Chemo-Immunotherapy for Lung Cancer

(NEO-SURG Trial)

Recruiting at 3 trial locations

Overseen By Joshua Reuss, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Georgetown University

Must be taking: Platinum-doublet chemotherapy

Must not be taking: Systemic immunosuppressants

Disqualifiers: Autoimmune disease, HIV, Hepatitis, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a combination of chemotherapy and immunotherapy can assist patients with stage 3 non-small cell lung cancer (NSCLC), particularly those with specific lymph node involvement, in undergoing successful cancer-removal surgery. Participants will receive a mix of chemotherapy and the immunotherapy drug cemiplimab before surgery, followed by cemiplimab for a year post-surgery. The study seeks individuals with stage 3 NSCLC whose doctors have indicated that their tumor is surgically removable. As a Phase 2 trial, this research focuses on assessing 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 systemic immunosuppressive medication, you may need to stop it at least 2 weeks before starting the study treatment, unless it's a low-dose or specific type allowed by the trial.

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

Research shows that cemiplimab, when combined with chemotherapy, is safe for treating advanced non-small cell lung cancer (NSCLC). Studies have found that most patients tolerate this treatment well. Specifically, patients report that side effects are manageable and don't significantly impact their quality of life.

Cemiplimab is a medicine that helps the immune system identify and attack cancer cells. When paired with standard chemotherapy, many patients experience long-lasting benefits. Reports indicate that this treatment has led to promising survival rates over several years.

These findings suggest that cemiplimab plus chemotherapy is safe for many people with NSCLC. However, like any treatment, side effects may occur, so discussing potential risks with a healthcare team is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Researchers are excited about cemiplimab for lung cancer because it’s part of a new wave of treatments called immunotherapies. Unlike traditional chemotherapy, which attacks cancer cells directly, cemiplimab works by helping the body’s immune system recognize and fight the cancer cells. This can potentially lead to more targeted and effective treatment with fewer side effects. Additionally, when combined with chemotherapy, cemiplimab is being studied for its ability to enhance the overall effectiveness of treatment, potentially improving outcomes for patients both before and after surgery.

What evidence suggests that this trial's treatments could be effective for stage 3 NSCLC?

Research has shown that cemiplimab, when combined with chemotherapy, can help treat non-small cell lung cancer (NSCLC). One study found that patients receiving cemiplimab with chemotherapy lived for a median of 21.1 months, compared to 12.9 months for those who only had chemotherapy. Additionally, long-term results revealed that 19.4% of patients treated with this combination were still alive after five years. This trial will evaluate cemiplimab plus chemotherapy, suggesting that this combination may extend the lives of patients with advanced NSCLC. ^{1 6 7 8 9}

Who Is on the Research Team?

Joshua Reuss, MD

Principal Investigator

Georgetown University

Are You a Good Fit for This Trial?

This trial is for individuals with stage III non-small cell lung cancer (NSCLC) that has spread to certain lymph nodes. Candidates must be eligible for surgery after receiving chemotherapy and immunotherapy. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

My surgeon believes my tumor can be surgically removed with the goal of curing me.

My surgeon has cleared me for surgery without major health risks.

My lungs are strong enough for the surgery my doctor recommends.

Exclusion Criteria

I have active tuberculosis.

I have a history of uncontrolled HIV or hepatitis.

I have not had a severe infection in the last 3 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive a combination of cemiplimab and platinum-doublet chemotherapy for 4 cycles, administered every 3 weeks before surgery

12 weeks

Surgical Resection

Participants undergo surgical resection to remove the cancer

Adjuvant Treatment

Participants receive cemiplimab every 3 weeks for one year after surgery

1 year

Radiation Therapy (optional)

Participants may undergo radiation therapy if recommended by their treatment team

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab

Trial Overview The study tests if patients can have successful surgery to remove NSCLC after treatment with platinum-doublet chemotherapy and cemiplimab, an immunotherapy drug targeting PD-1. Post-surgery, optional radiation therapy and additional cemiplimab treatments for one year are considered.

How Is the Trial Designed?

Group I: Cemiplimab plus chemotherapy Experimental Treatment 1 Intervention

cemiplimab given with standard of care chemotherapy for 4 treatments/cycles before surgery and then every 3 weeks for 1 year after surgery.

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?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

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

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]

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 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]

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 (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]

Immune checkpoint inhibitors, such as ipilimumab and anti-PD-1 agents like nivolumab and pembrolizumab, work by enhancing the immune system's ability to fight non-small cell lung cancer (NSCLC), differing from traditional chemotherapy that targets tumor cells directly.

Preliminary evidence indicates that these inhibitors can be effective as standalone treatments or in combination with chemotherapy, highlighting their potential in improving outcomes for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging immunotherapies in the treatment of non-small cell lung cancer (NSCLC): the role of immune checkpoint inhibitors. Langer, CJ.[2020]

Immunotherapy is becoming a key part of first-line treatment for non-small cell lung cancer (NSCLC), with various phase 3 studies showing the effectiveness of drugs targeting PD-1, PD-L1, and CTLA-4, often in combination with chemotherapy.

Patients with high PD-L1 expression (≥ 50%) can be treated with single-agent Pembrolizumab or Atezolizumab, while those with lower expression have multiple treatment options, including combinations of immunotherapy and chemotherapy, highlighting the tailored approach based on tumor characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First line Immunotherapy for Non-Small Cell Lung Cancer. Nasser, NJ., Gorenberg, M., Agbarya, A.[2020]

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]

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. libtayohcp.com libtayohcp.com/nsclc/efficacy/monotherapy/response-rates

Efficacy overview - LIBTAYO® (cemiplimab-rwlc) Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 61% of the 33 patients. Of the 18 patients in whom LIBTAYO was ...

3. ajmc.com ajmc.com/view/survival-outcomes-in-advanced-nsclc-improved-with-use-of-cemiplimab

Survival Outcomes in Advanced NSCLC Improved ... - AJMC The EMPOWER-Lung 3 trial showed a median overall survival of 21.1 months with cemiplimab versus 12.9 months with chemotherapy alone.

4. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/empower-lung-confirms-five-year-survival-benefit-libtayo-chemotherapy-nsclc

Phase III EMPOWER-Lung 3 Trial Confirms Five-Year ... Five-year results from the Phase III EMPOWER-Lung 3 trial show Libtayo combined with chemotherapy achieved a 19.4% overall survival rate ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e20572

Evaluating the safety and effectiveness of cemiplimab in ... RW effectiveness endpoints to be evaluated include response rate, duration of response, progression-free survival, and overall survival. Patient ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12140711/

Safety, efficacy, and quality of life with cemiplimab ... Immune checkpoint inhibitors have shown promise in treating advanced non-small cell lung cancer and have a solid safety profile. Cemiplimab ...

7. libtayohcp.com libtayohcp.com/nsclc/efficacy/combination-therapy/patient-reported-outcomes

Patient-reported outcomes - LIBTAYO® (cemiplimab-rwlc) View the statistical analysis of patient reported outcomes of NSCLC treatment with LIBTAYO® + chemotherapy vs. placebo + chemotherapy.

8. jto.org jto.org/article/S1556-0864(25)00240-0/fulltext

45P: Extended follow-up confirmed real-world efficacy and ... Our previous analyses showed that cemiplimab monotherapy has a favorable safety profile and efficacy outcomes in NSCLC with high PD-L1 expression.

9. onclive.com onclive.com/view/cemiplimab-plus-chemotherapy-provides-long-term-survival-benefit-in-advanced-nsclc

Cemiplimab Plus Chemotherapy Provides Long-Term ... The 12-, 24-, 36-, and 60-month OS rates with cemiplimab plus chemotherapy were 66.4%, 43.9%, 33.2%, and 19.4%, respectively; with chemotherapy ...