Nonsquamous Non-small Cell Lung CancerPhase 1/2NCT06173505
Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC
A Phase 1/2 study testing Vudalimab + Carboplatin + Pemetrexed and Pembrolizumab + Carboplatin + Pemetrexed in people with Nonsquamous Non-small Cell Lung Cancer, run by Xencor, Inc. at 17 sites in 8 countries.
Trial summary
The purpose of this study is to identify the recommended dose of vudalimab to be used in combination with chemotherapy (Part 1) and to evaluate the efficacy and safety of vudalimab plus standard of care chemotherapy relative to pembrolizumab plus chemotherapy (Part 2) as first-line treatment in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsquamous Non-small Cell Lung Cancer
- What is being tested?
- Vudalimab + Carboplatin + Pemetrexed and Pembrolizumab + Carboplatin + Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 17 sitesin 8 countries
- Study dates
- 27 Dec 2023to 29 Dec 2025
- Phase
- Phase 1/2
- 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, locally advanced (unresectable) or metastatic nonsquamous NSCLC
- Documented absence of tumor activating EGFR mutation, ALK gene and ROS1 rearrangements, and alterations in any actionable driver oncogenes for which there are locally approved targeted first-line therapies
- PD-L1 IHC testing documenting TPS < 49%
- No prior systemic treatment for advanced/metastatic NSCLC.
- Measurable disease by RECIST 1.1
- ECOG performance status score of 0 or 1
- Life expectancy ≥ 3 months
- Adequate liver, kidney, thyroid and bone marrow function
Who cannot join
- Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable
- Active known or suspected autoimmune disease
- Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
- Interstitial lung disease that is symptomatic
- Known human immunodeficiency virus (HIV) positive with CD4+ T-cell (CD4+) count < 350 cells/μL, or an HIV viral load greater than 400 copies/mL, or a history of an acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, or not on established antiretroviral therapy (ART) for at least 4 weeks prior to initiation of study drug dosing. (HIV positive subjects who do not meet these exclusion criteria are eligible)
- Positive test for hepatitis C RNA (a patient who is hepatitis C virus [HCV] antibody positive but HCV RNA negative due to documented, curative prior antiviral treatment or natural resolution is eligible)
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- Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb) (a patient whose hBsAg is negative and hBcAb is positive may be enrolled if a hepatitis B virus (HBV) DNA test is negative and the subject is retested for HbsAg and HBV DNA every 2 months)
- History or evidence of any clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than NSCLC, that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study evaluations, procedures, or completion
- Other protocol defined inclusion/exclusion criteria apply.
Trial locations and contacts
17 sites in 8 countries.
17 sites in 8 countries
Spain5 sites
NEXT Oncology-Hospital Quirónsalud Barcelona
Barcelona, 08023
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Institut Català d'Oncolgia de Girona
Girona, 17007
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
United States3 sites
Hematology Associates of Fredericksburg
Fredericksburg, Virginia, 22408
Palo Verde Cancer Specialists
Glendale, Arizona, 85304
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360
Malaysia3 sites
Hospital Sultan Ismail
Johor Bahru, 81100
Hospital Umum Sarawak
Kuching, 93586
Institut Kanser Negara
Putrajaya, 62250
Taiwan2 sites
Changhua Christian Hospital
Changhua, 500
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Netherlands1 site
The Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, North Holland, 1066 CX
Portugal1 site
ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira Guimarães
Guimarães, 4835-044
About this study
Official title: A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer
The purpose of this study is to identify the recommended dose of vudalimab to be used in combination with chemotherapy (Part 1) and to evaluate the efficacy and safety of vudalimab plus standard of care chemotherapy relative to pembrolizumab plus chemotherapy (Part 2) as first-line treatment in patients with nonsquamous non-small cell lung cancer (NSCLC).
Read the detailed description
This is a Phase 1b/2 study, multicenter, open-label, randomized study in patients with nonsquamous non-small cell lung cancer without prior treatment for metastatic disease. Part 1 is designed to identify the recommended Phase 2 dose (RP2D) of vudalimab, an anti-PD-1/CTLA-4 bispecific antibody, in combination with standard of care (SOC) chemotherapy. Part 2 will evaluate the efficacy and safety vudalimab, at the RP2D, plus SOC relative to pembrolizumab (anti-PD-1) plus SOC chemotherapy.
