Clinical trial NCT04736173: Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer
Official title: Official Title: A Phase 2 Study to Evaluate Zimberelimab (AB122) Combined With AB154 in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Nonsquamous Non Small Cell Lung Cancer
Squamous Non Small Cell Lung Cancer
Lung Cancer
Keywords: Domvanalimab
Zimberelimab
Non Small Cell Lung Cancer
Lung Cancer
NSCLC
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2021-02-03
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) in front-line, PD-L1-high, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC).


Eligibility criteria: Key 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:

  1. Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose.
  2. 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.
  3. Carcinomatous meningitis is excluded regardless of clinical stability.

Key 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From randomization until death from any cause (up to 7 years)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization until death from any cause (up to 7 years)
measure: Confirmed Overall Response Rate (ORR)
timeFrame: From randomization until death from any cause (up to 7 years)
measure: Number of Participants With treatment-emergent adverse events
timeFrame: From randomization until death from any cause (up to 7 years)
Other outcomes:
Locations:
city: Hinsdale
country: United States
facility: Hope and Healing Cancer Service
state: Illinois
city: Athens
country: Greece
facility: General hospital of Athens, chest diseases Sotiria
city: Chaidari
country: Greece
facility: University General Hospital "Attikon"
city: Kifissia
country: Greece
facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"
city: Patras
country: Greece
facility: General Hospital of Patra Agios Andreas
city: Hong Kong
country: Hong Kong
facility: Hong Kong Integrated Oncology Centre
city: Hong Kong
country: Hong Kong
facility: Hong Kong United Oncology Centre
city: Hong Kong
country: Hong Kong
facility: Humanity and Health Clinical Trial Centre
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St. Mary's Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Cha University Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Eunpyeong St. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital.
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Centre
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
city: Pulau Pinang
country: Malaysia
facility: Mount Miriam Cancer Hospital
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara
city: Benito Juarez
country: Mexico
facility: Health Pharma Professional Research
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
city: Cebu
country: Philippines
facility: Chong Hua Hospital
city: Davao City
country: Philippines
facility: Metro Davao Medical and Research Centre
city: Manila
country: Philippines
facility: Makati Medical Centre
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Quezon City
country: Philippines
facility: St. Luke Medical Centre Quezon City
city: George
country: South Africa
facility: Exellentis Clinical Trial Consultants
city: Johannesburg
country: South Africa
facility: Cancercare PE
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
city: Johannesburg
country: South Africa
facility: Wits Clinical Research CMJAH Clinical Trial Site
city: Port Elizabeth
country: South Africa
facility: Port Elizabeth Oncology Centre-Cancercare
city: Pretoria
country: South Africa
facility: University of Pretoria Medical Oncology
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Police General Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Bangkok
country: Thailand
facility: Vajira Hospital
city: Chanthaburi
country: Thailand
facility: Prapokklao Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Chiang Mai
country: Thailand
facility: Nakornping Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Lampang
country: Thailand
facility: Lampang Hospital
city: Nakhon Nayok
country: Thailand
facility: HRH Princess Maha Chakri Sirindhorn Medical Centre
city: Nakhon Ratchasima
country: Thailand
facility: Maharat Nakhon Ratchasima Hospital
city: Phitsanulok
country: Thailand
facility: Buddhachinaraj Phitsanulok Hospital
city: Phitsanulok
country: Thailand
facility: Naresuan University Hospital
city: Saraburi
country: Thailand
facility: Saraburi Hospital
city: Songkhla
country: Thailand
facility: Songkhlanagarind Hospital
city: Ubon Ratchathani
country: Thailand
facility: Sunpasitthiprasing Hospital
city: Udon Thani
country: Thailand
facility: Udon Thani Hospital
city: Adana
country: Turkey
facility: Adana City Hospital
city: Adana
country: Turkey
facility: Ankara City Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Memorial Ankara Hospital
city: Cankaya
country: Turkey
facility: Gazi University Medical Faculty
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Atakent Hospital
city: Istanbul
country: Turkey
facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital
city: Istanbul
country: Turkey
facility: Medipol University Medical Facility
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitiesi Tip Fakultesi
city: Sur
country: Turkey
facility: Dicle University, Medical faculty
city: Hanoi
country: Vietnam
facility: 103 Military Hospital
city: Hanoi
country: Vietnam
facility: National Lung Hospital
city: Hue
country: Vietnam
facility: Hue Central Hospital
Study officials:
affiliation: Arcus Biosciences, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: