NCT04754815

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

Phase II Study of Pemetrexed or Nab-paclitaxel With Pembrolizumab in Elderly (>/= 75 Years) Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shirish Gadgeel · Academic / Other
• Sex: All
• Age: 75 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective(s), Hypothesis(es), and Endpoint(s) I. Objective: To evaluate the efficacy of single agent chemotherapy and pembrolizumab in elderly (≥ 75 years) advanced NSCLC patients Hypothesis: We propose that single agent chemotherapy with pembrolizumab will be better tolerated and will provide similar efficacy as platinum-based combination chemotherapy with pembrolizumab in advanced elderly (≥75 years) NSCLC patients. Primary Endpoint: I. Assess median PFS in elderly (≥ 75 years) advanced NSCLC patients with tumor PD-L1 (\<50%) treated with pemetrexed or nab-paclitaxel and pembrolizumab. Secondary Objective(s), Hypothesis(es), and Endpoint(s) I. Objective: To assess additional measure of efficacy of the regimen. To define the toxicity of the regimen in addition II. Hypothesis: In this patient population single agent chemotherapy and pembrolizumab will provide similar efficacy but improved tolerability as 2 drug combination with pembrolizumab. Secondary Endpoints: I. Assess overall survival in the study population II. Assess the toxicities with the study therapy and the rate of discontinuation of study therapy due to toxicities related to study therapy Exploratory Objective: I. Objective: To define correlatives that can identify patients most likely to benefit from the study therapy. II. Correlate PFS with blood-based tumor mutational burden and ctDNA. Participants who experience confirmed disease progression or start a new anticancer therapy, will move into the Survival Follow-Up Phase and should be contacted by telephone every 12 weeks to assess for survival status until death, withdrawal of consent, or the end of the trial, whichever occurs first.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-01
• Primary completion: 2025-04-01
• Completion: 2026-04-01
• First posted: 2021-02-15
• Last updated: 2022-03-29

Regulatory

• FDA-regulated drug study