A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer
NCT ID: NCT03846310
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
77 participants
INTERVENTIONAL
2019-04-01
2024-11-18
Brief Summary
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Detailed Description
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In the dose-expansion phase, zimberelimab in combination with carboplatin and pemetrexed (Arm 1), and etrumadenant at RDE in combination with carboplatin, pemetrexed, and zimberelimab (Arm 2) may be assessed in eligible NSCLC participants who harbor an EGFR mutation and have progressed on EGFR Tyrosine Kinase Inhibitor (TKI) treatment(s).
Overall duration of treatment will depend on how well the treatment is tolerated.
Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Arm A
Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer.
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Carboplatin
Carboplatin administered as part of standard chemotherapy regimen
Pemetrexed
Pemetrexed administered as part of standard chemotherapy regimen
Dose Escalation Arm B
Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen and pembrolizumab in participants with Non-Small Cell Lung Cancer.
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Carboplatin
Carboplatin administered as part of standard chemotherapy regimen
Pemetrexed
Pemetrexed administered as part of standard chemotherapy regimen
Pembrolizumab
Pembrolizumab is a humanized anti-PD-1 monoclonal antibody
Dose Expansion Arm 1
Zimberelimab will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation.
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Carboplatin
Carboplatin administered as part of standard chemotherapy regimen
Pemetrexed
Pemetrexed administered as part of standard chemotherapy regimen
Dose Expansion Arm 2
The etrumadenant at RDE determined from the dose escalation phase will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen and zimberelimab in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation.
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Carboplatin
Carboplatin administered as part of standard chemotherapy regimen
Pemetrexed
Pemetrexed administered as part of standard chemotherapy regimen
Interventions
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Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Carboplatin
Carboplatin administered as part of standard chemotherapy regimen
Pemetrexed
Pemetrexed administered as part of standard chemotherapy regimen
Pembrolizumab
Pembrolizumab is a humanized anti-PD-1 monoclonal antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed nonsquamous NSCLC that is metastatic, locally advanced, or recurrent with progression
* Arm A participants must fulfill one of the following:
* Participant has a genetic alteration (mutation or rearrangement) and has received all available targeted therapy. Previous treatment with chemotherapy or PD-1/-L1 therapy is not allowed.
* Participant has not received any therapy for the disease under study and standard therapy is refused.
* Participant has progressed on PD-1/-L1 therapy (monotherapy or combination regimen). Previous treatment with chemotherapy is not allowed.
* Participant has progressed on PD-1/-L1 therapy (monotherapy or combination regimen) and has received less than 4 cycles of carboplatin/pemetrexed and further chemotherapy is appropriate.
* Participant has received any number of prior treatments and is without alternative or curative therapy.
* Arm B participants must fulfill one of the following:
* Participant has a genetic alteration (mutation or rearrangement) and has received all available targeted therapy. Previous treatment with chemotherapy or PD-1/-L1 therapy is not allowed.
* Participant has not received any therapy for the disease under study and standard therapy is refused.
* Participant has received any number of prior treatments and is without alternative or curative therapy.
* Arm 1 and Arm 2 participants must have a sensitizing epidermal growth factor receptor (EGFR) mutation with disease progression or treatment intolerance after one or more approved TKIs. Previous treatment with chemotherapy or PD-1/L-1 therapy is not allowed.
* No TKI therapy within 5 days of Cycle 1 Day 1
* The last dose of previous investigational therapy is at least 4 weeks or 5 half-lives prior to Cycle 1 Day 1.
* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Confirm that an archival tissue sample is available and ≤ 24 months old; if not, a new biopsy of a tumor lesion should be obtained at screening
* Adequate organ and marrow function
Exclusion Criteria
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of etrumadenant, 90 days after the last dose of zimberelimab or pembrolizumab, or 6 months after the last dose of pemetrexed, whichever is longer
* 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 use of an adenosine pathway targeting agent
* Due to potential for drug-drug interactions with etrumadenant, participants must not have had:
* Treatment with breast cancer resistance protein substrates or P-glycoprotein with a narrow therapeutic window, administered orally within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment.
* Treatment with known strong cytochrome P450 3A4 (CYP3A4) inducers and strong CYP3A4 inhibitors within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences, Inc.
Locations
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Arizona Cancer Research Center (ACRC)
Tucson, Arizona, United States
SCRI Florida Cancer Specialists - South
Fort Myers, Florida, United States
SCRI Florida Cancer Specialists - North
Tavares, Florida, United States
SCRI Tennessee Oncology - Nashville
Nashville, Tennessee, United States
USO Texas Oncology - Dallas (Baylor Charles A. Sammons Cancer Center)
Dallas, Texas, United States
USO Virginia Cancer Specialist
Fairfax, Virginia, United States
USO Virginia Oncology Associates
Norfolk, Virginia, United States
Medical Oncology Associates/Summit Cancer Center
Spokane, Washington, United States
National University Hospital
Singapore, , Singapore
National Cancer Centre Singapore
Singapore, , Singapore
The Catholic University of Korea St. Vincent Hospital
Suwon, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Bundang CHA Medical Center
Seongnam-si, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Centre
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Seoul National University Hospital
Suwon, , South Korea
Changhua Christian Hospital
Changhua, , Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, , Taiwan
Chi Mei Hospital, Liouying
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Tri Service General Hospital
Taipei, , Taiwan
Countries
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Related Links
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ARC-4 - Public website
Other Identifiers
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ARC-4 (AB928CSP0004)
Identifier Type: -
Identifier Source: org_study_id