Lung CancerPhase 2VELOCITY-LungNCT05633667
Study of Novel Treatment Combinations in Patients With Lung Cancer
A Phase 2 study testing Zimberelimab (ZIM), Domvanalimab (DOM) and Sacituzumab govitecan-hziy (SG) in people with Lung Cancer and Advanced or Metastatic Non-Small-Cell Lung Cancer, run by Gilead Sciences at 89 sites in 8 countries.
Trial summary
The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Advanced or Metastatic Non-Small-Cell Lung Cancer, Resectable Non-Small-Cell Lung Cancer
- What is being tested?
- Zimberelimab (ZIM), Domvanalimab (DOM) and Sacituzumab govitecan-hziy (SG)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 89 sitesin 8 countries
- Study dates
- 16 Mar 2023to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All Substudies:
- Histologically or cytologically documented non-small-cell lung cancer (NSCLC).
- No known actionable genomic alterations for which targeted therapies are available.
- Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.
- Measurable disease per response evaluation criteria in solid tumors.
- Adequate hematologic and end-organ function.
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- Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.
- Substudy 01: All Experimental arms
- Stage IV NSCLC.
- For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.
- PD-L1 status by central confirmation.
- No prior systemic treatment for metastatic NSCLC.
- Substudy 02: All Experimental arms
- Stage IV NSCLC.
- In individuals with nonsquamous histology and actionable EGFR, ALK, or other known genomic alterations must have received treatment with at least 1 targeted therapy to the appropriate genomic alteration.
- Substudy 03: All Experimental arms
- Previously untreated individuals with resectable (Stage II, IIIA, IIIB (T[3-4]N2) NSCLC (per American Joint Committee on Cancer (AJCC) Edition 8).
- Planned surgery must comprise of lobectomy, sleeve lobectomy, or bi-lobectomy.
- PD-L1 status by central confirmation.
- For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.
Who cannot join
- All Substudies:
- Mixed small-cell lung cancer and NSCLC histology.
- Active second malignancy.
- Active autoimmune disease.
- History of or current non-infectious pneumonitis/interstitial lung disease.
- Active serious infection within 4 weeks prior to study treatment.
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- Substudy 01 and 02
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Received previous anticancer therapy within 4 weeks prior to enrollment.
- Substudy 03: All Experimental arms
- NSCLC previously treated with systemic therapy or radiotherapy.
- Received prior treatment with any anti-PD-(L)-1 or other immune checkpoint inhibitors (CPIs).
- Note: Other protocol defined inclusion/exclusion criteria may apply
Trial locations and contacts
89 sites in 8 countries.
89 sites in 8 countries
South Korea23 sites
Chungbuk National University Hospital,Substudy-01
Cheongju-si, 28644
Chungbuk National University Hospital,Substudy-02
Cheongju-si, 28644
National Cancer Center,Substudy-01
Goyang, 410769
National Cancer Center,Substudy-02
Goyang, 410769
National Cancer Center,Substudy-03
Goyang, 410769
Chonnam National University Hwasun Hospital,Substudy-01
Gwangju, 61469
Chonnam National University Hwasun Hospital,Substudy-03
Gwangju, 61469
Seoul National University Bundang Hospital,Substudy-01
Gyeonggi-do, 463-707
Seoul National University Bundang Hospital,Substudy-03
Gyeonggi-do, 463-707
Kosin University Gospel Hospital,Substudy-01
Seogu, 49267
Kosin University Gospel Hospital,Substudy-03
Seogu, 49267
Severance Hospital, Yonsei University Health System,Substudy-03
Seoul, 03722
Asan Medical Center,Substudy-02
Seoul, 05505
Asan Medical Center,Substudy-03
Seoul, 05505
Asan Medical Centre,Substudy-01
Seoul, 05505
Samsung Medical Center,Substudy-01
Seoul, 06351
Samsung Medical Center,Substudy-02
Seoul, 06351
Samsung Medical Center,Substudy-03
Seoul, 06351
Severance Hospital, Yonsei University Health System,Substudy-01
Seoul, 120-752
Severance Hospital, Yonsei University Health System,Substudy-02
Seoul, 120-752
Seoul National University,Substudy-02
Seoul, 463-707
Korea University Guro Hospital,Substudy-01
Seoul, 8308
Korea University Guro Hospital,Substudy-03
Seoul, 8308
United States11 sites
Oncology Hematology Care Clinical Trials, LLC,Substudy-01
Cincinnati, Ohio, 45242
