OncRef

Clinical Trial: NCT04533451

Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Alliance for Clinical Trials in Oncology
Information Provided By:Alliance for Clinical Trials in Oncology
Last Update Posted:2026-10-08

Study Overview

Brief Summary

This study evaluates the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back after a period of improvement (recurrent) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.

Official Title

Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated With First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)

Conditions

Metastatic Lung Adenocarcinoma, Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Adenocarcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

Intervention / Treatment

  • Drug: Pembrolizumab
  • Drug: Pemetrexed
  • Drug: Carboplatin
  • Other: Comprehensive Geriatric Assessment
  • Other: Questionnaire Administration
  • Other: Quality-of-Life Assessment

Other Study ID Numbers

  • A171901
  • NCI-2020-00544
  • UG1CA189823

Start Date (Actual)

2020-11-16

Primary Completion Date (Actual)

2023-10-31

Study Completion Date (Estimated)

2027-05-31

Enrollment (Actual)

101

Study Type

Interventional

Phase

Phase 2