Study to Evaluate Monotherapy Compared to Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer

Sponsor
Arcus Biosciences, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04736173
Collaborator
(none)
625
183
3
64.9
3.4
0.1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
625 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Study to Evaluate 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
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Jun 30, 2026

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:
  • AB122
  • 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:
  • AB122
  • Drug: Domvanalimab
    Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
    Other Names:
  • AB154
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [From randomization until death from any cause (up to approximately 7 years)]

      Arm A vs. Arm B

    2. 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

    3. Overall Survival (OS) [From randomization until death from any cause (up to approximately 7 years)]

      Arm B vs. Arm C

    Secondary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. PFS at Milestone Timepoints [6 months and 1 year]

      Arm A vs. Arm B - PFS as assessed by RECIST v1.1 by the investigator

    5. PFS at Milestone Timepoints [6 months and 1 year]

      Arm B vs. Arm C - PFS as assessed by RECIST v1.1 by the investigator

    6. Overall Survival at Milestone Timepoints [1 year, 2 years, and 3 years]

      Arm A vs. Arm B

    7. Overall Survival at Milestone Timepoints [1 year, 2 years, and 3 years]

      Arm B vs. Arm C

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Arcus Biosciences, Inc.
    ClinicalTrials.gov Identifier:
    NCT04736173
    Other Study ID Numbers:
    • ARC-10
    First Posted:
    Feb 3, 2021
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Arcus Biosciences, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2022