Fianlimab + Cemiplimab for Non-Small Cell Lung Cancer

Recruiting at 79 trial 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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 3 6 8 9}

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

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.

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.

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 Overview The 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

Group I: C: cemiplimab monotherapy+placebo Experimental Treatment 2 Interventions

Phase 2 and Phase 3

Group II: B: fianlimab+cemiplimab Experimental Treatment 2 Interventions

Phase 2: fianlimab (LD) Phase 3: fianlimab (chosen dose)

Group III: A: fianlimab+cemiplimab Experimental Treatment 2 Interventions

Phase 2: fianlimab (HD) Phase 3: fianlimab (chosen dose)

Cemiplimab is already approved in Canada, Brazil for the following indications:

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)

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

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

Findings from Research

In a phase 3 study involving 710 patients with advanced non-small-cell lung cancer and high PD-L1 expression, cemiplimab significantly improved overall survival (not reached) and progression-free survival (8.2 months) compared to chemotherapy (14.2 months).

Cemiplimab also demonstrated a better safety profile, with fewer grade 3-4 treatment-emergent adverse events (28%) compared to chemotherapy (39%), making it a promising first-line treatment option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sezer, A., Kilickap, S., Gümüş, M., et al.[2022]

Cemiplimab-rwlc is a newly approved PD-1/L1 inhibitor for first-line treatment of metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK mutations, either alone or with chemotherapy.

This review highlights the differences in patient populations studied for cemiplimab compared to other treatments, emphasizing its role in expanding options for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. Ahn, J., Nagasaka, M.[2023]

Inhibitory antibodies targeting PD-1 and PD-L1 have significantly improved outcomes for patients with metastatic non-small cell lung cancer (NSCLC), especially when combined with platinum-based chemotherapy, leading to better response rates and increased survival compared to chemotherapy alone.

Pembrolizumab and atezolizumab are approved as first-line treatments for most newly diagnosed metastatic NSCLC patients, demonstrating the potential for immunotherapy to enhance treatment effectiveness, even in specific patient populations with certain genetic mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Changing of the Guard: Immune Checkpoint Inhibitors With and Without Chemotherapy as First Line Treatment for Metastatic Non-small Cell Lung Cancer. Pacheco, JM., Camidge, DR., Doebele, RC., et al.[2023]

Cemiplimab offers significantly longer time in both preprogression and postprogression health states compared to pembrolizumab and chemotherapy, indicating its potential for better patient outcomes in advanced non-small cell lung cancer.

The cost-effectiveness analysis shows that cemiplimab is a viable first-line treatment option, with incremental cost-effectiveness ratios of $68,254 per QALY compared to pembrolizumab and $89,219 per QALY compared to chemotherapy, making it likely to be cost-effective within common willingness-to-pay thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kuznik, A., Smare, C., Chen, CI., et al.[2022]

Cemiplimab-rwlc (Libtayo) is an FDA-approved immunotherapy for advanced cutaneous squamous cell carcinoma (CSCC) that works by blocking the PD-1 receptor, enhancing the immune system's ability to fight tumors.

Clinical trials have shown that cemiplimab is effective in treating CSCC, although common side effects and safety issues were noted, highlighting the need for ongoing research to improve treatment outcomes and reduce toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. Ahmed, SR., Petersen, E., Patel, R., et al.[2019]

Cemiplimab, administered as monotherapy or in combination with hypofractionated radiation therapy, showed a 10% objective response rate in patients with recurrent or metastatic cervical cancer, particularly in those with squamous histology, indicating its potential efficacy in this subgroup.

The most common side effects were diarrhea, fatigue, and hypokalemia, affecting 35%, 25%, and 25% of patients respectively, suggesting that while cemiplimab has anti-tumor activity, it also has a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rischin, D., Gil-Martin, M., González-Martin, A., et al.[2021]

In patients with advanced non-small-cell lung cancer (NSCLC) and high PD-L1 expression (≥50%), cemiplimab showed significant improvements in progression-free survival (PFS) and objective response rate (ORR) compared to pembrolizumab, based on a systematic review and network meta-analysis of randomized-controlled trials.

Cemiplimab demonstrated comparable overall survival (OS) and similar safety profiles to pembrolizumab, indicating it is a viable first-line treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Freemantle, N., Xu, Y., Wilson, FR., et al.[2022]

Atezolizumab, cemiplimab, and pembrolizumab are established as standard first-line immunotherapy options for patients with advanced non-small cell lung cancer (NSCLC) who have high PD-L1 expression (≥50%).

The consensus among 25 Spanish lung cancer experts indicates that these therapies can be tailored to specific patient subgroups, enhancing treatment decision-making based on differences observed in pivotal clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Isla, D., Sánchez, A., Casal, J., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Changing of the Guard: Immune Checkpoint Inhibitors With and Without Chemotherapy as First Line Treatment for Metastatic Non-small Cell Lung Cancer. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. England pubmed.ncbi.nlm.nih.gov

Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

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]

8. England pubmed.ncbi.nlm.nih.gov

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]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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]