Sarilumab + Cemiplimab for Lung Cancer

Overseen By Xiuning Le, MD,PHD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must be taking: EGFR TKI

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Autoimmune disorders, Diabetes, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of two drugs, sarilumab (an immunosuppressive drug) and cemiplimab (an immunotherapy drug), can help manage certain types of non-small cell lung cancer (NSCLC) with specific genetic mutations. Researchers focus on NSCLC with mutations in the EGFR or LKB1/STK11 genes, which can make the cancer harder to treat. The trial includes two groups, one for each type of mutation, and aims to determine if this drug combination can effectively control the cancer. This trial may suit individuals diagnosed with advanced NSCLC who know their cancer has these specific genetic mutations. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this novel combination therapy.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cemiplimab, a drug often used for certain skin cancers, has been thoroughly studied for lung cancer. Over the past three years, safety information for cemiplimab in lung cancer patients has remained consistent, indicating it is generally well-tolerated.

Sarilumab, however, has not been as extensively studied in lung cancer and is usually used for rheumatoid arthritis. Since this combination is in the early stages of testing, limited information exists on how well patients handle both drugs together. Nonetheless, the consistent safety record of cemiplimab in lung cancer is encouraging.

For those considering joining a trial, these findings highlight that cemiplimab has a proven safety record, while sarilumab is still being explored in this context. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Sarilumab and Cemiplimab for lung cancer because these drugs target the disease in a novel way. Unlike traditional treatments such as chemotherapy and EGFR inhibitors, which directly attack cancer cells, these two drugs harness the body's immune system. Cemiplimab is a PD-1 inhibitor that helps the immune system recognize and destroy cancer cells, while Sarilumab is an IL-6 receptor blocker that may reduce inflammation and enhance the immune response. This dual-action approach has the potential to enhance treatment effectiveness and overcome resistance seen with current therapies.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that cemiplimab, when combined with chemotherapy, can significantly improve survival rates for patients with advanced non-small cell lung cancer (NSCLC). Studies have found that this combination can more than double the chances of living for five years compared to chemotherapy alone. This trial examines cemiplimab in combination with sarilumab, typically used for treating inflammation, to determine if it can enhance cancer treatment efficacy. Participants will be divided into two cohorts: Cohort A, focusing on EGFR-mutant NSCLC, and Cohort B, focusing on LKB1-mutant NSCLC. The combination of cemiplimab and sarilumab may target these specific mutations. Although early findings suggest potential benefits, further research is needed to confirm their effectiveness for lung cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Xiuning Le, M.D., Ph.D.

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults over 18 with advanced non-squamous, non-small cell lung cancer (NSCLC) and specific mutations (EGFR or LKB1). They may have had up to three prior treatments but must not be pregnant, breastfeeding, or have severe diseases. Participants need functioning major organs and no recent surgeries. Men and women must agree to use contraception.

Inclusion Criteria

I am a man who can father children and will use birth control during and 3 months after the study.

Patients who meet eligibility criteria to either Cohort A or B will be allowed to enroll to the run-in cohort.

My NSCLC has specific EGFR mutations confirmed by a certified test.

Exclusion Criteria

I have skin ulcers that are healing or not yet healed.

I have not received a live vaccine in the last 3 months.

I do not have serious heart issues like severe heart failure or uncontrolled heart rhythm problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-In

Evaluate the safety of sarilumab and cemiplimab combination in metastatic lung cancer patients

4-6 weeks

Treatment

Participants receive sarilumab and cemiplimab to assess efficacy in EGFR- or LKB1/STK11-mutant NSCLC

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• Sarilumab

Trial Overview The trial is testing the effectiveness of combining two drugs: Sarilumab (Kevzara) and Cemiplimab for NSCLC patients with certain genetic mutations. It aims to control the disease by using these medications together in participants who meet specific genetic criteria.

How Is the Trial Designed?

Group I: Cohort B: LKB1-mutant cohort Experimental Treatment 2 Interventions

Each cohort is planned for 30 Participants with a total of 60 Participants. Participants who are treated in Run-In safety cohort can also be evaluated for efficacy in the molecularly define cohort A or B.

Group II: Cohort A : EGFR-mutant cohort Experimental Treatment 2 Interventions

Each cohort is planned for 30 Participants with a total of 60 Participants. Participants who are treated in Run-In safety cohort can also be evaluated for efficacy in the molecularly define cohort A or B.

