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NCT07845786Not yet recruitingPhase 2

Zanzalintinib and Pembrolizumab in First-Line Maintenance for Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

A Phase 2, Single-Arm, Multicenter Trial of Zanzalintinib in Combination With Pembrolizumab in First-Line Maintenance for Metastatic Squamous Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 29 Sept 2026

Brief summary (registry, in English)

The primary purpose of the study is to evaluate the effectiveness of zanzalintinib in combination with pembrolizumab as first-line maintenance therapy in participants with metastatic squamous NSCLC.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
22 Sept 2026
Start date
15 Dec 2026
Primary completion date
15 Jun 2028
Lead sponsor
Exelixis
Diseases
Lung cancer
NCT number
NCT07845786

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 15 Dec 2026 to the primary completion date, 15 Jun 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Targetable genomic aberrations for which approved targeted therapy is available.
  • Active autoimmune disease or a history of autoimmune disease within 2 years prior to the first dose of induction therapy requiring systemic immunosuppressive therapy.
    • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Other illness

  • Tumor invasion, encasement of organs, or major blood vessels, if poses a significant increased risk of bleeding.
  • The participant has uncontrolled, significant intercurrent or recent illness.

Other

  • Nonsquamous histology NSCLC.

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of ≥ 6 months.
  • Stage IV squamous NSCLC as defined by American Joint Committee on Cancer (AJCC) 9th Edition.
  • Measurable disease according to RECIST v1.1 as determined by the investigator and documented prior to starting induction therapy.
  • Programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) \< 50% as assessed per local testing. To minimize assay variability, local laboratory must ascertain PD-L1 status using the PD-L1 Immunohistochemistry (IHC) 22C3 pharmDx assay.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.