Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer

Summary

This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, 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 . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.

Conditions

• Resectable Lung Non-Small Cell Carcinoma
• Stage II Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8

Interventions

PROCEDURE

Surgical Procedure

undergo surgery

DRUG

Cisplatin

Give cisplatin

DRUG

Carboplatin

Give Carboplatin

DRUG

Pemetrexed

Give Pemetrexed

DRUG

Gemcitabine

Give Gemcitabine

DRUG

Docetaxel

Give Docetaxel

DRUG

Vinorelbine

Give Vinorelbine

DRUG

Nivolumab

Give Nivolumab

DRUG

Pembrolizumab

Give Pembrolizumab

DRUG

Atezolizumab

Give Atezolizumab

PROCEDURE

Computed Tomography

Undergo CT and/or PET/CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• Daniel Morgensztern, MD · Alliance for Clinical Trials in Oncology

• Raid Aljumaily, MD · Alliance for Clinical Trials in Oncology

• Linda Martin, MD · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-11

Primary Completion

2029-04-30

Completion

2030-04-30

Countries

• United States

Study Locations