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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telisotuzumab Adizutecan, Standard of Care, Osimertinib.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Austria, Belgium, China +14
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug Telisotuzumab Adizutecan
Intravenous (IV) Infusion - Drug Standard of Care
Standard of Care - Drug Osimertinib
Oral
Primary outcome measures
- Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR) [Time frame: Up to Approximately 69 Months]
- Phase 3: Progression-Free Survival (PFS) as assessed by the BICR [Time frame: Up to Approximately 69 Months]
Secondary outcome measures (8)
- Phase 2 and 3: Overall Survival (OS) [Time frame: Up to Approximately 69 Months]
- Phase 2: PFS as assessed by the BICR [Time frame: Up to Approximately 69 Months]
- Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per RECIST v1.1 [Time frame: Up to Approximately 69 Months]
- Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1 [Time frame: Up to Approximately 69 Months]
- Phase 3: OR Assessed by the BICR [Time frame: Up to Approximately 69 Months]
- Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) [Time frame: Up to Week 12]
- Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13) [Time frame: Up to Week 12]
- Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30 [Time frame: Up to Week 12]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- Highlands Oncology Group - Springdale /ID# 277132 — Springdale
- City of Hope National Medical Center /ID# 277005 — Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928 — Irvine
- Cancer Specialists of North Florida /ID# 277332 — Jacksonville
- Cancer Care Centers of Brevard- Rockledge /ID# 277853 — Rockledge
- Moffitt Cancer Center /ID# 276785 — Tampa
- Parkview Research Center /ID# 277651 — Fort Wayne
- HealthPartners Cancer Research Center /ID# 277339 — Saint Louis Park
- … and 7 more centers
Italy · 8 centers
- Istituto Europeo Di Oncologia /ID# 276788 — Milan
- AST Pesaro Urbino - Presidio Ospedaliero Santa Croce Di Fano /ID# 277338 — Fano
- Centro Di Riferimento Oncologico /ID# 276923 — Aviano
- IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 27729 — Rome
- Ospedale Isola Tiberina - Gemelli Isola /ID# 277117 — Rome
- Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119 — Candiolo
- AOU Policlinico G. Rodolico - San Marco /ID# 277265 — Catania
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 277280 — Verona
Spain · 8 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 8 centers
Center list to be confirmed — check the primary protocol.
Australia · 7 centers
- Canberra Hospital /ID# 277166 — Garran
- St George Hospital - Kogarah /ID# 277168 — Kogarah
- Mater Hospital Brisbane /ID# 276985 — South Brisbane
- Icon Cancer Centre Hobart /ID# 277549 — Hobart
- St Vincent's Hospital Melbourne /ID# 277002 — Fitzroy
- Sunshine Hospital /ID# 276894 — St Albans
- One Clinical Research - Nedlands /ID# 277598 — Nedlands
Turkey (Türkiye) · 7 centers
Center list to be confirmed — check the primary protocol.
Germany · 6 centers
- Universitaetsklinikum Heidelberg /ID# 277275 — Heidelberg
- Universitaetsklinikum Wuerzburg /ID# 277213 — Würzburg
- Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873 — Marburg
- Universitaetsklinikum Koeln /ID# 276862 — Cologne
- Universitätsklinikum Jena /ID# 277281 — Jena
- Universitaetsklinikum Hamburg-Eppendorf /ID# 276869 — Hamburg
Portugal · 6 centers
- Unidade Local de Saude do Alto Ave, EPE /ID# 277249 — Guimarães
- Unidade Local de Saude de Loures-Odivelas /ID# 277223 — Loures
- Unidade Local de Saude de Matosinhos EPE /ID# 277228 — Senhora da Hora
- Unidade Local de Saude de Braga, EPE /ID# 277217 — Braga
- Unidade Local de Saude de Santo Antonio /ID# 277216 — Porto
- Hospital Cuf Porto /ID# 277225 — Porto
South Korea · 6 centers
- National Cancer Center /ID# 277353 — Goyang-si
- … and 5 more centers
Belgium · 5 centers
- Institut Jules Bordet /ID# 277283 — Anderlecht
- Grand Hopital de Charleroi - Les Viviers /ID# 277282 — Charleroi
- Groupe Sante CHC - Clinique du MontLegia /ID# 278951 — Liège
- Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202 — Hasselt
- Universitair Ziekenhuis Leuven /ID# 276874 — Leuven
Israel · 5 centers
- Meir Medical Center /ID# 277289 — Kefar Sava
- Rabin Medical Center /ID# 276748 — Petah Tikva
- Yitzhak Shamir Medical Center /ID# 276750 — Ẕerifin
- The Chaim Sheba Medical Center /ID# 276745 — Ramat Gan
- Rambam Health Care Campus- Haifa /ID# 276746 — Haifa
Poland · 5 centers
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 2770 — Poznan
- Pratia MCM Krakow /ID# 277118 — Krakow
- Provita Centrum Medyczne /ID# 277494 — Warsaw
- Uniwersyteckie Centrum Kliniczne /ID# 277210 — Gdansk
- Gyncentrum Sp. z o.o. /ID# 277522 — Sosnowiec
Serbia · 5 centers
- University Clinical Center Serbia /ID# 277051 — Belgrade
- Clinical Hospital Center - Bežanijska Kosa /ID# 277052 — Belgrade
- University Clinical Center Nis /ID# 277200 — Niš
- Institute For Pulmonary Diseases Of Vojvodina /ID# 277047 — Kamenitz
- University Clinical Center Kragujevac /ID# 277162 — Kragujevac
China · 4 centers
- Guangdong Provincial People's Hospital /ID# 277631 — Guangzhou
- The First affiliated hospital of Nanchang University (Xianghu campus) /ID# 277491 — Nanchang
- Shanghai Pulmonary Hospital /ID# 277488 — Shanghai
- Xinjiang Medical University Cancer Hospital - Urumqi /ID# 277638 — Ürümqi
France · 4 centers
- CHU Brest - Hopital de la Cavale Blanche /ID# 277883 — Brest
- CHU de Lille - Institut Coeur Poumon /ID# 276868 — Lille
- Hopital Arnaud de Villeneuve /ID# 276872 — Montpellier
- Institut Curie /ID# 277623 — Paris
Japan · 4 centers
- Hokkaido University Hospital /ID# 277240 — Sapporo
- Kitasato University Hospital /ID# 277241 — Sagamihara-shi
- National Cancer Center Hospital /ID# 277093 — Chuo-Ku
- Wakayama Medical University Hospital /ID# 277238 — Wakayama
Netherlands · 4 centers
- Radboudumc /ID# 277639 — Nijmegen
- Leids Universitair Medisch Centrum /ID# 277270 — Leiden
- Erasmus Medisch Centrum /ID# 276989 — Rotterdam
- Universitair Medisch Centrum Utrecht /ID# 277114 — Utrecht
United Kingdom · 2 centers
Center list to be confirmed — check the primary protocol.
Austria · 1 center
- Klinik Floridsdorf /ID# 276679 — Vienna
Identifiers
NCT: NCT07155187 · M25-713 · 2025-521124-29