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Study of Pembrolizumab With Single Agent Chemotherapy in Elderly Patients With Advanced NSCLC

NCT04754815 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-03-29

No results posted yet for this study

Summary

This Phase II trial is to see how well single agent chemotherapy and pembrolizumab work elderly patients (≥ 75 years) with advanced non small cell lung cancer (NSCLC). Pembrolizumab stimulates your immune system to help fight lung cancer. This treatment approach may be better tolerated in elderly patients.

Conditions

  • Non Small Cell Lung Cancer
  • Advanced Lung Non-Small Cell Carcinoma
  • PD-L1 Gene Mutation

Interventions

DRUG

Pembrolizumab

PD-L1 inhibitor administered as an intravenous (IV) infusion.

DRUG

Pemetrexed

Folate analog metabolic inhibitor administered as an intravenous (IV) infusion single agent chemotherapy for advanced NSCLC

DRUG

Paclitaxel

A novel antimicrotubular agent administered as an intravenous (IV) infusion single agent chemotherapy for advanced NSCLC

DRUG

Nab-paclitaxel

Microtubule inhibitor administered as an intravenous (IV) infusion indicated for the treatment of locally advanced or metastatic NSCLC

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

Principal Investigators

  • Shirish Gadgeel, MBBS · Henry Ford Health System

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2025-04-01
Completion
2026-04-01
FDA Drug
Yes

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Entities

Drugs
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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 NCT04754815 on ClinicalTrials.gov