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A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, 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 - AndroMETa-Lung-713

Status: Recruiting
Location: See all (110) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Highlands Oncology Group - Springdale /ID# 277132
RECRUITING
Springdale
California
City of Hope National Medical Center /ID# 277005
RECRUITING
Duarte
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928
RECRUITING
Irvine
Florida
Cancer Specialists of North Florida /ID# 277332
RECRUITING
Jacksonville
Cancer Care Centers of Brevard- Rockledge /ID# 277853
RECRUITING
Rockledge
Moffitt Cancer Center /ID# 276785
RECRUITING
Tampa
Indiana
Parkview Research Center /ID# 277651
RECRUITING
Fort Wayne
Minnesota
HealthPartners Cancer Research Center /ID# 277339
RECRUITING
Saint Louis Park
Nebraska
Nho - Revive Research Institute /ID# 277569
RECRUITING
Lincoln
New Hampshire
Dartmouth-Hitchcock Medical Center /ID# 277673
RECRUITING
Lebanon
New Jersey
Astera Cancer Care /ID# 277570
RECRUITING
East Brunswick
Tennessee
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
RECRUITING
Knoxville
SCRI Oncology Partners /ID# 276959
RECRUITING
Nashville
Washington
Fred Hutchinson Cancer Center. /ID# 277939
RECRUITING
Seattle
Northwest Cancer Specialists - Vancouver /ID# 277855
RECRUITING
Vancouver
Other Locations
Australia
St Vincent's Hospital Melbourne /ID# 277002
RECRUITING
Fitzroy
Canberra Hospital /ID# 277166
RECRUITING
Garran
Icon Cancer Centre Hobart /ID# 277549
RECRUITING
Hobart
St George Hospital - Kogarah /ID# 277168
RECRUITING
Kogarah
One Clinical Research - Nedlands /ID# 277598
RECRUITING
Nedlands
Mater Hospital Brisbane /ID# 276985
RECRUITING
South Brisbane
Sunshine Hospital /ID# 276894
RECRUITING
St Albans
Austria
Klinik Floridsdorf /ID# 276679
RECRUITING
Vienna
Belgium
Institut Jules Bordet /ID# 277283
RECRUITING
Anderlecht
Grand Hopital de Charleroi - Les Viviers /ID# 277282
RECRUITING
Charleroi
Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202
RECRUITING
Hasselt
Universitair Ziekenhuis Leuven /ID# 276874
RECRUITING
Leuven
Groupe Sante CHC - Clinique du MontLegia /ID# 278951
RECRUITING
Liège
China
Guangdong Provincial People's Hospital /ID# 277631
RECRUITING
Guangzhou
The First affiliated hospital of Nanchang University (Xianghu campus) /ID# 277491
RECRUITING
Nanchang
Shanghai Pulmonary Hospital /ID# 277488
RECRUITING
Shanghai
Xinjiang Medical University Cancer Hospital - Urumqi /ID# 277638
RECRUITING
Ürümqi
France
CHU Brest - Hopital de la Cavale Blanche /ID# 277883
RECRUITING
Brest
CHU de Lille - Institut Coeur Poumon /ID# 276868
RECRUITING
Lille
Hopital Arnaud de Villeneuve /ID# 276872
RECRUITING
Montpellier
Institut Curie /ID# 277623
RECRUITING
Paris
Germany
Universitaetsklinikum Koeln /ID# 276862
RECRUITING
Cologne
Universitaetsklinikum Hamburg-Eppendorf /ID# 276869
RECRUITING
Hamburg
Universitaetsklinikum Heidelberg /ID# 277275
RECRUITING
Heidelberg
Universitätsklinikum Jena /ID# 277281
RECRUITING
Jena
Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873
RECRUITING
Marburg
Universitaetsklinikum Wuerzburg /ID# 277213
RECRUITING
Würzburg
Israel
Rambam Health Care Campus- Haifa /ID# 276746
RECRUITING
Haifa
Meir Medical Center /ID# 277289
RECRUITING
Kefar Sava
Rabin Medical Center /ID# 276748
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center /ID# 276745
RECRUITING
Ramat Gan
Yitzhak Shamir Medical Center /ID# 276750
RECRUITING
Ẕerifin
Italy
Centro Di Riferimento Oncologico /ID# 276923
RECRUITING
Aviano
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119
RECRUITING
Candiolo
AOU Policlinico G. Rodolico - San Marco /ID# 277265
RECRUITING
Catania
AST Pesaro Urbino - Presidio Ospedaliero Santa Croce Di Fano /ID# 277338
RECRUITING
Fano
Istituto Europeo Di Oncologia /ID# 276788
RECRUITING
Milan
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 277296
RECRUITING
Rome
Ospedale Isola Tiberina - Gemelli Isola /ID# 277117
RECRUITING
Rome
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 277280
RECRUITING
Verona
Japan
National Cancer Center Hospital /ID# 277093
RECRUITING
Chuo-ku
Kitasato University Hospital /ID# 277241
RECRUITING
Sagamihara-shi
Hokkaido University Hospital /ID# 277240
RECRUITING
Sapporo
Wakayama Medical University Hospital /ID# 277238
RECRUITING
Wakayama
Netherlands
Leids Universitair Medisch Centrum /ID# 277270
RECRUITING
Leiden
Radboudumc /ID# 277639
RECRUITING
Nijmegen
Erasmus Medisch Centrum /ID# 276989