- Conditions
- Nonsquamous Non-small Cell Lung Cancer
- Being tested
- Vudalimab + Carboplatin + Pemetrexed, Pembrolizumab + Carboplatin + Pemetrexed
- Keywords
- Non-small cell lung cancer, Nonsquamous, XmAb20717, vudalimab, anti-PD-1 x anti-CTLA-4, checkpoint inhibitor, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vudalimab + Carboplatin + PemetrexedCombination product
Vudalimab intravenous + carboplatin intravenous + pemetrexed intravenous
Pembrolizumab + Carboplatin + PemetrexedCombination product
Pembrolizumab intravenous + carboplatin intravenous + pemetrexed intravenous
| Study group | Role | What they receive |
|---|---|---|
| Vudalimab + Carboplatin + Pemetrexed | Experimental | Not described Receives: Combination Product: Vudalimab + Carboplatin + Pemetrexed |
| Pembrolizumab + Carboplatin + Pemetrexed | Active comparator | Not described Receives: Combination Product: Pembrolizumab + Carboplatin + Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Recommended Phase 2 dose of vudalimab in combination with chemotherapy
Incidence of treatment-emergent adverse events and treatment-related adverse events leading to discontinuation of treatment
Measured: Day 1 to Day 21
Part 2: Progression free survival
Progressive disease per RECIST 1.1 or death, whichever comes first
Measured: Day 1 to 2.5 years
Secondary outcomes (7)
Antitumor activity
Objective response rate as determined by investigator, duration of response (Part 1 and Part 2)
Measured: Day 1 to 1.4 years
Changes in circulating tumor DNA (ctDNA)
Examine ctDNA changes as a surrogate marker for disease burden (Part 1 and Part 2)
Measured: Day 1 to 1.4 years
Maximum Serum Drug Concentration (Cmax)
(Part 1 and Part 2)
Measured: Day 1 to 1.4 years
Trough Serum Drug Concentration (Ctrough)
(Part 1 and Part 2)
Measured: Day 1 to 1.4 years
Area Under the Concentration-time Curve (AUC)
(Part 1 and Part 2)
Measured: Day 1 to 1.4 years
Overall survival
Time to death from any cause (Part 2)
Measured: Day 1 to 2.5 years
Incidence of treatment-emergent adverse events
Measured: Time Frame: Day 1 to 1.4 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start27 Dec 2023
- Primary completion24 Dec 2025
- Study completion29 Dec 2025
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsquamous 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jolene Shorr, Study director, Executive Director, Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173505
- Sponsor's protocol ID
- XmAb717-06
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06173505
- Acronym / sponsor ID
- XmAb717-06
- Conditions
- Nonsquamous Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Nonsquamous, XmAb20717, vudalimab, anti-PD-1 x anti-CTLA-4, checkpoint inhibitor, chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 15 Dec 2023 (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 purpose of this study is to identify the recommended dose of vudalimab to be used in combination with chemotherapy (Part 1) and to evaluate the efficacy and safety of vudalimab plus standard of care chemotherapy relative to pembrolizumab plus chemotherapy (Part 2) as first-line treatment in patients with nonsquamous non-small cell lung cancer (NSCLC).
Detailed description
This is a Phase 1b/2 study, multicenter, open-label, randomized study in patients with nonsquamous non-small cell lung cancer without prior treatment for metastatic disease. Part 1 is designed to identify the recommended Phase 2 dose (RP2D) of vudalimab, an anti-PD-1/CTLA-4 bispecific antibody, in combination with standard of care (SOC) chemotherapy. Part 2 will evaluate the efficacy and safety vudalimab, at the RP2D, plus SOC relative to pembrolizumab (anti-PD-1) plus SOC chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vudalimab + Carboplatin + Pemetrexed | Experimental | Combination Product: Vudalimab + Carboplatin + Pemetrexed |
| Pembrolizumab + Carboplatin + Pemetrexed | Active comparator | Combination Product: Pembrolizumab + Carboplatin + Pemetrexed |
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, locally advanced (unresectable) or metastatic nonsquamous NSCLC
- Documented absence of tumor activating EGFR mutation, ALK gene and ROS1 rearrangements, and alterations in any actionable driver oncogenes for which there are locally approved targeted first-line therapies
- PD-L1 IHC testing documenting TPS < 49%
- No prior systemic treatment for advanced/metastatic NSCLC.
- Measurable disease by RECIST 1.1
Key exclusion criteria (9 listed)
- Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable
- Active known or suspected autoimmune disease
- Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
- Interstitial lung disease that is symptomatic
- Known human immunodeficiency virus (HIV) positive with CD4+ T-cell (CD4+) count < 350 cells/μL, or an HIV viral load greater than 400 copies/mL, or a history of an acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, or not on established antiretroviral therapy (ART) for at least 4 weeks prior to initiation of study drug dosing. (HIV positive subjects who do not meet these exclusion criteria are eligible)
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 |
|---|---|---|
| Vudalimab + Carboplatin + PemetrexedVudalimab intravenous + carboplatin intravenous + pemetrexed intravenous | Combination product | Vudalimab + Carboplatin + Pemetrexed |
| Pembrolizumab + Carboplatin + PemetrexedPembrolizumab intravenous + carboplatin intravenous + pemetrexed intravenous | Combination product | Pembrolizumab + Carboplatin + Pemetrexed |
Primary outcome
Part 1: Recommended Phase 2 dose of vudalimab in combination with chemotherapy
Time frame: Day 1 to Day 21
Incidence of treatment-emergent adverse events and treatment-related adverse events leading to discontinuation of treatment
Part 2: Progression free survival
Time frame: Day 1 to 2.5 years
Progressive disease per RECIST 1.1 or death, whichever comes first
7 secondary outcomes
Antitumor activity
Time frame: Day 1 to 1.4 years
Changes in circulating tumor DNA (ctDNA)
Time frame: Day 1 to 1.4 years
Maximum Serum Drug Concentration (Cmax)
Time frame: Day 1 to 1.4 years
Trough Serum Drug Concentration (Ctrough)
Time frame: Day 1 to 1.4 years
Area Under the Concentration-time Curve (AUC)
Time frame: Day 1 to 1.4 years
Overall survival
Time frame: Day 1 to 2.5 years
Incidence of treatment-emergent adverse events
Time frame: Time Frame: Day 1 to 1.4 years]
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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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.
Jolene Shorr study director
Executive Director, Clinical Development
17 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vudalimab + Carboplatin + Pemetrexed and Pembrolizumab + Carboplatin + Pemetrexed in people with Nonsquamous Non-small Cell Lung Cancer, run by Xencor, Inc. at 17 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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain, United States, Malaysia, Taiwan, Belgium 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Business Decision). Results are not available in the source record.
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?
Part 1: Recommended Phase 2 dose of vudalimab in combination with chemotherapy (time frame: Day 1 to Day 21). 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 13 Mar 2026.