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)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Regeneron Pharmaceuticals

Industry 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

Published Research Related to This Trial

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]

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]

Cemiplimab, a PD-1 inhibitor, demonstrated an objective response rate of 25% in patients with advanced non-small cell lung cancer (NSCLC) who had previously undergone treatment, indicating its potential effectiveness in this challenging patient population.

The treatment was generally well-tolerated, although 60% of patients experienced severe treatment-emergent adverse events, highlighting the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and antitumor activity of cemiplimab, a human monoclonal anti-PD-1, as monotherapy in patients with pretreated non-small cell lung cancer (NSCLC): Data from the Phase 1 NSCLC expansion cohort. Moreno, V., Garrido, P., Papadopoulos, KP., et al.[2021]

In the EMPOWER-Lung 1 trial, cemiplimab significantly improved overall survival compared to platinum-doublet chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (≥50%).

Patients receiving cemiplimab reported better quality of life and functioning, with a lower risk of definitive deterioration in symptoms such as dyspnea, cough, and fatigue, indicating that cemiplimab not only extends survival but also enhances the patient's overall well-being.

NCBI (Pubmed)

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. Gümüş, M., Chen, CI., Ivanescu, C., et al.[2023]

Cemiplimab showed the most favorable overall survival (OS) compared to other PD-1/PD-L1 inhibitors and chemotherapy, indicating it may be the best option for treating non-small cell lung cancer (NSCLC) patients based on a network meta-analysis of multiple studies.

All PD-1/PD-L1 inhibitors, including cemiplimab, had fewer treatment-related adverse events (TRAEs) compared to chemotherapy, suggesting a better safety profile for these immunotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Efficacy and Safety of Anti-PD-1/PD-L1 for the Treatment of Non-Small Cell Lung Cancer: A Network Meta-Analysis of 13 Randomized Controlled Studies. Jiang, M., Liu, C., Ding, D., et al.[2023]

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]

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]

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]

Citations

1. newsroom.regeneron.com newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-plus-chemotherapy-results-five-years

Libtayo® (cemiplimab) Plus Chemotherapy Results at Five ... Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00573

Sarilumab in Combination with Cemiplimab for the ... This phase Ib trial tests the safety and effectiveness of sarilumab in combination with cemiplimab in treating patients with mutated EGFR or LKB1/STK11 non- ...

3. globenewswire.com globenewswire.com/news-release/2025/09/09/3146733/0/en/Libtayo-cemiplimab-Plus-Chemotherapy-Results-at-Five-Years-Reinforce-Significant-and-Durable-Improvements-in-Survival-Outcomes-for-Advanced-Non-small-Cell-Lung-Cancer.html

Libtayo® (cemiplimab) Plus Chemotherapy Results at Five Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall ...

4. investor.regeneron.com investor.regeneron.com/news-releases/news-release-details/regeneron-showcases-advances-across-oncology-portfolio-and

Release Details New safety and pharmacokinetic data from Phase 3 C-POST trial provide insights on an every 6-week dosing regimen of adjuvant Libtayo® ...

5. ajmc.com ajmc.com/view/cemiplimab-shows-5-year-survival-benefit-in-advanced-nsclc-with-high-pd-l1-expression

Cemiplimab Shows 5-Year Survival Benefit in Advanced ... Cemiplimab significantly improved overall survival and progression-free survival compared to chemotherapy in advanced NSCLC with high PD-L1 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05704634

NCT05704634 | A Phase Ib Study to Evaluate the Safety ... To evaluate the safety of sarilumab cemiplimab combination in metastatic lung cancer patients. The primary endpoint is DLT for safety Run-In cohort. To ...

7. libtayohcp.com libtayohcp.com/nsclc/safety/monotherapy/follow-up-data

LIBTAYO safety profile in EMPOWER-Lung 1: 3-year data 1 Three year safety profile data in the EMPOWER-Lung 1 study for LIBTAYO in advanced NSCLC (non-small cell lung cancer). Review Important Safety Information and

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10477992/

Metabolic barriers in non-small cell lung cancer with LKB1 ... This review provides a comprehensive summary of the clinical efficacies of current therapeutic strategies against NSCLC harboring LKB1 and/or KEAP1 mutations.

9. ckb-core.genomenon.com ckb-core.genomenon.com/therapy/show/14637

Therapy Detail - CKB CORE - Genomenon Libtayo (cemiplimab) is FDA approved for use in patients with cutaneous squamous cell carcinoma, who are not not eligible for curative surgery or radiation, in ...