Sarilumab + Cemiplimab for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Xiuning Le, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

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

Trial Summary

What is the purpose of this trial?

To learn if the combination of sarilumab (also called Kevzara) and cemiplimab can help to control EGFR- or LKB1/STK11-mutant NSCLC.

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.

What data supports the effectiveness of the drug combination Sarilumab and Cemiplimab for lung cancer?

Cemiplimab has been shown to improve survival in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression, making it an effective option for this type of cancer. ^{1 2 3 4 5}

Is cemiplimab safe for use in humans?

Cemiplimab has been studied in clinical trials for non-small cell lung cancer and cutaneous squamous cell carcinoma, showing common side effects and safety issues typical of immunotherapy drugs. It is generally considered safe, but like other immunotherapies, it can cause side effects related to immune system activation. ^{1 2 3 6 7}

What makes the drug combination of Sarilumab and Cemiplimab unique for lung cancer treatment?

The combination of Sarilumab and Cemiplimab for lung cancer is unique because it pairs an anti-inflammatory drug (Sarilumab) with an immunotherapy drug (Cemiplimab), which is a PD-1 inhibitor that enhances the immune system's ability to fight cancer. This combination may offer a novel approach by potentially reducing inflammation while boosting the immune response against cancer cells. ^{1 2 3 7 8}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Cemiplimab (Checkpoint Inhibitor)
• Sarilumab (Monoclonal Antibodies)

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.

Participant Groups

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

Regeneron Pharmaceuticals Industry Sponsor

References

1. 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] 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.

2. 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] 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.

3. 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] 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%.

4. Switzerland 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. [2023] The present network meta-analysis (NMA) was conducted to summarize the direct and indirect evidence of common programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitors including avelumab, atezolizumab, cemiplimab, nivolumab, and pembrolizumab for the treatment of non-small cell lung cancer (NSCLC) patients and further to determine the optimal therapeutic regimen.

5. 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] 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.

6. 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] 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.

7. England pubmed.ncbi.nlm.nih.gov

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.

8. Ireland 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. [2021] Blockade of programmed cell death-1 (PD-1) and its ligand (PD-L1) has transformed the treatment of NSCLC. In a first-in-human, Phase 1, dose escalation and cohort expansion study, cemiplimab, a monoclonal antibody directed against PD-1, was evaluated for the treatment of patients with advanced solid tumors (NCT02383212). Here, we report results in patients with advanced NSCLC from the dose expansion cohort.