Treatment Timing for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+17 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Alliance for Clinical Trials in Oncology
Disqualifiers: Egfr, Alk alterations, Autoimmune, others
Stay on Your Current Meds
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
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?
Research shows that the drugs atezolizumab, nivolumab, and pembrolizumab, which are types of immunotherapy, have been effective in treating advanced non-small cell lung cancer, helping patients live longer and improving their overall outcomes.
12345What 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.
45678How is the drug treatment with Atezolizumab, Nivolumab, and Pembrolizumab different for non-small cell lung cancer?
This drug treatment is unique because it uses immunotherapy, which helps the body's immune system fight cancer by targeting specific proteins (PD-1/PD-L1) on cancer cells, potentially leading to longer-term survival compared to traditional chemotherapy.
3591011Eligibility 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
My lung cancer is at stage IIA to IIIB and can be removed with surgery.
I haven't had systemic treatment for NSCLC in the last 5 years, except for early-stage cancer treated to cure.
I am 18 years old or older.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Neoadjuvant Therapy
Patients receive platinum-based doublet chemotherapy and immune checkpoint inhibitor therapy before surgery
Up to 4 cycles
Multiple visits for chemotherapy administration
Surgery
Patients undergo surgery to remove the tumor
Within 28 days of registration
1 visit (in-person)
Adjuvant Therapy
Patients receive immune checkpoint inhibitor therapy for up to 1 year after surgery
Up to 1 year
Regular visits for therapy administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
Every 6 months for up to 10 years
Biannual visits (in-person)
Participant Groups
The study compares standard post-surgery therapy to therapy given both before and after surgery in patients with resectable NSCLC. It includes chemotherapy drugs like cisplatin and docetaxel, which kill or stop tumor growth; pemetrexed and gemcitabine that block DNA creation; vinorelbine that prevents cells from spreading; plus immunotherapies like nivolumab, pembrolizumab, atezolizumab which boost the immune system's attack on tumors.
2Treatment groups
Experimental Treatment
Group I: Arm 2 (neoadjuvant therapy, surgery, adjuvant therapy)Experimental Treatment13 Interventions
NEOADJUVANT THERAPY: Within 28 days of registration, patients receive platinum-based doublet chemotherapy (cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and/or vinorelbine) for up to 4 cycles in combination with immune checkpoint inhibitor (nivolumab, pembrolizumab, and/or atezolizumab) according to current approved guidelines.
SURGERY: Patients undergo surgery.
ADJUVANT THERAPY: Patients receive immune checkpoint inhibitor therapy (nivolumab, pembrolizumab, and/or atezolizumab) for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines.
Patients also undergo CT throughout the study and may undergo MRI and/or PET/CT at screening.
Group II: Arm 1 (surgery, adjuvant therapy)Experimental Treatment13 Interventions
SURGERY: Patients undergo surgery within 28 days of registration.
ADJUVANT THERAPY: Patients receive platinum-based doublet chemotherapy (cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and/or vinorelbine) for up to 4 cycles and immune checkpoint inhibitor therapy (nivolumab, pembrolizumab, and/or atezolizumab) for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines.
Patients also undergo CT throughout the study and may undergo MRI and/or PET/CT at screening.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Beebe Medical CenterLewes, DE
Beebe South Coastal Health CampusMillville, DE
Helen F Graham Cancer CenterNewark, DE
Medical Oncology Hematology Consultants PANewark, DE
More Trial Locations
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Who Is Running the Clinical Trial?
Alliance for Clinical Trials in OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Comparative efficacy and safety of immunotherapies targeting the PD-1/PD-L1 pathway for previously treated advanced non-small cell lung cancer: A Bayesian network meta-analysis. [2019]Two PD-1 (pembrolizumab, nivolumab) and one PD-L1(atezolizumab) inhibitors are approved for previously treated advanced non-small cell lung cancer but have not been compared in head-to-head trials.
