Cemiplimab + Chemotherapy for Lung Cancer

Recruiting at 26 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

Trial Summary

What is the purpose of this trial?

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned. The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug. The study is also looking at several other research questions, including: * What are the side effects associated with the investigational treatments in comparison to the control treatment? * Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed? * How much of the study drug(s) are in the blood at a given time? * Does the body make antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)?

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.

What data supports the effectiveness of the drug Cemiplimab + Chemotherapy for Lung Cancer?

Research shows that combining carboplatin with other drugs like paclitaxel or gemcitabine has been effective in treating advanced non-small cell lung cancer, with notable improvements in response and survival rates. This suggests that using carboplatin as part of a combination therapy could be beneficial for lung cancer treatment. ^{1 2 3 4 5}

Is the combination of Cemiplimab and chemotherapy safe for treating lung cancer?

The studies reviewed focus on the safety of platinum-based chemotherapy, such as carboplatin and cisplatin, in treating lung cancer. Carboplatin combined with vinorelbine was well tolerated, with only one severe blood-related side effect and one severe non-blood-related side effect reported. Cisplatin-based regimens, while effective, are noted for having severe side effects. ^{6 7 8 9 10}

How is the drug Cemiplimab combined with chemotherapy unique for lung cancer treatment?

Cemiplimab combined with platinum-based chemotherapy is unique because it includes an immunotherapy component (Cemiplimab) that helps the immune system fight cancer cells, which is different from traditional chemotherapy that directly targets and kills cancer cells. This combination aims to enhance the overall effectiveness of treatment by leveraging both the immune system and chemotherapy. ^{1 2 3 11 12}

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Gemcitabine and carboplatin in combination for the treatment of advanced, metastatic, non-small cell lung cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Phase I-II study of gemcitabine and carboplatin in stage IIIB-IV non-small-cell lung cancer. [2022]

6. China 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]. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Platinum doublets as first-line treatment for elderly patients with advanced non-small cell lung cancer. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

9. France pubmed.ncbi.nlm.nih.gov

[Stage IV NSCLC. Place of chemotherapy]. [2013]

10. United States 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. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Chemotherapy for non-small cell lung cancer]. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Platinum drugs in the treatment of non-small-cell lung cancer. [2023]