Double immunotherapy attack shows promise for tough lung cancer

NCT ID NCT04736173

Disease control Sponsor: Arcus Biosciences, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 5 times

Summary

This phase 2 trial is testing a combination of two immunotherapy drugs, zimberelimab and domvanalimab, as a first treatment for people with advanced non-small cell lung cancer that has high levels of a protein called PD-L1. The study includes 169 participants and aims to see if the combination helps keep the cancer from growing longer than standard treatments. Researchers are also checking overall survival, tumor shrinkage, and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Zimberelimab and domvanalimab (two immunotherapy drugs)
What this could lead to: If successful, this combination could offer a new first-line treatment option for people with advanced lung cancer that has high PD-L1 levels, potentially improving how long they live without their cancer worsening.
What could go wrong: This is a mid-stage trial with only 169 participants, so results may not apply to everyone. Immunotherapy can cause serious side effects like inflammation in healthy organs, and the combination may not work better than existing treatments.

Why investors are watching

Arcus Biosciences is running a phase 2 trial testing its drug zimberelimab combined with domvanalimab in 169 patients with a type of lung cancer called PD-L1-high non-small cell lung cancer. For a small company like Arcus, this readout matters because the combination is a key part of its pipeline, and a clear result could shape its future value and partnerships.

If it works: If the combination shows strong disease control in this patient group, Arcus could gain credibility for its drugs and attract larger partners to help fund later-stage development. A positive result may also strengthen the company's position in the competitive lung cancer treatment field.

If it fails: Phase 2 trials often fail to meet their goals, and a disappointing result could hurt Arcus's reputation and make it harder to secure funding or partnerships. A delay in the readout could also strain the company's resources, given its small size.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

169 people

The number who actually took part.

Started

Feb 2021

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm non-small cell lung carcinoma non-small cell squamous lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung cancer Non-small cell lung cancer Nonsquamous non small cell lung cancer Squamous non-small cell lung cancer

Contacts and locations

Locations

Research Site

Columbus, Georgia, 31904, United States
Research Site

Kingwood, Texas, 77339, United States
Research Site

Blacksburg, Virginia, 24060, United States
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Hong Kong, Hong Kong
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Johor Bahru, Malaysia
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Kuala Lumpur, Malaysia
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Kuantan, Malaysia
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Kuching, Malaysia
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Pulau Pinang, Malaysia
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Putrajaya, Malaysia
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Davao City, Philippines
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Manila, Philippines
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George, South Africa
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Johannesburg, South Africa
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Pretoria, South Africa
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Daegu, South Korea
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Incheon, South Korea
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Jinju, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Taichung, Taiwan
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Bangkok, Thailand
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Changwat Sara Buri, Thailand
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Chanthaburi, Thailand
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Chiang Mai, Thailand
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Khon Kaen, Thailand
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Lampang, Thailand
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Nakhon Nayok, Thailand
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Nakhon Ratchasima, Thailand
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Phitsanulok, Thailand
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Songkhla, Thailand
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Ubon Ratchathani, Thailand
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Edirne, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Hanoi, Vietnam
Research Site

Huế, Vietnam

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