Clinical trial · Interventional
Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Decision
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nonsquamous Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab + Carboplatin + Pemetrexed | Combination Product | — | UNRESOLVED |
| Vudalimab + Carboplatin + Pemetrexed | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vudalimab + Carboplatin + Pemetrexed
- interventionNames
- Combination Product: Vudalimab + Carboplatin + Pemetrexed
- type
- ACTIVE_COMPARATOR
- label
- Pembrolizumab + Carboplatin + Pemetrexed
- interventionNames
- Combination Product: Pembrolizumab + Carboplatin + Pemetrexed
Primary outcomes (2)
- measure
- Part 1: Recommended Phase 2 dose of vudalimab in combination with chemotherapy
- timeFrame
- Day 1 to Day 21
- description
- Incidence of treatment-emergent adverse events and treatment-related adverse events leading to discontinuation of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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) * 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.
References
Publications (0)
Data not yet available