RECRUITING
Rotterdam
Universitair Medisch Centrum Utrecht /ID# 277114
RECRUITING
Utrecht
Poland
Uniwersyteckie Centrum Kliniczne /ID# 277210
RECRUITING
Gdansk
Pratia MCM Krakow /ID# 277118
RECRUITING
Krakow
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 277066
RECRUITING
Poznan
Gyncentrum Sp. z o.o. /ID# 277522
RECRUITING
Sosnowiec
Provita Centrum Medyczne /ID# 277494
RECRUITING
Warsaw
Portugal
Unidade Local de Saude de Braga, EPE /ID# 277217
RECRUITING
Braga
Unidade Local de Saude do Alto Ave, EPE /ID# 277249
RECRUITING
Guimarães
Unidade Local de Saude de Loures-Odivelas /ID# 277223
RECRUITING
Loures
Hospital Cuf Porto /ID# 277225
RECRUITING
Porto
Unidade Local de Saude de Santo Antonio /ID# 277216
RECRUITING
Porto
Unidade Local de Saude de Matosinhos EPE /ID# 277228
RECRUITING
Senhora Da Hora
Republic of Korea
Chungbuk National University Hospital /ID# 277372
RECRUITING
Cheongju-si
National Cancer Center /ID# 277353
RECRUITING
Goyang-si
Asan Medical Center /ID# 277371
RECRUITING
Seoul
Samsung Medical Center /ID# 277600
RECRUITING
Seoul
Seoul National University Hospital /ID# 277373
RECRUITING
Seoul
Yonsei University Health System Severance Hospital /ID# 277394
RECRUITING
Seoul
Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 277052
RECRUITING
Belgrade
University Clinical Center Serbia /ID# 277051
RECRUITING
Belgrade
Institute For Pulmonary Diseases Of Vojvodina /ID# 277047
RECRUITING
Kamenitz
University Clinical Center Kragujevac /ID# 277162
RECRUITING
Kragujevac
University Clinical Center Nis /ID# 277200
RECRUITING
Niš
Spain
Hospital Universitari Vall d Hebron /ID# 277156
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre /ID# 277155
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal /ID# 277153
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria /ID# 277159
RECRUITING
Málaga
Hospital Universitari Parc Tauli /ID# 277177
RECRUITING
Sabadell
Complejo Hospitalario Universitario de Santiago /ID# 277173
RECRUITING
Santiago De Compostela
Hospital Clinico Universitario de Valencia /ID# 277147
RECRUITING
Valencia
Hospital Clinico Universitario Lozano Blesa /ID# 277154
RECRUITING
Zaragoza
Taiwan
Changhua Christian Hospital /ID# 277145
RECRUITING
Changhua
Kaohsiung Chang Gung Memorial Hospital /ID# 277472
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital /ID# 277142
RECRUITING
Taichung
Mackay Memorial Hospital /ID# 277146
RECRUITING
Taipei
National Taiwan University Cancer Center (Ntucc) /ID# 277134
RECRUITING
Taipei
Taipei Veterans General Hospital /ID# 277141
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital /ID# 277135
RECRUITING
Taoyuan City
Turkey
Adana Sehir Hastanesi /ID# 276957
RECRUITING
Adana
Sakarya Universitesi Tip Fakultesi - Korucuk Kampusu /ID# 276962
RECRUITING
Adapazarı
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 276961
RECRUITING
Ankara
Gazi University Medical Faculty /ID# 276943
RECRUITING
Ankara
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276956
RECRUITING
Istanbul
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 277063
RECRUITING
Istanbul
Samsun Medical Park Hastanesi /ID# 277201
RECRUITING
Samsun
United Kingdom
St Bartholomews Hospital - Barts Health /ID# 277301
RECRUITING
London
The Christie NHS Foundation Trust - Christie Hospital /ID# 277304
RECRUITING
Manchester
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2030-09
Participants
Target number of participants: 490
Treatments
Experimental: Phase 2: Telisotuzumab Adizutecan Dose A
Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration.
Experimental: Phase 2: Telisotuzumab Adizutecan Dose B
Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration.
Experimental: Phase 2: Telisotuzumab Adizutecan Dose A + Osimertinib
Participants will receive telisotuzumab adizutecan dose A in combination with osimertinib, as part of the approximately 69 month study duration.
Experimental: Phase 2: Telisotuzumab Adizutecan Dose B + Osimertinib
Participants will receive telisotuzumab adizutecan dose B in combination with osimertinib, as part of the approximately 69 month study duration.
Experimental: Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose
Participants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration.
Experimental: Phase 3: Stand of Care (SOC)
Participants will receive investigator's choice of SOC, as part of the approximately 69 month study duration.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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