A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer

Completed · Phase 1

Conditions studied: Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer, Nonsquamous Nonsmall Cell Neoplasm of Lung, Sensitizing EGFR Gene Mutation

In brief

This is a Phase 1/1b, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and clinical activity of etrumadenant (AB928) in combination with carboplatin and pemetrexed, with or without an anti-PD-1 antibody (pembrolizumab or zimberelimab), in participants with non-squamous Non-Small Cell Lung Cancer (NSCLC).

Key facts

Study ID

NCT03846310

Run by

Arcus Biosciences, Inc.

People needed

77

Starts

2019-04-01

Expected to finish

2024-11-18

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants; age ≥ 18 years
• 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

You may not qualify if…

• Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product
• 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

Where it is running

• 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, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan
• Tri Service General Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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