Treatment Timing for Non-Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer based on your specific situation.
What data supports the effectiveness of the drugs Atezolizumab, Nivolumab, and Pembrolizumab for treating non-small cell lung cancer?
What safety data exists for treatments like Atezolizumab, Nivolumab, and Pembrolizumab in humans?
Atezolizumab, Nivolumab, and Pembrolizumab have been studied for safety in patients with non-small cell lung cancer, showing they are generally safe but can cause immune-related side effects. These treatments are approved for use because they improve survival and quality of life compared to standard chemotherapy.45678
How is the drug treatment with Atezolizumab, Nivolumab, and Pembrolizumab different for non-small cell lung cancer?
Research Team
Daniel Morgensztern, MD
Principal Investigator
Alliance for Clinical Trials in Oncology
Raid Aljumaily, MD
Principal Investigator
Alliance for Clinical Trials in Oncology
Eligibility Criteria
This trial is for adults over 18 with stage II-IIIB resectable non-small cell lung cancer (NSCLC), who haven't had systemic treatment for NSCLC in the last 5 years. They should have a performance status indicating they can care for themselves and are up to light work. People with certain other cancers or treatments within the past 3 years, active autoimmune diseases, interstitial lung disease, transplants that conflict with immunotherapy, or untreated HIV are excluded.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Therapy
Patients receive platinum-based doublet chemotherapy and immune checkpoint inhibitor therapy before surgery
Surgery
Patients undergo surgery to remove the tumor
Adjuvant Therapy
Patients receive immune checkpoint inhibitor therapy for up to 1 year after surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atezolizumab
- Carboplatin
- Cisplatin
- Docetaxel
- Gemcitabine
- Nivolumab
- Pembrolizumab
- Pemetrexed
- Vinorelbine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator