Study to Evaluate Monotherapy Compared to Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
Study Details
Study Description
Brief Summary
This Randomized Phase 3 Open-label Study will Evaluate the Efficacy of Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined with AB154 in Front-Line, PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Arm A (Platinum-based Chemotherapy) Participants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion. |
Drug: Carboplatin
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
Drug: Pemetrexed
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
Drug: Paclitaxel
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
|
Experimental: Arm B (Zimberelimab Monotherapy) Participants will receive zimberelimab monotherapy by IV infusion. |
Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Names:
|
Active Comparator: Arm C (Zimberelimab + AB154 Combination Therapy) Participants will receive zimberelimab in combination with AB154 by IV infusion. |
Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Names:
Drug: Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Survival (OS) [From randomization until death from any cause (up to approximately 7 years)]
Arm A vs. Arm B
- Progression-free Survival (PFS) [From randomization until death from any cause (up to approximately 7 years)]
Arm B vs. Arm C - PFS as assessed by RECIST v1.1 by the investigator
- Overall Survival (OS) [From randomization until death from any cause (up to approximately 7 years)]
Arm B vs. Arm C
Secondary Outcome Measures
- Confirmed Overall Response Rate (ORR) [From randomization until death from any cause (up to approximately 7 years)]
Arm A vs. Arm B - ORR as assessed by RECIST v1.1 by the investigator
- Progression-free Survival (PFS) [From randomization until death from any cause (up to approximately 7 years)]
Arm A vs. Arm B - PFS as assessed by RECIST v1.1 by the investigator
- Confirmed Overall Response Rate (ORR) [From randomization until death from any cause (up to approximately 7 years)]
Arm B vs. Arm C - ORR as assessed by RECIST v1.1 by the investigator
- PFS at Milestone Timepoints [6 months and 1 year]
Arm A vs. Arm B - PFS as assessed by RECIST v1.1 by the investigator
- PFS at Milestone Timepoints [6 months and 1 year]
Arm B vs. Arm C - PFS as assessed by RECIST v1.1 by the investigator
- Overall Survival at Milestone Timepoints [1 year, 2 years, and 3 years]
Arm A vs. Arm B
- Overall Survival at Milestone Timepoints [1 year, 2 years, and 3 years]
Arm B vs. Arm C
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed, squamous or nonsquamous, treatment-naive PD-L1 positive, NSCLC that is locally advanced or metastatic without sensitizing epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation
-
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
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Investigational site # 2 | Dhaka | Bangladesh | ||
2 | Investigational site # 3 | Dhaka | Bangladesh | ||
3 | Investigational site #1 | Dhaka | Bangladesh | ||
4 | Investigational site | Gomel | Belarus | ||
5 | IInvestigational site # 2 | Minsk | Belarus | ||
6 | Investigational site # 1 | Minsk | Belarus | ||
7 | Investigational site | Mogilev | Belarus | ||
8 | Investigational site | Vitebsk | Belarus | ||
9 | Investigational site | Barretos | Brazil | ||
10 | Investigational site | Belo Horizonte | Brazil | ||
11 | Investigational site | Brasilia | Brazil | ||
12 | Investigational site | Curitiba | Brazil | ||
13 | Investigational site | Florianopolis | Brazil | ||
14 | Investigational site | Ijui | Brazil | ||
15 | Investigational site | Jau | Brazil | ||
16 | Investigational site | Passo Fundo | Brazil | ||
17 | Investigational site | Porto Alegre | Brazil | ||
18 | Investigational site | Santa Cruz do Sul | Brazil | ||
19 | Investigational site | Santo Andre | Brazil | ||
20 | Investigational site | Sao Jose do Rio Preto | Brazil | ||
21 | Investigational site # 1 | Sao Paulo | Brazil | ||
22 | Investigational site # 2 | Sao Paulo | Brazil | ||
23 | Investigational site # 1 | Alexandria | Egypt | ||
24 | Investigational site # 2 | Alexandria | Egypt | ||
25 | Investigational site # 1 | Cairo | Egypt | ||
26 | Investigational site # 2 | Cairo | Egypt | ||
27 | Investigational site # 3 | Cairo | Egypt | ||
28 | Investigational site # 4 | Cairo | Egypt | ||
29 | Investigational site | Luxor | Egypt | ||
30 | Investigational site | Mansoura | Egypt | ||
31 | Investigational site | Shibin El Kom | Egypt | ||
32 | Investigational site # 1 | Athens | Greece | ||
33 | Investigational site # 2 | Athens | Greece | ||
34 | Investigational site # 3 | Athens | Greece | ||
35 | Investigational site # 4 | Athens | Greece | ||
36 | Investigational site # 5 | Athens | Greece | ||
37 | Investigational site | Larissa | Greece | ||
38 | Investigational site | Patra | Greece | ||
39 | Investigational site # 5 | Hong Kong | Hong Kong | ||
40 | Investigational site #1 | Hong Kong | Hong Kong | ||
41 | Investigational site #2 | Hong Kong | Hong Kong | ||
42 | Investigational site #3 | Hong Kong | Hong Kong | ||
43 | Investigational site #4 | Hong Kong | Hong Kong | ||
44 | Investigational site | Busan | Korea, Republic of | ||
45 | Investigational site | Cheongju | Korea, Republic of | ||
46 | Investigational site | Gyeonggi-do | Korea, Republic of | ||
47 | Investigational site # 1 | Incheon | Korea, Republic of | ||
48 | Investigational site # 2 | Incheon | Korea, Republic of | ||
49 | Investigational site # 3 | Incheon | Korea, Republic of | ||
50 | Investigational site | Jeonju | Korea, Republic of | ||
51 | Investigational site | Seongnam | Korea, Republic of | ||
52 | Investigational site # 1 | Seoul | Korea, Republic of | ||
53 | Investigational site # 2 | Seoul | Korea, Republic of | ||
54 | Investigational site # 3 | Seoul | Korea, Republic of | ||
55 | Investigational site # 4 | Seoul | Korea, Republic of | ||
56 | Investigational site # 1 | Suwon-Si | Korea, Republic of | ||
57 | Investigational site # 2 | Suwon-Si | Korea, Republic of | ||
58 | Investigational site | Cheras | Malaysia | ||
59 | Investigational site | Johor Bahru | Malaysia | ||
60 | Investigational site #1 | Kuala Lumpur | Malaysia | ||
61 | Investigational site #2 | Kuala Lumpur | Malaysia | ||
62 | Investigational site #3 | Kuala Lumpur | Malaysia | ||
63 | Investigational site | Kuantan | Malaysia | ||
64 | Investigational site | Kuching | Malaysia | ||
65 | Investigational site | Pulau Pinang | Malaysia | ||
66 | Investigational site | Tanjung Bungah | Malaysia | ||
67 | Investigational site | Guadalajara | Mexico | ||
68 | Investigational site | Mexico city | Mexico | ||
69 | Investigational site | Monterrey | Mexico | ||
70 | Investigational site | Oaxaca | Mexico | ||
71 | Investigational site | San Luis Potosi | Mexico | ||
72 | Investigational site | Arequipa | Peru | ||
73 | Investigational site | San Borja | Peru | ||
74 | Investigational site | San Isidro | Peru | ||
75 | Investigational site | Baguio City | Philippines | ||
76 | Investigational site | Cebu City | Philippines | ||
77 | Investigational site | Davao City | Philippines | ||
78 | Investigational site | Makati City | Philippines | ||
79 | Investigational site # 1 | Manila | Philippines | ||
80 | Investigational site # 2 | Manila | Philippines | ||
81 | Investigational site | Quezon City | Philippines | ||
82 | Investigational site | Arkhangelsk | Russian Federation | ||
83 | Investigational site | Barnaul | Russian Federation | ||
84 | Investigational site | Belgorod | Russian Federation | ||
85 | Investigational site # 1 | Chelyabinsk | Russian Federation | ||
86 | Investigational site # 2 | Chelyabinsk | Russian Federation | ||
87 | Investigational site | Ivanovo | Russian Federation | ||
88 | Investigational site | Kazan | Russian Federation | ||
89 | Investigational site # 1 | Moscow | Russian Federation | ||
90 | Investigational site # 2 | Moscow | Russian Federation | ||
91 | Investigational site # 3 | Moscow | Russian Federation | ||
92 | Investigational site # 4 | Moscow | Russian Federation | ||
93 | Investigational site | Novosibirsk | Russian Federation | ||
94 | Investigational site | Omsk | Russian Federation | ||
95 | Investigational site | Pyatigorsk | Russian Federation | ||
96 | Investigational site # 1 | Saint Peterburg | Russian Federation | ||
97 | Investigational site # 2 | Saint Peterburg | Russian Federation | ||
98 | Investigational site # 3 | Saint Peterburg | Russian Federation | ||
99 | Investigational site # 4 | Saint Peterburg | Russian Federation | ||
100 | Investigational site # 5 | Saint Peterburg | Russian Federation | ||
101 | Investigational site | Samara | Russian Federation | ||
102 | Investigational site # 1 | Belgrade | Serbia | ||
103 | Investigational site # 2 | Belgrade | Serbia | ||
104 | Investigational site # 3 | Belgrade | Serbia | ||
105 | Investigational site | Kragujevac | Serbia | ||
