NCT07845786

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
43mo left

Started Dec 2026

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

December 15, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2028

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2030

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Squamous Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (5)

  • Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator

    Up to 30 months

  • Duration of Response (DOR) per RECIST v1.1 as assessed by Investigator

    Up to 30 months

  • PFS per RECIST v1.1 as assessed by Investigator

    Up to 30 months

  • Overall Survival (OS)

    Up to 30 months

  • Number of Participants With Adverse Events (AEs)

    Up to 30 months

Study Arms (1)

Zanzalintinib + Pembrolizumab

EXPERIMENTAL

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.

Drug: CarboplatinDrug: PaclitaxelDrug: Nab-paclitaxelDrug: PembrolizumabDrug: Zanzalintinib

Interventions

CarboplatinDRUG

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

Zanzalintinib + Pembrolizumab
PaclitaxelDRUG

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

Zanzalintinib + Pembrolizumab
Nab-paclitaxelDRUG

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

Zanzalintinib + Pembrolizumab
PembrolizumabDRUG

Administered as specified in the treatment arm.

Zanzalintinib + Pembrolizumab
ZanzalintinibDRUG

Administered as specified in the treatment arm.

Zanzalintinib + Pembrolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

CarboplatinPaclitaxel130-nm albumin-bound paclitaxelpembrolizumab

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Medical Director

    Exelixis

    STUDY DIRECTOR

Central Study Contacts

Exelixis Clinical Trials

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 29, 2026

Study Start (Estimated)

December 15, 2026

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 15, 2030

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share