Oncology Hematology Care Clinical Trials, LLC,Substudy-02
Cincinnati, Ohio, 45242
Oncology Associates of Oregon, PC,Substudy-01
Eugene, Oregon, 97401
Oncology Associates of Oregon, PC,Substudy-02
Eugene, Oregon, 97401
Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
Fort Wayne, Indiana, 46845
Baptist Health Lexington,Substudy-03
Lexington, Kentucky, 40503
Washington University School of Medicine - Siteman Cancer Center,Substudy-01
St Louis, Missouri, 63110
Washington University School of Medicine - Siteman Cancer Center,Substudy-02
St Louis, Missouri, 63110
Washington University School of Medicine - Siteman Cancer Center,Substudy-03
St Louis, Missouri, 63110
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
Arizona Oncology Associates,Substudy-02
Tucson, Arizona, 85711
Israel11 sites
Rambam Health Care Campus,Substudy-01
Haifa, 3525408
Rambam Health Care Campus,Substudy-02
Haifa, 3525408
Rambam Health Care Campus,Substudy-03
Haifa, 3525408
Shaare Zedek Medical Center,Substudy-01
Jerusalem, 9103102
Shaare Zedek Medical Center,Substudy-02
Jerusalem, 9103102
Shaare Zedek Medical Center,Substudy-03
Jerusalem, 9103102
Hadassah Medical Center,Substudy-01
Jerusalem, 91120
Hadassah University Medical Center,Substudy-03
Jerusalem, 91120
Tel Aviv Sourasky Medical Center,Substudy-01
Tel Aviv, 64239
Tel Aviv Sourasky Medical Center,Substudy-02
Tel Aviv, 64239
Tel-Aviv Sourasky Medical Center,Substudy-03
Tel Aviv, 64239
Taiwan11 sites
Changhua Christian Hospital,Substudy-01
Changhua, 500-06
Changhua Christian Hospital,Substudy-02
Changhua, 500-06
Changhua Christian Hospital,Substudy-03
Changhua, 500-06
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01
Kaohsiung City, 80756
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02
Kaohsiung City, 80756
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03
Kaohsiung City, 80756
Kaohsiung Chang Gung Memorial Hospital,Substudy-01
Kaohsiung City, 83301
Kaohsiung Chang Gung Memorial Hospital,Substudy-02
Kaohsiung City, 83301
Kaohsiung Chang Gung Memorial Hospital,Substudy-03
Kaohsiung City, 83301
National Taiwan University Hospital,Substudy-01
Taipei, 100
National Taiwan University Hospital,Substudy-02
Taipei, 100
Brazil10 sites
Fundação Pio XII - Hospital de Amor,Substudy-01
Barretos, 14784-400
Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03
Porto Alegre, 90110-270
Hospital Mae de Deus,Substudy-01
Porto Alegre, 90110-270
Hospital Mae de Deus
Porto Alegre, 90110-270
Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-01
Porto Alegre, 90610001
Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03
Porto Alegre, 90610001
BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01
São Paulo, 1509
Fundação Antonio Prudente - Hospital do Câncer AC Camargo,Substudy-01
São Paulo, 1509
Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03
São Paulo, 1509
Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03
São Paulo, 1509
Turkey (Türkiye)10 sites
Adana City Training and Research Hospital,Substudy-01
Adana, 01120
Memorial Ankara Hastanesi,Substudy-01
Ankara, 06520
Memorial Ankara Hospital,Substudy-03
Ankara, 06520
Medical Park Samsun,Substudy-01
Atakum, 55200
Dicle University,Substudy-01
Diyarbakır, 21100
Dicle University Medical Faculty,Substudy-03
Diyarbakır, 21280
Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01
Konya, 42080
Necmettin Erbakan Universitesi,Substudy-03
Meram Konya, 42080
Gazi University Medical Faculty,Substudy-01
Yenimahalle
Gazi University Medical Faculty,Substudy-03
Yenimahalle
United Kingdom7 sites
Birmingham Heartlands Hospital,Substudy-03
Birmingham, B9 5SS
University Hospitals Birmingham NHS Trust,Substudy-01
Birmingham, B9 5SS
University Hospitals Birmingham NHS Trust,Substudy-02
Birmingham, B9 5SS
St James University Hospital,,Substudy-01
Leeds, LS9 7TF
St. Bartholomew's Hospital,Substudy-01
London, E1 1BB
St. Bartholomew's Hospital,Substudy-02
London, E1 1BB
St. Bartholomew's Hospital,Substudy-03
London, E1 1BB
Hong Kong6 sites
Queen Mary Hospital,Substudy-01
Hong Kong, 999077
Queen Mary Hospital,Substudy-02
Hong Kong, 999077
Queen Elizabeth Hospital,Substudy-01
Hong Kong
Queen Elizabeth Hospital,Substudy-02
Hong Kong
Prince of Wales Hospital,Substudy-01
New Territories
Prince of Wales Hospital,Substudy-02
New Territories
About this study
Official title: A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)
The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC.