Indirect comparison between pembrolizumab and nivolumab for the treatment of non-small cell lung cancer: A meta-analysis of randomized clinical trials. [2018]The purpose of this study is to evaluate the efficacy and adverse effects of nivolumab and pembrolizumab for the treatment of advanced non-small-cell lung cancer (NSCLC) by meta-analysis.
Comparative Efficacy of Second- and Subsequent-line Treatments for Metastatic NSCLC: A Fractional Polynomials Network Meta-analysis of Cancer Immunotherapies. [2020]Extended onset of treatment effect and longer-term survival with anti-programmed death-ligand 1 (PD-L1)/programmed cell death protein 1 (PD-1) immunotherapies, atezolizumab, nivolumab, and pembrolizumab, have changed the landscape of second- or subsequent-line (2L+) treatments for adults with non-small-cell lung cancer (NSCLC). This systematic literature review included phase I to IV randomized, controlled trials of 2L+ NSCLC therapies from MEDLINE, Embase, and secondary sources.
Effectiveness and safety of atezolizumab, nivolumab and pembrolizumab in metastatic non-small cell lung cancer. [2021]To determine the effectiveness and safety of atezolizumab, nivolumab and pembrolizumab in patients with non-small cell lung cancer.
The efficacy of anti-PD-1/PD-L1 therapy and its comparison with EGFR-TKIs for advanced non-small-cell lung cancer. [2021]To better understand the efficacy and safety of anti-PD-1/PD-L1 therapy (atezolizumab, pembrolizumab, nivolumab) in patients with previously treated advanced non-small-cell lung cancer (NSCLC).
Efficacy of Nivolumab and Pembrolizumab in Patients With Advanced Non-Small-Cell Lung Cancer Needing Treatment Interruption Because of Adverse Events: A Retrospective Multicenter Analysis. [2019]The programmed death 1 antibodies (PD-1 Ab) nivolumab and pembrolizumab improve overall survival (OS) in advanced non-small-cell lung cancer (NSCLC). We evaluated the correlation between immune-related adverse events (irAE) and treatment interruption due to irAE on clinical efficacy of PD-1 Ab in advanced NSCLC.
Immune checkpoint blockade for advanced non-small cell lung cancer: challenging clinical scenarios. [2023]Immune checkpoint blockade has shown anti-tumour activity and improved survival in advanced non-small cell lung cancer (NSCLC). A number of anti-PD-1/PD-L1 and CTLA-4 monoclonal antibody agents have been evaluated in metastatic non-small cell lung cancer. Nivolumab, pembrolizumab and atezolizumab are currently approved for use in clinical practice due to demonstrated improvement in response rate, overall survival (OS) and quality of life (QoL) over standard chemotherapy. We present a series of cases that highlight the clinical challenges that these novel agents present. A review of rare immune-related adverse events (AEs), optimal treatment duration and patient selection will be presented. This series will also address real-life clinical scenarios such as treatment re-challenge and management of immune-related AEs.
Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. [2022]We aimed to characterize the safety profile of pembrolizumab in advanced melanoma patients at our center to better reflect 'real-world' data on anti-PD-1 inhibitors.
Retreatment With Anti-PD-L1 Antibody in Advanced Non-small Cell Lung Cancer Previously Treated With Anti-PD-1 Antibodies. [2019]To evaluate the efficacy and safety of re-treatment with anti-programmed death (PD)-L1 antibody (atezolizumab) after anti-PD-1 antibody (nivolumab/pembrolizumab) treatment in advanced non-small cell lung cancer (NSCLC) patients.
Time-dependent population PK models of single-agent atezolizumab in patients with cancer. [2021]The time-varying clearance (CL) of the PD-L1 inhibitor atezolizumab was assessed on a population of 1519 cancer patients (primarily with non-small-cell lung cancer or metastatic urothelial carcinoma) from three clinical studies.
Clinical Efficacy and Safety Analysis of PD-1/PD-L1 Inhibitor vs. Chemotherapy in the Treatment of Advanced Non-Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis. [2023]To systematically evaluate the efficacy and safety of pembrolizumab (PD-1/PD-L inhibitor) and adjuvant chemotherapy to treat NSCLC and provide evidence-based reference for clinical use.