Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer

Summary

This phase I/II trial tests the safety and efficacy of split-course adaptive radiation therapy in combination with immunotherapy with or without chemotherapy for the treatment of patients with stage IV lung cancer or lung cancer that that has spread to nearby tissue or lymph nodes (locally advanced). Radiation therapy is a standard cancer treatment that uses high energy rays to kill cancer cells and shrink tumors. Split-course adaptive radiation therapy uses patient disease response to alter the intensity of the radiation therapy. Immunotherapy with monoclonal antibodies such as pembrolizumab, ipilimumab, cemiplimab, atezolizumab or nivolumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs like carboplatin, pemetrexed, and paclitaxel work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving split-course adaptive radiation therapy with standard treatments like immunotherapy and chemotherapy may be more effective at treating stage IV or locally advanced lung cancer than giving them alone.

Conditions

• Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8
• Stage III Lung Cancer

Interventions

PROCEDURE

Biospecimen Collection

Correlative studies

DRUG

Carboplatin

Given carboplatin

PROCEDURE

Computed Tomography

Undergo PET/CT

OTHER

Fludeoxyglucose F-18

Given IV

DRUG

Nab-paclitaxel

Given nab-paclitaxel

BIOLOGICAL

Pembrolizumab

Given pembrolizumab

DRUG

Pemetrexed

Given pemetrexed

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

RADIATION

Radiation Therapy

Undergo radiation therapy

OTHER

[18-F] (fluoropropyl)-L-glutamate (FSPG) PET scan

Undergo PET scan

BIOLOGICAL

Ipilimumab

Given Ipilimumab

BIOLOGICAL

Nivolumab

Given Nivolumab

BIOLOGICAL

Cemiplimab

Given Cemiplimab

BIOLOGICAL

Atezolizumab

Given Atezolizumab

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Varian Medical Systems

  collaborator INDUSTRY

• Vanderbilt-Ingram Cancer Center

  lead OTHER

Principal Investigators

• Evan Osmundson, MD, PhD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-09

Primary Completion

2026-02-01

Completion

2027-02-01

FDA Device

Yes

Countries

• United States

Study Locations