The primary objectives of this study are:
Read more
Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.
- Conditions
- Lung Cancer, Advanced or Metastatic Non-Small-Cell Lung Cancer, Resectable Non-Small-Cell Lung Cancer
- Being tested
- Zimberelimab (ZIM), Domvanalimab (DOM), Sacituzumab govitecan-hziy (SG), Etrumadenant (ETRUMA), Carboplatin
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimberelimab (ZIM)Drug
Also called AB122, GS-0122
Administered intravenously
Domvanalimab (DOM)Drug
Also called AB154, GS-0154
Administered intravenously
Sacituzumab govitecan-hziy (SG)Drug
Also called GS-0132, IMMU-132
Administered intravenously
Etrumadenant (ETRUMA)Drug
Also called AB928, GS-0928
Administered orally
CarboplatinDrug
Administered intravenously
CisplatinDrug
Administered intravenously
PemetrexedDrug
Administered intravenously
PaclitaxelDrug
Administered intravenously
Nab-paclitaxelDrug
Administered intravenously
DocetaxelDrug
Administered intravenously
NivolumabDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM) | Experimental | Participants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met. Receives: Drug: Zimberelimab (ZIM); Drug: Domvanalimab (DOM); Drug: Sacituzumab govitecan-hziy (SG) |
| Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA) | Experimental | Participants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. Receives: Drug: Zimberelimab (ZIM); Drug: Domvanalimab (DOM); Drug: Etrumadenant (ETRUMA) |
| Substudy 01: ZIM + ETRUMA | Experimental | Participants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. Receives: Drug: Zimberelimab (ZIM); Drug: Etrumadenant (ETRUMA) |
| Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) | Experimental | Participants will receive ZIM and SG until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met. Receives: Drug: Zimberelimab (ZIM); Drug: Sacituzumab govitecan-hziy (SG) |
| Substudy 01: ZIM + Platinum Based Chemotherapy | Active comparator | Expansion Stage Only: Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology).
Platinum Based Chemotherapy will be cisplatin or carboplatin and pemetrexed (non-squamous histology) or carboplatin, paclitaxel and nabpaclitaxel (squamous histology). Receives: Drug: Zimberelimab (ZIM); Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel |
| Substudy 02: SG + ZIM + ETRUMA | Experimental | Participants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. Receives: Drug: Zimberelimab (ZIM); Drug: Sacituzumab govitecan-hziy (SG); Drug: Etrumadenant (ETRUMA) |
| Substudy 02: Either Docetaxel or SG (Monotherapy Only) | Active comparator | Participants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. Receives: Drug: Sacituzumab govitecan-hziy (SG); Drug: Docetaxel |
| Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy | Experimental | Participants will receive ZIM plus DOM and any one of the chemotherapy (choice of chemotherapy is dependent on histology).
Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology). Receives: Drug: Zimberelimab (ZIM); Drug: Domvanalimab (DOM); Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel |
| Substudy 03 - ZIM + Platinum-based Chemotherapy | Experimental | Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology).
Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology). Receives: Drug: Zimberelimab (ZIM); Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel |
| Substudy 03: Nivolumab + Platinum-based Chemotherapy | Active comparator | Participants will receive nivolumab plus any one of the chemotherapy (choice of chemotherapy is dependent on histology).
Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology). Receives: Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as confirmed at least 4 weeks after the first detection of response.
Measured: Up to 5 years
Substudy 03: Complete Pathological Response (pCR) Rate
pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes as assessed by local pathology review.
Measured: Up to 5 years
Secondary outcomes (7)
Substudies 01 and 02: Progression-free Survival (PFS) According to RECIST Version 1.1
PFS is defined as the time from the date of randomization until disease progression (PD) or death, whichever comes first.
Measured: Up to 5 years
Substudies 01 and 02: Duration of response (DOR) According to RECIST Version 1.1
DOR is defined as the time from the first response (CR or PR) until the first documented PD, or death, whichever comes first.
Measured: Up to 5 years
All Substudies: Overall survival (OS)
OS is defined as the time from the date of randomization until death from any cause.
Measured: Up to 5 years
Substudy 03: Event-Free Survival (EFS)
Event-Free Survival (EFS) is defined as the time from randomization until any of the following events: any progression precluding surgery or preventing completion of surgery, progression or recurrence of disease after surgery (local or distant), as assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death due to any cause, whichever occurs first. Participants who do not undergo surgery for reasons other than progression will be considered to have had an event at progression or at death.
Measured: Up to 5 years
Substudy 03: Major Pathological Response (MPR) Rate
MPR rate is defined as the percentage of participants with ≤ 10% residual tumor in lung and lymph nodes at surgery as evaluated by local pathology review.
Measured: Up to 5 years
All Substudies: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs
Measured: First dose date up to 24 months plus 100 days
All Substudies: Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Measured: First dose date up to 24 months plus 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start16 Mar 2023
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arcus Biosciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633667
- Sponsor's protocol ID
- GS-US-624-6376
- Other IDs
- MOH_2022-12-13_012231
- Acronym
- VELOCITY-Lung
- Status last verified
- May 2026
- First submitted
- 21 Nov 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)
- ClinicalTrials.gov ID
- NCT05633667
- Acronym / sponsor ID
- VELOCITY-Lung / GS-US-624-6376
- Conditions
- Lung Cancer, Advanced or Metastatic Non-Small-Cell Lung Cancer, Resectable Non-Small-Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Arcus Biosciences, Inc.
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 1 Dec 2022 (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.
The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC.
The primary objectives of this study are:
Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM) | Experimental | Drug: Zimberelimab (ZIM), Drug: Domvanalimab (DOM), Drug: Sacituzumab govitecan-hziy (SG)Participants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA) | Experimental | Drug: Zimberelimab (ZIM), Drug: Domvanalimab (DOM), Drug: Etrumadenant (ETRUMA)Participants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 01: ZIM + ETRUMA | Experimental | Drug: Zimberelimab (ZIM), Drug: Etrumadenant (ETRUMA)Participants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) | Experimental | Drug: Zimberelimab (ZIM), Drug: Sacituzumab govitecan-hziy (SG)Participants will receive ZIM and SG until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 01: ZIM + Platinum Based Chemotherapy | Active comparator | Drug: Zimberelimab (ZIM), Drug: Carboplatin, Drug: Cisplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxelExpansion Stage Only: Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be cisplatin or carboplatin and pemetrexed (non-squamous histology) or carboplatin, paclitaxel and nabpaclitaxel (squamous histology). |
| Substudy 02: SG + ZIM + ETRUMA | Experimental | Drug: Zimberelimab (ZIM), Drug: Sacituzumab govitecan-hziy (SG), Drug: Etrumadenant (ETRUMA)Participants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 02: Either Docetaxel or SG (Monotherapy Only) | Active comparator | Drug: Sacituzumab govitecan-hziy (SG), Drug: DocetaxelParticipants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
| Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy | Experimental | Drug: Zimberelimab (ZIM), Drug: Domvanalimab (DOM), Drug: Carboplatin, Drug: Pemetrexed, Drug: PaclitaxelParticipants will receive ZIM plus DOM and any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology). |
| Substudy 03 - ZIM + Platinum-based Chemotherapy | Experimental | Drug: Zimberelimab (ZIM), Drug: Carboplatin, Drug: Pemetrexed, Drug: PaclitaxelParticipants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology). |
| Substudy 03: Nivolumab + Platinum-based Chemotherapy | Active comparator | Drug: Carboplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: NivolumabParticipants will receive nivolumab plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically or cytologically documented non-small-cell lung cancer (NSCLC).
