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Closed (no longer recruiting)Last updated: 9 January 2024

ARC-7: This phase II trial is evaluating the safety and effectiveness of a new immunotherapy (zimberelimab) alone and in combination with other types of immunotherapy in patients with advanced non-small cell lung cancerA Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer

Clinical summary

Summary

Eligible patients will be randomised to 1 of 3 treatment arms: (1) zimberelimab, (2) zimberelimab + AB154 (anti-TIGIT antibody), or (3) zimberelimab + AB154 + AB928 (dual adenosine receptor antagonist). Patients that progress onzimberelimab monotherapy (treatment arm 1) may cross-over to receive combination of zimberelimab + AB154 + AB928 (in treatment arm 3).

Conditions

This trial is treating patients with non-small cell lung cancer.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

ARC-7

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Arcus Biosciences, Inc.

Scientific Title

A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer

Eligibility

Inclusion

  • Male or female participants; age ≥ 18 years
  • Histologically confirmed, treatment naïve, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
  • 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

  • Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs)
  • Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption)
  • History of trauma or major surgery within 28 days prior to the first dose of IMP
  • Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications
  • Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody with presence of Hepatitis C qualitative RNA or human immunodeficiency virus (HIV-1 and/or HIV-2) antibody at screening
  • 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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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