Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in P… (NCT06173505) | Clinical Trial Compass
TerminatedPhase 1/2
Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC
Stopped: Business Decision
United States, Belgium, Greece28 participantsStarted 2023-12-27
Plain-language 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 nonsquamous non-small cell lung cancer (NSCLC).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 thes…
What they're measuring
1
Part 1: Recommended Phase 2 dose of vudalimab in combination with chemotherapy