- No known actionable genomic alterations for which targeted therapies are available.
- Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.
- Measurable disease per response evaluation criteria in solid tumors.
- Adequate hematologic and end-organ function.
Key exclusion criteria (13 listed)
- Mixed small-cell lung cancer and NSCLC histology.
- Active second malignancy.
- Active autoimmune disease.
- History of or current non-infectious pneumonitis/interstitial lung disease.
- Active serious infection within 4 weeks prior to study treatment.
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 |
|---|---|---|
| Zimberelimab (ZIM)Also: AB122, GS-0122Administered intravenously | Drug | Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA), Substudy 01: ZIM + ETRUMA, Substudy 01: ZIM + Platinum Based Chemotherapy, Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG), Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM), Substudy 02: SG + ZIM + ETRUMA, Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy, Substudy 03 - ZIM + Platinum-based Chemotherapy |
| Domvanalimab (DOM)Also: AB154, GS-0154Administered intravenously | Drug | Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA), Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM), Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy |
| Sacituzumab govitecan-hziy (SG)Also: GS-0132, IMMU-132Administered intravenously | Drug | Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG), Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM), Substudy 02: Either Docetaxel or SG (Monotherapy Only), Substudy 02: SG + ZIM + ETRUMA |
| Etrumadenant (ETRUMA)Also: AB928, GS-0928Administered orally | Drug | Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA), Substudy 01: ZIM + ETRUMA, Substudy 02: SG + ZIM + ETRUMA |
| CarboplatinAdministered intravenously | Drug | Substudy 01: ZIM + Platinum Based Chemotherapy, Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy, Substudy 03 - ZIM + Platinum-based Chemotherapy, Substudy 03: Nivolumab + Platinum-based Chemotherapy |
| CisplatinAdministered intravenously | Drug | Substudy 01: ZIM + Platinum Based Chemotherapy |
| PemetrexedAdministered intravenously | Drug | Substudy 01: ZIM + Platinum Based Chemotherapy, Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy, Substudy 03 - ZIM + Platinum-based Chemotherapy, Substudy 03: Nivolumab + Platinum-based Chemotherapy |
| PaclitaxelAdministered intravenously | Drug | Substudy 01: ZIM + Platinum Based Chemotherapy, Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy, Substudy 03 - ZIM + Platinum-based Chemotherapy, Substudy 03: Nivolumab + Platinum-based Chemotherapy |
| Nab-paclitaxelAdministered intravenously | Drug | Substudy 01: ZIM + Platinum Based Chemotherapy |
| DocetaxelAdministered intravenously | Drug | Substudy 02: Either Docetaxel or SG (Monotherapy Only) |
| NivolumabAdministered intravenously | Drug | Substudy 03: Nivolumab + Platinum-based Chemotherapy |
Primary outcome
Substudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to 5 years
ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as confirmed at least 4 weeks after the first detection of response.
Substudy 03: Complete Pathological Response (pCR) Rate
Time frame: Up to 5 years
pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes as assessed by local pathology review.
7 secondary outcomes
Substudies 01 and 02: Progression-free Survival (PFS) According to RECIST Version 1.1
Time frame: Up to 5 years
Substudies 01 and 02: Duration of response (DOR) According to RECIST Version 1.1
Time frame: Up to 5 years
All Substudies: Overall survival (OS)
Time frame: Up to 5 years
Substudy 03: Event-Free Survival (EFS)
Time frame: Up to 5 years
Substudy 03: Major Pathological Response (MPR) Rate
Time frame: Up to 5 years
All Substudies: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs
Time frame: First dose date up to 24 months plus 100 days
All Substudies: Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose date up to 24 months plus 100 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Gilead Study Director study director
Gilead Sciences
89 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zimberelimab (ZIM), Domvanalimab (DOM) and Sacituzumab govitecan-hziy (SG) in people with Lung Cancer and Advanced or Metastatic Non-Small-Cell Lung Cancer, run by Gilead Sciences at 89 sites in 8 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 20 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in South Korea, United States, Israel, Taiwan, Brazil and 3 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?
This study is still under way. Results are not available in the source record yet.
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?
Substudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: Up to 5 years). The study lists 2 primary outcomes in all. 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 1 Jun 2026.