106 | Investigational site | Nis | Serbia | ||
107 | Investigational site | Sremska Kamenica | Serbia | ||
108 | Investigational site | Uzice | Serbia | ||
109 | Investigational site | Banka | Slovakia | ||
110 | Investigational site | Kosice | Slovakia | ||
111 | Investigational site | Michalovce | Slovakia | ||
112 | Investigational site | Partizanske | Slovakia | ||
113 | Investigational site | Trnava | Slovakia | ||
114 | Investigational site | Cape Town | South Africa | ||
115 | Investigational site | George | South Africa | ||
116 | Investigational site # 1 | Johannesburg | South Africa | ||
117 | Investigational site # 2 | Johannesburg | South Africa | ||
118 | Investigational site # 3 | Johannesburg | South Africa | ||
119 | Investigational site # 4 | Johannesburg | South Africa | ||
120 | Investigational site # 1 | Pretoria | South Africa | ||
121 | Investigational site # 2 | Pretoria | South Africa | ||
122 | Investigational site # 3 | Pretoria | South Africa | ||
123 | Investigational site # 1 | Kaohsiung City | Taiwan | ||
124 | Investigational site # 2 | Kaohsiung City | Taiwan | ||
125 | Investigational site # 1 | Taichung City | Taiwan | ||
126 | Investigational site # 2 | Taichung City | Taiwan | ||
127 | Investigational site # 3 | Taichung City | Taiwan | ||
128 | Investigational site | Taipei | Taiwan | ||
129 | Investigational site # 1 | Bangkok | Thailand | ||
130 | Investigational site # 2 | Bangkok | Thailand | ||
131 | Investigational site # 3 | Bangkok | Thailand | ||
132 | Investigational site # 4 | Bangkok | Thailand | ||
133 | Investigational site | Chanthaburi | Thailand | ||
134 | Investigational site # 1 | Chiang Mai | Thailand | ||
135 | Investigational site # 2 | Chiang Mai | Thailand | ||
136 | Investigational site | Khon Kaen | Thailand | ||
137 | Investigational site | Lampang | Thailand | ||
138 | Investigational site | Mueang | Thailand | ||
139 | Investigational site # 1 | Phitsanulok | Thailand | ||
140 | Investigational site # 2 | Phitsanulok | Thailand | ||
141 | Investigational site | Saraburi | Thailand | ||
142 | Investigational site | Songkhla | Thailand | ||
143 | Investigational site | Ubon Ratchathani | Thailand | ||
144 | Investigational site | Udon Thani | Thailand | ||
145 | Investigational site # 1 | Adana | Turkey | ||
146 | Investigational site # 2 | Adana | Turkey | ||
147 | Investigational site # 3 | Adana | Turkey | ||
148 | Investigational site # 1 | Ankara | Turkey | ||
149 | Investigational site # 2 | Ankara | Turkey | ||
150 | Investigational site # 3 | Ankara | Turkey | ||
151 | Investigational site # 4 | Ankara | Turkey | ||
152 | Investigational site | Diyarbakir | Turkey | ||
153 | Investigational site | Edirne | Turkey | ||
154 | Investigational site # 1 | Istanbul | Turkey | ||
155 | Investigational site # 2 | Istanbul | Turkey | ||
156 | Investigational site # 3 | Istanbul | Turkey | ||
157 | Investigational site # 4 | Istanbul | Turkey | ||
158 | Investigational site | Kocaeli | Turkey | ||
159 | Investigational site | Malatya | Turkey | ||
160 | Investigational site | Mersin | Turkey | ||
161 | Investigational site | Dnipro | Ukraine | ||
162 | Investigational site | Kharkiv | Ukraine | ||
163 | Investigational site | Kherson | Ukraine | ||
164 | Investigational site | Kiev | Ukraine | ||
165 | Investigational site | Kryvyi Rih | Ukraine | ||
166 | Investigational site | Lutsk | Ukraine | ||
167 | Investigational site | Sumy | Ukraine | ||
168 | Investigational site | Vinnytsia | Ukraine | ||
169 | Investigational site | Zaporizhzhia | Ukraine | ||
170 | Investigational site | Can Tho | Vietnam | ||
171 | Investigational site # 10 | HaNoi | Vietnam | ||
172 | Investigational site # 11 | HaNoi | Vietnam | ||
173 | Investigational site # 1 | HaNoi | Vietnam | ||
174 | Investigational site # 2 | HaNoi | Vietnam | ||
175 | Investigational site # 3 | HaNoi | Vietnam | ||
176 | Investigational site # 4 | HaNoi | Vietnam | ||
177 | Investigational site # 5 | HaNoi | Vietnam | ||
178 | Investigational site # 6 | HaNoi | Vietnam | ||
179 | Investigational site # 7 | HaNoi | Vietnam | ||
180 | Investigational site # 8 | HaNoi | Vietnam | ||
181 | Investigational site # 9 | HaNoi | Vietnam | ||
182 | Investigational site | Ho Chi Minh | Vietnam | ||
183 | Investigational site | Hue | Vietnam |
Sponsors and Collaborators
- Arcus Biosciences, Inc.
Investigators
- Study Director: Medical Director, Arcus Biosciences, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ARC-10