Fianlimab + Cemiplimab for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+79 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Regeneron Pharmaceuticals
Must not be taking: Corticosteroids, Immunosuppressants
Disqualifiers: Never smoked, Brain metastases, EGFR mutations, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug combination for patients with advanced lung cancer. It aims to see if using two drugs together is more effective than one alone. The study also looks at side effects, how the drugs are processed in the body, and their impact on quality of life.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on corticosteroid therapy or have received certain systemic therapies recently, you may need to adjust or stop those medications before enrolling.
What data supports the effectiveness of the drug combination Fianlimab + Cemiplimab for Non-Small Cell Lung Cancer?
Research shows that cemiplimab, when used alone, helps patients with advanced non-small cell lung cancer live longer compared to standard chemotherapy, especially in those with high levels of a protein called PD-L1. This suggests that cemiplimab is effective in treating this type of lung cancer.12345
What is known about the safety of Fianlimab + Cemiplimab for Non-Small Cell Lung Cancer?
Cemiplimab, used in combination with other treatments, has been studied for safety in various cancers, including non-small cell lung cancer and cutaneous squamous cell carcinoma. Common side effects noted in trials include immune-related reactions, which are typical for this type of immunotherapy.13678
What makes the drug Fianlimab + Cemiplimab unique for treating non-small cell lung cancer?
The combination of Fianlimab and Cemiplimab is unique because Cemiplimab is a PD-1 inhibitor that enhances the immune system's ability to fight cancer by blocking T-cell inactivation, and it has shown significant survival benefits in patients with high PD-L1 expression in non-small cell lung cancer.13689
Eligibility Criteria
Adults with advanced non-small cell lung cancer (NSCLC) who haven't had prior treatments for metastatic disease, have high PD-L1 levels (≥50%), and can provide a tumor tissue sample. They should have at least one measurable lesion, good organ function, and an ECOG performance status of ≤1. Excluded are those needing significant steroid treatment recently, with certain immune conditions or untreated brain metastases.Inclusion Criteria
My organs and bone marrow are working well.
I can provide a tumor tissue sample that has not been treated since its collection.
I am fully active and can carry on all pre-disease activities without restriction.
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Exclusion Criteria
I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.
I haven't taken high-dose steroids for immune suppression in the last 14 days.
I do not have an active autoimmune disease that needed strong medication in the last 2 years.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the combination of fianlimab and cemiplimab or cemiplimab monotherapy
Up to 136 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 5 years
Treatment Details
Interventions
- Cemiplimab (Monoclonal Antibodies)
- Fianlimab (Monoclonal Antibodies)
- Placebo (Monoclonal Antibodies)
Trial OverviewThe trial is testing the effectiveness of fianlimab combined with cemiplimab versus cemiplimab alone in treating NSCLC. It will also examine side effects, drug levels in blood over time, potential antibody development against the drugs, and impacts on quality of life.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: C: cemiplimab monotherapy+placeboExperimental Treatment2 Interventions
Phase 2 and Phase 3
Group II: B: fianlimab+cemiplimabExperimental Treatment2 Interventions
Phase 2: fianlimab (LD) Phase 3: fianlimab (chosen dose)
Group III: A: fianlimab+cemiplimabExperimental Treatment2 Interventions
Phase 2: fianlimab (HD) Phase 3: fianlimab (chosen dose)
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
🇪🇺 Approved in European Union as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
🇺🇸 Approved in United States as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
🇨🇦 Approved in Canada as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
🇧🇷 Approved in Brazil as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tallahassee Memorial HealthcareTallahassee, FL
Arizona Clinical Research CenterTucson, AZ
Pinellas Hematology and OncologySaint Petersburg, FL
British Columbia Cancer Center- KelownaKelowna, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Regeneron PharmaceuticalsLead Sponsor
References
Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. [2022]We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line treatment of advanced non-small-cell lung cancer with programmed cell death ligand 1 (PD-L1) of at least 50%.
Patient-reported outcomes with cemiplimab monotherapy for first-line treatment of advanced non-small cell lung cancer with PD-L1 of ≥50%: The EMPOWER-Lung 1 study. [2023]In the EMPOWER-Lung 1 trial (ClinicalTrials.gov, NCT03088540), cemiplimab conferred longer survival than platinum-doublet chemotherapy for advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%. Patient-reported outcomes were evaluated among trial participants.
Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. [2023]In metastatic non-small cell lung cancer (NSCLC), tumors that do not harbor driver mutations in EGFR or gene fusions in ALK and ROS, PD-1 and PD-L1 inhibitors have become a cornerstone in first line treatment, either as monotherapy or in combination with chemotherapy. This paper reviews cemiplimab-rwlc, the third PD-1/L1 inhibitor to be approved in the setting for first line treatment in NSCLC, as monotherapy or in combination therapy with chemotherapy, to provide a perspective on the subtle differences in patient population for the cemiplimab studies and consideration of its primary and subgroup results in the context of first line therapies for NSCLC.
