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Dose Tapering and Early Discontinuation to InCreAse cosT-effectIveness Of Immunotherapy for NSCLC

NCT04909684 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2024-04-11

No results posted yet for this study

Summary

Rationale: Immune checkpoint inhibitors have shown to improve the overall survival for patients with metastasized non-small cell lung carcinoma (NSCLC) but the optimal dosing and patient selection are still a matter of discussion. The pembrolizumab dose, for instance, may be reduced significantly without decreasing treatment efficacy. Furthermore, as approximately only half of all patients responds to treatment, there is an urgent need to develop (early) treatment response prediction markers to select those who benefit from treatment.

Objective: Primary: to investigate the non-inferiority of pembrolizumab 75% versus pembrolizumab 100% in terms of overall survival. Secondary: to develop biomarkers that predict immunotherapy treatment response.

Study design: An open label randomized non-inferiority study.

Study population: 750 patients with NSCLC, eligible for treatment with pembrolizumab, in line with the current ESMO clinical practice guidelines.

Intervention: Patients will be randomized to standard of care (100%) versus reduced dose (approx. 75%, depending on treatment schedule) pembrolizumab.

Main study parameters/endpoints: One-year overall survival rate

Conditions

Interventions

DRUG

Pembrolizumab

The approved doses of 400 mg every 6 weeks (Q6W) and 200 mg every 3 weeks (Q3W) will be decreased to a 300 mg Q6W dose. The approved dose of 150 mg Q3W will be decreased to a 100 mg Q3W dose.

Sponsors & Collaborators

  • Dutch Society of Physicians for Pulmonology and Tuberculosis

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Michel vd Heuvel, prof. · Head of Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909684 on ClinicalTrials.gov