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Neoadjuvant Chemoradiation Plus Pembrolizumab Followed By Consolidation Pembrolizumab in NSCLC

NCT02987998 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-12-19

No results posted yet for this study

Summary

The purpose of this study is to determine the feasibility and evaluate the safety of delivering chemoradiotherapy, the usual approach to non-small cell lung cancer, in combination with pembrolizumab (MK-3745), followed by consolidation pembrolizumab after surgical resection. Consolidation therapy is treatment given following the initial treatment.

Pembrolizumab is an investigational drug (also known as Keytruda), which has been approved by the FDA for use in certain types of skin cancer (melanoma), and for use in certain types of head and neck cancer. However, it has not been approved for use in other cancers such as non-small cell lung cancer (NSCLC). Pembrolizumab is a monoclonal antibody that binds to the surface of some cells of the immune system and activates them against cancer cells. It is not chemotherapy.

Conditions

  • Stage IIIA Non-Small Cell Lung Cancer

Interventions

DRUG

Cisplatin

Cisplatin (50mg/m2 IV D1, 8, 29, 36)

DRUG

Etoposide

Etoposide (50mg/m2 IV D1-5, 29-33)

DRUG

Pembrolizumab

Pembrolizumab (200mg IV D1, 21, 42)

DRUG

Radiation

Radiation (1.8Gy/D to 45Gy in 25 fractions)

Sponsors & Collaborators

  • Nathan Pennell, MD, PhD

    lead OTHER

Principal Investigators

  • Nathan Pennell, MD, PhD · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-19
Primary Completion
2022-11-28
Completion
2022-11-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02987998 on ClinicalTrials.gov