Cemiplimab + BNT116 for Non-Small Cell Lung Cancer

Recruiting at 96 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Immunostimulatory agents

Disqualifiers: Never smoked, Brain metastases, EGFR mutations, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 136 weeks

51 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two drugs, BNT116 (also known as FIXVAC Lung, an experimental treatment) and cemiplimab, for individuals with advanced non-small cell lung cancer (NSCLC). The goal is to assess the safety and effectiveness of these drugs when used together, compared to cemiplimab alone. Researchers also examine potential side effects, how the body processes the drugs, and whether resistance develops. This trial suits individuals with NSCLC that cannot be treated with surgery or radiation and who have not received prior treatment for advanced stages of this cancer. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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 greater than 5 mg of prednisone per day, you must stop it at least 14 days before joining the trial.

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

Research has shown that cemiplimab is generally safe for treating advanced non-small cell lung cancer (NSCLC). In studies, a few patients experienced lung inflammation, but this was uncommon, affecting only 2.6% of patients, with severe cases being even rarer.

Early studies indicate that BNT116 is usually well-tolerated. When combined with cemiplimab, the side effects appear manageable, though further research is needed for a complete understanding.

Both treatments have been studied alone and together, and the safety results so far are promising. However, gathering more data remains important to confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of BNT116 and Cemiplimab for non-small cell lung cancer because it introduces a novel approach to treatment. Unlike traditional chemotherapy, which directly kills cancer cells, Cemiplimab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. BNT116, on the other hand, is a cancer vaccine designed to further stimulate the immune response against the tumor. This dual approach could potentially offer more precise targeting of cancer cells while minimizing damage to healthy tissue, setting it apart from existing treatments.

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

Research has shown that cemiplimab, which participants in this trial may receive, offers significant benefits for people with advanced non-small cell lung cancer (NSCLC). Studies found it helps patients live longer and slows the disease more effectively than chemotherapy. Patients with high levels of PD-L1, a protein that allows cancer to evade the immune system, experienced major improvements.

Another treatment arm in this trial involves the combination of BNT116 and cemiplimab. Early results suggest this combination is generally safe and shows promise in shrinking tumors for patients whose cancer continued to grow despite other treatments. This combination enhances the body's immune system to fight cancer more effectively. Initial data indicate encouraging rates of disease control and slowing of disease progression in advanced NSCLC cases. ^{1 3 4 6 7}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

Adults with advanced non-small cell lung cancer (NSCLC) who have not had prior treatments for metastatic disease, and whose tumors show high levels of PD-L1 protein. Participants should be in relatively good physical condition (ECOG ≤1), able to provide a tumor tissue sample, and not have other serious health issues or infections like HIV or hepatitis.

Inclusion Criteria

I am fully active or can carry out light work.

I can provide a sample of my tumor that has been preserved.

I have at least one tumor that can be measured on a scan.

Exclusion Criteria

Participants who have never smoked, defined as smoking ≤100 cigarettes in a lifetime

I haven't taken more than 5 mg of prednisone or its equivalent daily in the last 2 weeks.

I do not have an uncontrolled HIV, HBV, or HCV infection, nor an immunodeficiency.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BNT116 in combination with cemiplimab or cemiplimab monotherapy. BNT116 is administered by IV injection and cemiplimab by IV infusion every 3 weeks.

Up to 136 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of progression-free survival and overall survival.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• BNT116
• Cemiplimab

Trial Overview The trial is testing the safety and effectiveness of BNT116 in combination with cemiplimab versus using cemiplimab alone. It aims to understand how well these drugs work together to treat NSCLC, what side effects may occur, drug levels in blood over time, and if the body develops antibodies against them.

How Is the Trial Designed?

Group I: Phase 2: Cemiplimab Experimental Treatment 1 Intervention

Arm A: Cemiplimab is administered by IV infusion Q3W

Group II: Phase 2: BNT116 + Cemiplimab Experimental Treatment 2 Interventions

Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.

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

BioNTech SE

Industry Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Published Research Related to This Trial

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]

In a phase II study involving 53 patients with advanced non-small cell lung cancer, the combination of cetuximab, paclitaxel, and carboplatin resulted in a response rate of 57%, indicating significant clinical activity.

The treatment was well tolerated with manageable toxicities, including rash and neutropenia, and no grade 5 toxicities reported, suggesting a favorable safety profile for this regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of paclitaxel, carboplatin, and cetuximab as first line treatment, for patients with advanced non-small cell lung cancer (NSCLC): results of OPN-017. Borghaei, H., Langer, CJ., Millenson, M., et al.[2018]

Cetuximab-based therapy (CBT) in combination with first-line platinum-based chemotherapy for advanced non-small-cell lung cancer (NSCLC) showed a 13% reduction in the risk of death and a 9% reduction in disease progression compared to standard treatment, based on a meta-analysis of four randomized controlled trials involving over 2,000 patients.

CBT resulted in a significant increase in the objective response rate by approximately 50%, while the adverse events were similar to those seen with standard treatments, indicating that CBT offers a meaningful clinical benefit with manageable toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cetuximab-based therapy is effective in chemotherapy-naïve patients with advanced and metastatic non-small-cell lung cancer: a meta-analysis of randomized controlled trials. Ibrahim, EM., Abouelkhair, KM., Al-Masri, OA., et al.[2021]

Immune checkpoint inhibitors have significantly improved survival rates in many patients with non-small cell lung cancer (NSCLC) and generally have a good safety profile, but not all patients respond positively to these treatments.

Combination strategies involving chemotherapy or radiotherapy with immunotherapy are being explored to enhance treatment efficacy, as some patients may experience accelerated tumor progression with PD-1 or PD-L1 inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of immunotherapy with chemotherapy and radiotherapy in lung cancer: is this the beginning of the end for cancer? Lazzari, C., Karachaliou, N., Bulotta, A., et al.[2022]

In a phase II study involving 167 patients with stage IV squamous non-small-cell lung cancer, the combination of necitumumab with paclitaxel-carboplatin chemotherapy resulted in a higher objective response rate (48.9%) compared to chemotherapy alone (40.0%).

The safety profile of necitumumab was consistent with other EGFR monoclonal antibodies, with increased rates of hypomagnesemia and rash, but overall adverse events were low, indicating that necitumumab can be safely combined with chemotherapy for improved treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open-Label, Randomized, Controlled Phase II Study of Paclitaxel-Carboplatin Chemotherapy With Necitumumab Versus Paclitaxel-Carboplatin Alone in First-Line Treatment of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer. Spigel, DR., Luft, A., Depenbrock, H., et al.[2022]

Recent advancements in treating non-small cell lung cancer (NSCLC) have led to the development of newer chemotherapeutic agents, achieving single-agent response rates of 20% or higher.

The combination of carboplatin and paclitaxel has shown promising results, with response rates as high as 62%, and ongoing Phase III trials are exploring its role in NSCLC treatment alongside newer agents and biologically based therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of paclitaxel/carboplatin in advanced non-small cell lung cancer. Bonomi, P.[2015]

In a study involving 86 patients with advanced non-small-cell lung cancer (NSCLC), the combination of cetuximab with cisplatin and vinorelbine showed a confirmed response rate of 35%, compared to 28% for cisplatin and vinorelbine alone.

The combination treatment also resulted in a median survival of 8.3 months, compared to 7.3 months for the standard treatment, indicating a potential improvement in efficacy while maintaining a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer. Rosell, R., Robinet, G., Szczesna, A., et al.[2021]

In a phase II study involving 155 patients with advanced non-small-cell lung cancer (NSCLC), the combination of bortezomib and pemetrexed showed a response rate of 7%, which was not significantly better than pemetrexed alone (4%) or bortezomib alone (0%).

While the combination treatment was well tolerated, it did not provide a statistically significant survival advantage over pemetrexed alone, with median overall survival of 8.6 months for the combination compared to 12.7 months for pemetrexed alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized phase II study of bortezomib and pemetrexed, in combination or alone, in patients with previously treated advanced non-small-cell lung cancer. Scagliotti, GV., Germonpré, P., Bosquée, L., 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]

PD-1/PD-L1 inhibitors have limited effectiveness in patients with low PD-L1 expression in advanced non-small cell lung cancer (NSCLC), highlighting the need for improved treatment options.

Dual immunotherapy, combining PD-1 and CTLA-4 inhibitors, shows promise for better long-term survival in NSCLC, with ongoing research focused on identifying optimal patient groups and ensuring safety through multidisciplinary approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dual Immunotherapy in Advanced Non-small Cell Lung Cancer: the Progress and Clinical Application]. Deng, H., Wang, L., Yang, Y., et al.[2022]

Recent advancements have led to the development of new drugs like irinotecan, paclitaxel, and docetaxel that show higher response rates in treating non-small cell lung cancer (NSCLC) compared to older treatments, which had a low overall response rate of only 15%.

Combination chemotherapy regimens using these newer agents have demonstrated promising efficacy in NSCLC, and ongoing randomized controlled trials are working to establish even more effective treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New chemotherapeutic agents for the treatment of non-small cell lung cancer: the Japanese experience. Saijo, N.[2019]

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. clinicaltrials.biontech.com clinicaltrials.biontech.com/trials/BNT116-01

Clinical Trial Evaluating the Safety, Tolerability and ... This first-in-human (FIH) trial for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination ...

2. jitc.bmj.com jitc.bmj.com/content/12/Suppl_3/A1716

1486 Preliminary results from LuCa-MERIT-1, a phase I ... In this preliminary analysis, BNT116+cemiplimab had a manageable safety profile and showed encouraging DCR and PFS in patients previously progressing on PD-1 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05557591

NCT05557591 | A Trial to Learn How the Cancer Vaccine ... The aims of this study are to see how safe and tolerable BNT116 is in combination with cemiplimab and to see how effective BNT116 in combination with cemiplimab ...

4. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT013/761601/Abstract-CT013-Phase-I-trial-evaluating-BNT116-a

Abstract CT013: Phase I trial evaluating BNT116, a TAA ... We present preliminary data for BNT116 plus cemiplimab in frail patients with advanced or metastatic NSCLC who were not eligible for PBC as first-line ...

5. lungcancerstoday.com lungcancerstoday.com/post/data-on-rna-based-cancer-vaccine-plus-cemiplimab-for-nsclc-presented-at-aacr-2025

Data on RNA-Based Cancer Vaccine Plus Cemiplimab for ... Combining an RNA-based lipoplex cancer vaccine with cemiplimab showed “promising anti-tumor activity” in patients with advanced non-small cell lung cancer ( ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05142189

Study Details | NCT05142189 | Clinical Trial Evaluating the ... This first-in-human (FIH) trial for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05557591

NCT05557591 | A Trial to Learn How the Cancer Vaccine ... The aims of this study are to see how safe and tolerable BNT116 is in combination with cemiplimab and to see how effective BNT116 in combination with cemiplimab ...