Lung Cancer Clinical Trial
Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer
Summary
This is a phase 3 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) compared to pembrolizumab in front-line, PD-L1-high, locally advanced or metastatic NSCLC.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed, treatment naïve, locally advanced or metastatic (stage IIIB IV per AJCC version 8), squamous or non-squamous NSCLC with documented high PD L1 expression (TC ≥ 50%) as determined by the VENTANA SP263 IHC assay, as assessed by central laboratories).
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Must have at least 1 measurable lesion per RECIST v1.1
Adequate organ and marrow function
If a participant has brain or meningeal metastases, the participant must meet the following criteria:
Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose.
Participants with previously treated brain metastases may participate provided they have stable central nervous system (CNS) disease for at least 4 weeks prior to enrollment. Stable CNS disease is defined as resolution of all neurologic symptoms to baseline, having no evidence of new or enlarging brain metastases, and not requiring use of corticosteroids for CNS disease for at least 14 days prior to the start of study treatment. Participants who have had brain metastases resected or have received whole brain radiotherapy ending at least 4 weeks (or stereotactic radiotherapy ending at least 2 weeks) prior to initiation of study treatment are permitted.
Carcinomatous meningitis is excluded regardless of clinical stability.
Exclusion Criteria:
Presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved by local health authority and available
Use of any live vaccines against infectious diseases within 28 days of first dose
Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.
Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 7 Locations for this study
Thousand Oaks California, 91360, United States
Columbus Georgia, 31904, United States
Hinsdale Illinois, 60521, United States
Canton Ohio, 44718, United States
Cleveland Ohio, 44106, United States
Kingwood Texas, 77339, United States
Roanoke Virginia, 24014, United States
Dhaka , , Bangladesh
Dhaka , , Bangladesh
Dhaka , , Bangladesh
Barretos , , Brazil
Belo Horizonte , , Brazil
Brasília , , Brazil
Curitiba , , Brazil
Florianópolis , , Brazil
Ijuí , , Brazil
Jaú , , Brazil
Passo Fundo , , Brazil
Porto Alegre , , Brazil
Santa Cruz do Sul , , Brazil
Santo André , , Brazil
São José Do Rio Preto , , Brazil
São Paulo , , Brazil
São Paulo , , Brazil
Athens , , Greece
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Larissa , , Greece
Patra , , Greece
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Busan , , Korea, Republic of
Cheongju , , Korea, Republic of
Gyeonggi-do , , Korea, Republic of
Incheon , , Korea, Republic of
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Jeonju , , Korea, Republic of
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Suwon-Si , , Korea, Republic of
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Cheras , , Malaysia
Johor Bahru , , Malaysia
Kuala Lumpur , , Malaysia
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Kuantan , , Malaysia
Kuching , , Malaysia
Tanjung Bungah , , Malaysia
Guadalajara , , Mexico
Mexico City , , Mexico
Monterrey , , Mexico
Oaxaca , , Mexico
San Luis Potosi , , Mexico
Arequipa , , Peru
San Borja , , Peru
San Isidro , , Peru
Baguio City , , Philippines
Cebu City , , Philippines
Davao City , , Philippines
Makati City , , Philippines
Manila , , Philippines
Manila , , Philippines
Quezon City , , Philippines
Belgrade , , Serbia
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Kragujevac , , Serbia
Nis , , Serbia
Sremska Kamenica , , Serbia
Uzice , , Serbia
Banka , , Slovakia
Kosice , , Slovakia
Michalovce , , Slovakia
Partizanske , , Slovakia
Trnava , , Slovakia
Cape Town , , South Africa
George , , South Africa
Johannesburg , , South Africa
Johannesburg , , South Africa
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Pretoria , , South Africa
Pretoria , , South Africa
Pretoria , , South Africa
Kaohsiung City , , Taiwan
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Taichung City , , Taiwan
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Taipei , , Taiwan
Bangkok , , Thailand
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Chanthaburi , , Thailand
Chiang Mai , , Thailand
Chiang Mai , , Thailand
Khon Kaen , , Thailand
Lampang , , Thailand
Nakhon Ratchasima , , Thailand
Phitsanulok , , Thailand
Phitsanulok , , Thailand
Saraburi , , Thailand
Songkhla , , Thailand
Ubon Ratchathani , , Thailand
Udon Thani , , Thailand
Adana , , Turkey
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Ankara , , Turkey
Ankara , , Turkey
Ankara , , Turkey
Ankara , , Turkey
Diyarbakir , , Turkey
Edirne , , Turkey
Istanbul , , Turkey
Istanbul , , Turkey
Istanbul , , Turkey
Istanbul , , Turkey
Kocaeli , , Turkey
Malatya , , Turkey
Mersin , , Turkey
Cần Thơ , , Vietnam
Ho Chi Minh City , , Vietnam
Huế , , Vietnam
Hà Nội , , Vietnam
Hà Nội , , Vietnam
Hà Nội , , Vietnam
Hà Nội , , Vietnam
Hà Nội , , Vietnam
Hà Nội , , Vietnam
Hà Nội , , Vietnam
Hà Nội , , Vietnam
Hà Nội , , Vietnam
Hà Nội , , Vietnam
Hà Nội , , Vietnam
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