germany
- Hospital Universitari Parc Tauli /ID# 277177 - Sabadell, Barcelona, Spain
- Universitaetsklinikum Wuerzburg /ID# 277213 - Würzburg, Bavaria, Germany
- University Clinical Center Serbia /ID# 277051 - Belgrade, Beograd, Serbia
- Clinical Hospital Center - Bežanijska Kosa /ID# 277052 - Belgrade, Beograd, Serbia
- Unidade Local de Saude do Alto Ave, EPE /ID# 277249 - Guimarães, Braga District, Portugal
- Institut Jules Bordet /ID# 277283 - Anderlecht, Brussels Capital, Belgium
- Meir Medical Center /ID# 277289 - Kefar Sava, Central District, Israel
- Rabin Medical Center /ID# 276748 - Petah Tikva, Central District, Israel
- Yitzhak Shamir Medical Center /ID# 276750 - Ẕerifin, Central District, Israel
- CHU Brest - Hopital de la Cavale Blanche /ID# 277883 - Brest, Finistere, France
- Radboudumc /ID# 277639 - Nijmegen, Gelderland, Netherlands
- St Bartholomews Hospital - Barts Health /ID# 277301 - London, Greater London, United Kingdom
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 277066 - Poznan, Greater Poland Voivodeship, Poland
Showing 60 of 110 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →