Non Small Cell Lung CancerPhase 2ARC-10NCT04736173
Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer
A Phase 2 study testing Domvanalimab, Zimberelimab and Carboplatin in people with Non Small Cell Lung Cancer and Nonsquamous Non Small Cell Lung Cancer, run by Arcus Biosciences, Inc. at 38 sites in 10 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer
- What is being tested?
- Domvanalimab, Zimberelimab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 38 sitesin 10 countries
- Study dates
- 8 Feb 2021to 17 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose.
- 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.
- Carcinomatous meningitis is excluded regardless of clinical stability.
Who cannot join
- 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.
Trial locations and contacts
38 sites in 10 countries.
38 sites in 10 countries
Thailand11 sites
Research Site
Bangkok
Research Site
Changwat Sara Buri
Research Site
Chanthaburi
Research Site
Chiang Mai
Research Site
Khon Kaen
Research Site
Lampang
Research Site
Nakhon Nayok
Research Site
Nakhon Ratchasima
Research Site
Phitsanulok
Research Site
Songkhla
Research Site
Ubon Ratchathani
Malaysia6 sites
Research Site
Johor Bahru
Research Site
Kuala Lumpur
Research Site
Kuantan
Research Site
Kuching
Research Site
Pulau Pinang
Research Site
Putrajaya
South Korea5 sites
Research Site
Daegu
Research Site
Incheon
Research Site
Jinju
Research Site
Seoul
Research Site
Suwon
Turkey (Türkiye)5 sites
Research Site
Adana
Research Site
Ankara
Research Site
Edirne
Research Site
Istanbul
Research Site
Kocaeli
United States3 sites
Research Site
Blacksburg, Virginia, 24060
Research Site
Columbus, Georgia, 31904
Research Site
Kingwood, Texas, 77339
South Africa3 sites
Research Site
George
Research Site
Johannesburg
Research Site
Pretoria
About this study
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
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).
- Conditions
- Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer, Lung Cancer
- Being tested
- Domvanalimab, Zimberelimab, Carboplatin, Paclitaxel, Pemetrexed
- Keywords
- Domvanalimab, Zimberelimab, Non Small Cell Lung Cancer, Lung Cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomvanalimabDrug
Also called AB154
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
ZimberelimabDrug
Also called AB122
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
CarboplatinDrug
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
PaclitaxelDrug
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
PemetrexedDrug
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
PembrolizumabDrug
Pembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Study Part 1 (Platinum-based Chemotherapy) | Active comparator | Participants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion. Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed |
| Arm B - Study Part 1 (Zimberelimab Monotherapy) | Experimental | Participants will receive zimberelimab monotherapy by IV infusion. Receives: Drug: Zimberelimab |
| Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy) | Experimental | Participants will receive zimberelimab in combination with AB154 by IV infusion. Receives: Drug: Domvanalimab; Drug: Zimberelimab |
| Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy) | Experimental | Participants will receive domvanalimab in combination with zimberelimab by IV infusion. Receives: Drug: Domvanalimab; Drug: Zimberelimab |
| Arm E - Study Part 2 (Pembrolizumab) | Active comparator | Participants will receive pembrolizumab by IV infusion. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Measured: From randomization until death from any cause (up to 7 years)
Secondary outcomes (3)
Overall Survival (OS)
Measured: From randomization until death from any cause (up to 7 years)
Confirmed Overall Response Rate (ORR)
Measured: From randomization until death from any cause (up to 7 years)
Number of Participants With treatment-emergent adverse events
Measured: From randomization until death from any cause (up to 7 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start8 Feb 2021
- Primary completion17 Sep 2026
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736173
- Sponsor's protocol ID
- ARC-10
- Other IDs
- 2020-003562-39, PHRR210222-003371, 2022-503071-28-00
- Acronym
- ARC-10
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04736173
- Acronym / sponsor ID
- ARC-10 / ARC-10
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 17 Sep 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A - Study Part 1 (Platinum-based Chemotherapy) | Active comparator | Drug: Carboplatin, Drug: Paclitaxel, Drug: PemetrexedParticipants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion. |
| Arm B - Study Part 1 (Zimberelimab Monotherapy) | Experimental | Drug: ZimberelimabParticipants will receive zimberelimab monotherapy by IV infusion. |
| Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy) | Experimental | Drug: Domvanalimab, Drug: ZimberelimabParticipants will receive zimberelimab in combination with AB154 by IV infusion. |
| Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy) | Experimental | Drug: Domvanalimab, Drug: ZimberelimabParticipants will receive domvanalimab in combination with zimberelimab by IV infusion. |
| Arm E - Study Part 2 (Pembrolizumab) | Active comparator | Drug: PembrolizumabParticipants will receive pembrolizumab by IV infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DomvanalimabAlso: AB154Domvanalimab is a humanized monoclonal antibody targeting human TIGIT | Drug | Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy), Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy) |
| ZimberelimabAlso: AB122Zimberelimab is a fully human anti-PD-1 monoclonal antibody | Drug | Arm B - Study Part 1 (Zimberelimab Monotherapy), Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy), Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy) |
| CarboplatinParticipants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve. | Drug | Arm A - Study Part 1 (Platinum-based Chemotherapy) |
| PaclitaxelParticipants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve. | Drug | Arm A - Study Part 1 (Platinum-based Chemotherapy) |
| PemetrexedParticipants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve. | Drug | Arm A - Study Part 1 (Platinum-based Chemotherapy) |
| PembrolizumabPembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor | Drug | Arm E - Study Part 2 (Pembrolizumab) |
Primary outcome
Progression-free Survival (PFS)
Time frame: From randomization until death from any cause (up to 7 years)
3 secondary outcomes
Overall Survival (OS)
Time frame: From randomization until death from any cause (up to 7 years)
Confirmed Overall Response Rate (ORR)
Time frame: From randomization until death from any cause (up to 7 years)
Number of Participants With treatment-emergent adverse events
Time frame: From randomization until death from any cause (up to 7 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- ARC-10 - Public WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Arcus Biosciences, Inc.
38 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Domvanalimab, Zimberelimab and Carboplatin in people with Non Small Cell Lung Cancer and Nonsquamous Non Small Cell Lung Cancer, run by Arcus Biosciences, Inc. at 38 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Thailand, Malaysia, South Korea, Turkey (Türkiye), United States and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: From randomization until death from any cause (up to 7 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.