Immunotherapy + Chemotherapy for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of immunotherapy (cemiplimab) and chemotherapy to determine if it extends the lives of people with advanced non-small cell lung cancer (NSCLC). The researchers aim to discover whether this treatment surpasses standard chemotherapy, particularly in individuals whose tumors exhibit specific levels of a protein called PD-L1. Suitable candidates for this trial include those with advanced lung cancer who have not received prior treatment and have a measurable tumor. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on corticosteroid therapy at a dose greater than 10 mg of prednisone per day, you may need to stop or adjust it before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that cemiplimab, often used with chemotherapy, is generally safe for treating advanced non-small cell lung cancer (NSCLC). Studies have found that when used alone, cemiplimab causes serious side effects like lung inflammation in only about 2.6% of patients, indicating it is usually well-tolerated.
When combined with chemotherapy, cemiplimab maintains a consistent safety profile. One study found serious treatment-related side effects in 18.3% of patients using cemiplimab with chemotherapy, compared to 39.9% for those using chemotherapy alone. This suggests that cemiplimab does not significantly increase the risk of severe side effects.
In summary, cemiplimab, whether used alone or with chemotherapy, is generally safe for NSCLC patients, with studies reporting manageable side effects.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for non-small cell lung cancer, which typically involves chemotherapy alone, the treatments in this trial incorporate cemiplimab, a type of immunotherapy. Cemiplimab works by targeting and blocking the PD-1 pathway, allowing the immune system to better attack cancer cells. Researchers are excited about this approach because it has the potential to enhance the effectiveness of chemotherapy, possibly leading to improved outcomes for patients. Additionally, combining cemiplimab with chemotherapy or an abbreviated form of chemotherapy plus ipilimumab (another immune checkpoint inhibitor) offers multiple pathways to potentially boost the immune system's response to cancer.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Studies have shown that cemiplimab, especially when combined with chemotherapy, greatly improves survival rates in patients with advanced non-small cell lung cancer (NSCLC). In this trial, some participants will receive cemiplimab with chemotherapy, which research indicates more than doubles the chance of living for five years compared to chemotherapy alone. Patients receiving this combination also experience longer periods before their cancer worsens, known as improved progression-free survival (PFS). This combination has demonstrated lasting improvements in survival, offering hope for those with NSCLC. Overall, cemiplimab plus chemotherapy provides a clear survival benefit for people battling this type of lung cancer.14678
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) who haven't had systemic treatment for metastatic or recurrent disease. Participants must have a performance status indicating they can care for themselves and an expected lifespan of at least 3 months. They should not be candidates for chemoradiation, have measurable lesions, and specifically in Part 1, less than 50% PD-L1 tumor expression.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive combinations of cemiplimab and platinum-based doublet chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cemiplimab
- Chemotherapy
- Placebo
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Sanofi
Industry Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University