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

ConditionSquamous Non-Small Cell Lung Cancer (NSCLC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorExelixis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Carboplatin

    Drug

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

  • Paclitaxel

    Drug

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

  • Nab-paclitaxel

    Drug

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

  • Pembrolizumab

    Drug

    Administered as specified in the treatment arm.

  • Zanzalintinib

    Drug

    Administered as specified in the treatment arm.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Zanzalintinib + PembrolizumabExperimental treatment 5 interventions

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

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

Time frame
Up to 30 months
2

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

Time frame
Up to 30 months
3

PFS per RECIST v1.1 as assessed by Investigator

Time frame
Up to 30 months
4

Overall Survival (OS)

Time frame
Up to 30 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Exelixis

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: