Cemiplimab + Chemotherapy for Lung Cancer

Recruiting at 39 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Disqualifiers: Oncogenic alterations, Peripheral neuropathy, 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: 1

Duration: 12-16 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with early-stage non-small cell lung cancer scheduled for surgery. It compares the effectiveness of a combination of the immunotherapy drug cemiplimab, standard chemotherapy, and an additional experimental drug (REGN7075) against cemiplimab and chemotherapy alone. Researchers aim to learn about side effects, how the treatments might affect surgical options, and how the body reacts to these drugs. Suitable participants have lung cancer that can be surgically removed. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

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

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

Research has shown that cemiplimab, when combined with chemotherapy, is generally well-tolerated by patients with advanced solid tumors. Studies have also found that adding REGN7075 to cemiplimab remains safe, even with chemotherapy. These studies focus on safety and tolerability, examining how patients manage side effects and the overall safety of the treatment.

Some patients in earlier studies experienced side effects, but these were mostly manageable. It is important to note that these findings come from early testing stages, and researchers continue to gather safety information. However, the FDA's approval of cemiplimab for other uses provides some reassurance about its safety.

For those considering participation in this clinical trial, this information may offer insight into the potential safety and tolerability of the treatments being tested. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about cemiplimab combined with chemotherapy for lung cancer because it introduces a new approach by enhancing the immune response against cancer cells. While standard treatments like chemotherapy attack cancer directly, cemiplimab is an immunotherapy that works by blocking the PD-1 pathway, helping the immune system recognize and fight cancer more effectively. In addition to this, the investigational treatment arm includes REGN7075, a novel agent that may further enhance the immune response. This combination could potentially offer improved outcomes compared to current treatment options.

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

Research shows that cemiplimab, when combined with chemotherapy, has potential in treating non-small cell lung cancer. In this trial, one group of participants will receive this combination. Another group will receive an investigational treatment that adds REGN7075, a new drug that helps the immune system find and attack cancer cells, to cemiplimab and chemotherapy. Early results suggest that adding REGN7075 could enhance the treatment's effectiveness. Initial studies demonstrated that REGN7075 can shrink tumors, even when other treatments have failed. While more research is needed, these early findings offer hope for better treatment options. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

Adults with early-stage (II-IIIB) NSCLC, who are fit for surgery, can join this trial. They should have measurable disease, be in good physical condition (ECOG PS 0-1), and have proper organ/bone marrow function. A confirmed diagnosis that's resectable for cure is needed, along with a tumor sample block.

Inclusion Criteria

This criterion requires more specific information to provide a summary.

My lung cancer is at a stage where surgery could cure it.

My cancer can be measured by standard health scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cemiplimab plus chemotherapy, with or without an additional investigational drug

12-16 weeks

Weekly visits (in-person)

Surgery

Participants undergo planned surgical resection of non-small cell lung cancer

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

76 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• Platinum-based chemotherapy
• REGN7075

Trial Overview

The study tests if adding REGN7075 to cemiplimab plus chemotherapy improves outcomes versus just cemiplimab and chemo in NSCLC patients awaiting surgery. It also examines side effects, surgical impacts, drug levels in blood, and potential antibodies against the drugs.

How Is the Trial Designed?

Group I: Arm 1: Chemotherapy+Cemiplimab+REGN7075 Experimental Treatment 3 Interventions

Investigational Treatment

Group II: Chemotherapy+Cemiplimab Active Control 2 Interventions

Control treatment

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?

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

Published Research Related to This Trial

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]

The combination of paclitaxel and carboplatin has shown promising results in treating advanced non-small-cell lung cancer (NSCLC), with reported 1-year survival rates as high as 54%, making it a widely used regimen in clinical practice.

This combination therapy has been effective without additional toxicity, allowing for full doses of both drugs to be administered, and is currently being evaluated in ongoing studies for earlier stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel/carboplatin in the treatment of non-small-cell lung cancer. Belani, CP.[2015]

In a study of 126 patients with advanced non-small cell lung cancer (NSCLC), both vinorelbine/cisplatin and vinorelbine/oxaliplatin regimens showed similar overall response rates, indicating both are effective treatments.

However, vinorelbine/oxaliplatin was associated with significantly lower rates of severe leukopenia and gastrointestinal reactions compared to vinorelbine/cisplatin, although it resulted in higher neurotoxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Randomly clinical study of vinorelbine/cisplatin and vinorelbine/oxaliplatin regimens in the treatment of advanced non-small cell lung cancer]. Wang, X., Hou, M., Cao, D., et al.[2010]

Chemotherapy, particularly with platinum-based drugs like cisplatin and carboplatin, is a standard treatment for patients with locally advanced or metastatic non-small-cell lung cancer, showing a beneficial survival effect confirmed by clinical studies.

Research is ongoing into new platinum agents, such as BBR3464 and ZD0473, which may offer alternatives to existing treatments and could be combined with other drugs to improve outcomes for patients with advanced or resistant solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platinum drugs in the treatment of non-small-cell lung cancer. Cosaert, J., Quoix, E.[2023]

In a study of 62 elderly patients (median age 72) with advanced non-small cell lung cancer, first-line chemotherapy using a platinum-based doublet (carboplatin or cisplatin) was found to be effective, resulting in a median overall survival of 9.8 months.

The treatment was generally safe, with mild toxicity observed; only 8% of cycles resulted in grade III-IV neutropenia, indicating that platinum-based chemotherapy can be a viable option for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platinum doublets as first-line treatment for elderly patients with advanced non-small cell lung cancer. Piacentini, P., Greco, F., Mercanti, A., et al.[2022]

In a study of 89 patients with advanced nonsmall cell lung cancer, both carboplatin plus paclitaxel and gemcitabine plus vinorelbine showed similar 1-year survival rates below 30%, indicating limited efficacy for both treatment regimens.

Both treatment combinations resulted in significant toxicities, with carboplatin plus paclitaxel causing more nausea and gemcitabine plus vinorelbine leading to higher rates of anemia and treatment-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized phase II study of carboplatin-paclitaxel or gemcitabine-vinorelbine in patients with advanced nonsmall cell lung cancer and a performance status of 2: West Japan Thoracic Oncology Group 0004. Saito, H., Nakagawa, K., Takeda, K., et al.[2022]

Carboplatin has shown comparable efficacy to cisplatin in treating non-small cell lung cancer (NSCLC) and can be effectively used in combination chemotherapy, providing similar survival benefits.

Ongoing clinical trials are exploring various strategies to optimize carboplatin use, including dose adjustments, combinations with other treatments like stem-cell support and radiation therapy, and interactions with new agents like TAXOL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin in the treatment of non-small cell lung cancer: a review. Comis, RL.[2018]

The combination of gemcitabine and carboplatin is well tolerated in chemotherapy-naive patients with advanced non-small-cell lung cancer, with a recommended dose of gemcitabine at 1,100 mg/m2 and carboplatin at AUC 5 for further studies.

This treatment showed a 50% objective response rate, including 15% complete responses, and a median overall survival of 16 months, indicating its efficacy is comparable to existing treatments like cisplatin-gemcitabine, with potentially better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I-II study of gemcitabine and carboplatin in stage IIIB-IV non-small-cell lung cancer. Iaffaioli, RV., Tortoriello, A., Facchini, G., et al.[2022]

The standard first-line treatment for advanced non-small-cell lung cancer involves using a platinum drug combined with another chemotherapy agent, with cisplatin being the most commonly used platinum drug.

Gemcitabine combined with carboplatin is highlighted as a convenient and safer alternative, offering a favorable toxicity profile while still being effective for patients with good performance status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine and carboplatin in combination for the treatment of advanced, metastatic, non-small cell lung cancer. Nagel, S., Califano, R., Thatcher, N., et al.[2022]

Cisplatin combined with either a vinca alkaloid or etoposide is highly effective in reducing mortality for patients with non-small cell lung cancer, as shown in meta-analyses comparing chemotherapy to supportive care.

Recent studies indicate that combining cisplatin-based chemotherapy with new agents and radiotherapy can significantly prolong survival and improve outcomes for patients with locally advanced non-small cell lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chemotherapy for non-small cell lung cancer]. Shinkai, T., Saijo, N.[2018]

In a phase I/II study involving 21 patients with advanced non-small cell lung cancer, the combination of carboplatin and vinorelbine was found to be very well tolerated, with only one case of severe hematological toxicity and one case of significant nonhematological toxicity.

The regimen showed objective responses in patients, suggesting that carboplatin combined with vinorelbine could be an effective treatment option worth further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin and vinorelbine in advanced non-small cell lung cancer: a phase I/II study. Masters, G.[2019]

Cisplatin-based chemotherapy significantly improves survival and symptom control in stage IV non-small cell lung cancer patients with good performance status, suggesting its effectiveness as a primary treatment option.

Combination regimens including cisplatin and at least one other active drug (like ifosfamide or gemcitabine) are recommended, with four to six cycles proposed for patients who respond well, while non-platinum options can be considered for those unable to tolerate platinum-based treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stage IV NSCLC. Place of chemotherapy]. Meert, AP.[2013]

Citations

1.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2503

A phase 1/2 study of REGN7075 in combination with ...

REGN7075, a first-in-class costimulatory bispecific antibody (bsAb), aims to restore immune sensitivity in traditionally non-immunoresponsive tumors.

2.

investor.regeneron.com

investor.regeneron.com/news-releases/news-release-details/promising-anti-tumor-activity-novel-costimulatory-bispecific

Promising Anti-tumor Activity of Novel Costimulatory ...

REGN7075 is one of the first immunotherapies to demonstrate clinical activity in MSS CRC, including in a patient with liver metastases.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04626635

NCT04626635 | A Trial to Find Out How Safe REGN7075 is ...

Another aim of the study is to see how effective REGN7075 by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1556086424015806

P4.11D.04 A Phase 1/2 Study of REGN7075 (EGFRÃ- ...

Here, we focus on three non-small cell lung cancer (NSCLC) cohorts in the dose expansion phase. The study includes a dose escalation (Part 1) ...

5.

meetings.asco.org

meetings.asco.org/abstracts-presentations/228919

A phase 1/2 study of REGN7075 (EGFRxCD28 ...

This is an open-label, Phase 1/2, first-in-human, international study evaluating the safety, tolerability, PK, and anti-tumor activity of REGN7075 ± cemiplimab ...

6.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.TPS277

A phase 1/2 study of REGN7075 (EGFRxCD28 ...

Primary endpoints are safety and tolerability of REGN7075 alone or in combination with cemiplimab for Part 1, and objective response rate per ...