Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
- Trial number:
- NCT04262856
- Trial phase:
- 2
- Study type:
- Immunotherapy, Targeted therapy
- Overall status:
- Recruiting
Study start date
May, 2020
Scientific title
A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer
Summary
This randomized phase 2 open-label study will evaluate the safety and efficacy of zimberelimab (AB122) monotherapy, domvanalimab (AB154) in combination with zimberelimab, and domvanalimab in combination with zimberelimab and etrumadenant (AB928) in front-line, PD-L1 positive, metastatic non-small cell lung cancer.
Male or female participants; age ≥ 18 yearsHistologically confirmed, treatment naïve, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. 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
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Masking:
None (Open Label),
Conditions
Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer, Lung Cancer, Non Small Cell Lung Cancer
Other study ID numbers
ARC-7 (AB154CSP0002)
Choose trial site (80)
Norton Cancer Institute
676 S Floyd St Suite 200, Louisville, KY 40202, USA
Joe Arrington Cancer Research and Treatment Center
4101 22nd Pl, Lubbock, TX 79410, USA
Tweed Hospital
Powell St & Florence Street, Tweed Heads NSW 2485, Australia
Queen Elizabeth Hospital
30 號 Gascoigne Rd, Yau Ma Tei, Hong Kong
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, South Korea
Korea University Anam Hospital
South Korea, Seoul, Seongbuk-gu, Anam-dong, 고려대로 73
Aurora Sinai Medical Center
88 Olympic-ro 43-gil, Pungnap 2(i)-dong, Songpa-gu, Seoul, South Korea
Raffles Hospital
585 North Bridge Rd, Singapore 188770
Curie Oncology (Novena)
38 Irrawaddy Rd, #08 21/29/30, Singapore 329563
Ochsner Clinic Foundation
New Orleans, LA 70121, USA
Gachon University Gil Medical Center
21 Namdong-daero 774beon-gil, Guwol-dong, Namdong-gu, Incheon, South Korea
Korea University Anam Hospital
South Korea, Seoul, Seongbuk-gu, 고려대로 73
Kangbuk Samsung Hospital
29 Saemunan-ro, Jongno-gu, Seoul, South Korea