A Changing of the Guard: Immune Checkpoint Inhibitors With and Without Chemotherapy as First Line Treatment for Metastatic Non-small Cell Lung Cancer. [2023]Inhibitory antibodies targeting programmed death protein 1 (PD-1) and programmed death ligand 1 (PD-L1) have resulted in improved outcomes for many patients with metastatic non-small cell lung cancer in (NSCLC) in the second-line setting due to their ability to lead to prolonged anti-tumor immune responses. Combining these immunotherapies with platinum-based chemotherapy as first-line treatment has resulted in improved response rates and increased survival when compared to platinum-based chemotherapy alone. Certain patient populations may even benefit from immune checkpoint inhibitors as monotherapy in the first-line setting. The PD-1 inhibitor pembrolizumab is approved as monotherapy or in combination with platinum + pemetrexed for most newly diagnosed patients with metastatic NSCLC, excluding those with a targetable oncogene such as ALK and EGFR. The PD-L1 inhibitor atezolizumab is also approved in combination with bevacizumab + carboplatin + paclitaxel for the same population, with some parts of the world also approving this regimen for patients with ALK rearrangements or EGFR activating mutations. However, there are many other chemo-immunotherapy regimens that have been evaluated as initial treatment in metastatic NSCLC. Additionally, combinations of PD-1 axis inhibitors with cytotoxic T lymphocyte antigen-4 inhibitors have been examined, although none are yet approved. Here we review the clinical data in support of the current first-line approaches across histologies and biomarker subtypes, as well as highlight future research directions revealed by the current data.
Cost-Effectiveness of Cemiplimab Versus Standard of Care in the United States for First-Line Treatment of Advanced Non-small Cell Lung Cancer With Programmed Death-Ligand 1 Expression ≥50. [2022]This study aimed to evaluate the cost-effectiveness, from a US commercial payer perspective, of cemiplimab versus other first-line treatments for advanced non-small cell lung cancer with programmed death-ligand 1 expression ≥50%.
Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]Introduction: In September of 2018, the United States Federal Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for advanced cutaneous squamous cell carcinoma (CSCC). Cemiplimab is an intravenous human monoclonal antibody directed against programmed cell death-1 receptor (PD-1). Cemiplimab blocks T-cell inactivation and enhances the immune system's anti-tumor response. Areas Covered: We review CSCC and the studies leading to cemiplimab's approval, including common side effects and safety issues experienced during the clinical trials. Expert Opinion: Immunotherapy, specifically checkpoint inhibitors, represents an increasingly utilized class of medications that is proving to be an effective treatment option for those with certain cancers. Over time, immunotherapy is likely to be the standard of care for immune-sensitive tumors. There are many challenges that the field faces, including the identification of reliable biomarkers to better predict response, decreasing toxicity, and the potential treatment of organ transplant patients.
PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer. [2021]To characterize the safety, tolerability, and anti-tumor activity of cemiplimab as monotherapy or in combination with hypofractionated radiation therapy (hfRT) in patients with recurrent or metastatic cervical cancer. To determine the association between histology and programmed death-ligand 1 (PD-L1) expression.
Network meta-analysis of immune-oncology monotherapy as first-line treatment for advanced non-small-cell lung cancer in patients with PD-L1 expression ⩾50. [2022]Label="Background" NlmCategory="UNASSIGNED">For patients with advanced non-small-cell lung cancer (NSCLC) and high (⩾50%) programmed cell death-ligand 1 (PD-L1) expression, effective first-line immune-oncology monotherapies with significant survival benefits are approved, cemiplimab being the most recent. In a phase III trial, cemiplimab demonstrated significantly improved overall survival (OS) and progression-free survival (PFS) versus chemotherapy in patients with advanced NSCLC and PD-L1 ⩾50%. A systematic literature review and network meta-analysis (NMA) was conducted to identify/compare the efficacy/safety of cemiplimab versus pembrolizumab or other immune-oncology monotherapies from randomized-controlled trials (RCTs) published in November 2010-2020.
PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement. [2023]There are currently three first-line immunotherapy options used as monotherapy in advanced non-small cell lung cancer (NSCLC) patients with high programmed death ligand 1 (PD-L1) expression (≥50%). This manuscript aims to evaluate the available data on atezolizumab (AT), cemiplimab (CEMI), and pembrolizumab (PEMBRO) and to study the results obtained during pivotal trials, especially regarding patient subgroups.