Recruiting
Phase 2

Zanzalintinib & Pembrolizumab

Sponsor:

Exelixis

Code:

NCT07845786

Conditions

Squamous Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carboplatin

Paclitaxel

Nab-paclitaxel

Pembrolizumab

Zanzalintinib

Study Details

Brief summary:

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.

Conditions

Squamous Non-Small Cell Lung Cancer (NSCLC)

Study ID

NCT07845786

Start date

Dec 15, 2026

Status verified date

Nov, 2026

Completion date

Jun 15, 2030

Anticipated

Primary completion date

Jun 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • Nonsquamous histology NSCLC.
  • Tumor invasion, encasement of organs, or major blood vessels, if poses a significant increased risk of bleeding.
  • Targetable genomic aberrations for which approved targeted therapy is available.
  • The participant has uncontrolled, significant intercurrent or recent illness.
  • 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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zanzalintinib + Pembrolizumab

Participants will receive 4 cycles of once every 3 weeks (Q3W) induction therapy with pembrolizumab and standard of care (SOC) as prescribed by their treating physician.

Participants with complete response (CR), partial response (PR), or stable disease (SD) after induction therapy will begin treatment with zanzalintinib and pembrolizumab (maintenance therapy) via intravenous (IV) infusion Q3W.

Interventions

Carboplatin

Administered as part of SOC therapy as specified in the treatment arm.

Paclitaxel

Administered as part of SOC therapy as specified in the treatment arm.

Nab-paclitaxel

Administered as part of SOC therapy as specified in the treatment arm.

Pembrolizumab

Administered as specified in the treatment arm.

Zanzalintinib

Administered as specified in the treatment arm.

Primary outcome measure

  • Progression-Free Survival (PFS) at 6 Months (PFS-6) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by Investigator [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Exelixis Clinical Trials

1-888-393-5494druginfo@exelixis.com

Locations

Nebraska Cancer Specialists - Midwest Cancer Center - Legacy

Recruiting

Omaha, Nebraska, United States, 68130

More Information

Sponsor

Exelixis

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Exelixis on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.