Cemiplimab for Non-Small Cell Lung Cancer

Recruiting at 237 trial locations

Overseen By SWOG Network Operations Center

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: SWOG Cancer Research Network

Must be taking: Anti-PD-1, Anti-PD-L1

Must not be taking: Immunosuppressives, Live vaccines

Disqualifiers: Autoimmune disease, Organ transplant, Cardiac disease, 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: 4

Duration: 21-day cycles, repeated until disease progression or unacceptable toxicity

378 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding cemiplimab to the usual treatment of docetaxel and ramucirumab is more effective for stage IV or recurring non-small cell lung cancer. Cemiplimab helps the immune system identify and attack cancer cells by blocking a pathway tumors use to hide. Participants with stage IV or recurring non-small cell lung cancer who have not responded to anti-PD-1 therapy might be suitable for this study. The researchers aim to determine if this combination can kill more tumor cells than the current treatment alone. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot receive any other chemotherapy, immunotherapy, or biologic therapy for cancer treatment while participating in this study.

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

Research has shown that cemiplimab is generally well-tolerated and has produced promising results when combined with other treatments. Studies have demonstrated that combining ramucirumab and docetaxel can extend the lives of patients with lung cancer. These treatments are considered safe, though they may cause side effects such as tiredness, low blood cell counts, and nausea.

Cemiplimab aids the immune system in identifying and attacking cancer cells. While it can cause side effects like tiredness, rash, or diarrhea, it has been used safely in similar contexts. Ongoing studies aim to better understand how adding cemiplimab to docetaxel and ramucirumab can enhance treatment outcomes and assess its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Cemiplimab is unique because it leverages a novel mechanism by targeting the PD-1 pathway, which plays a crucial role in helping the immune system recognize and attack cancer cells. Unlike standard treatments for non-small cell lung cancer, such as chemotherapy, which broadly attack both cancerous and healthy cells, cemiplimab offers a more targeted approach, potentially reducing damage to normal cells and improving overall patient outcomes. Researchers are excited about cemiplimab because of its promise to enhance the effectiveness of existing therapies like docetaxel and ramucirumab, potentially leading to better control of the disease and improved survival rates.

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

This trial will compare two treatment approaches for non-small cell lung cancer. In one arm, participants will receive a combination of ramucirumab and docetaxel. Studies have shown that this combination improves patient survival and delays cancer growth. In the other arm, participants will receive cemiplimab in addition to ramucirumab and docetaxel. Cemiplimab aids the immune system by blocking a pathway that cancer cells use to hide, making it easier for the immune system to find and attack the cancer. Studies suggest that adding cemiplimab to the usual treatment with docetaxel and ramucirumab might be more effective for treating non-small cell lung cancer. ^{1 2 3 4 5}

Who Is on the Research Team?

Saiama N Waqar

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for adults with advanced non-small cell lung cancer (stage IV or recurrent) who have previously been treated with platinum chemotherapy and immunotherapy. They must have shown disease progression after these treatments, had a positive response to prior PD-1 or PD-L1 therapy, and recovered from any major side effects of previous cancer treatments.

Inclusion Criteria

Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC) as determined by the LUNGMAP protocol

Participants must not have had certain immune-mediated adverse events

Participants must not be pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dexamethasone, ramucirumab, and docetaxel with or without cemiplimab in 21-day cycles

21-day cycles, repeated until disease progression or unacceptable toxicity

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3-6 months for up to 3 years

Regular visits every 3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• Docetaxel
• Ramucirumab

Trial Overview The study tests if adding Cemiplimab, an immune system booster that blocks the PD-1 pathway used by tumors to avoid immune attacks, improves outcomes when combined with standard treatment Docetaxel and Ramucirumab. The latter two drugs inhibit tumor growth directly and by cutting off their blood supply.

How Is the Trial Designed?

Group I: Arm II (cemiplimab, ramucirumab, docetaxel) Experimental Treatment 7 Interventions

Patients receive dexamethasone PO BID on days 0-2, ramucirumab IV over 30-60 minutes on day 1, docetaxel IV over 60 minutes on day 1, and cemiplimab IV over 30 minutes on day 1 of each cycle (each cycle is 21 days). Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and CT or MRI throughout the study.

Group II: Arm I (ramucirumab, docetaxel) Active Control 6 Interventions

Patients receive dexamethasone PO BID on days 0-2, ramucirumab IV over 30-60 minutes on day 1 and docetaxel IV over 60 minutes on day 1 of each cycle (each cycle is 21 days). Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and CT or MRI throughout the study.

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

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

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10507469/

Clinical outcomes of ramucirumab plus docetaxel in the ... In the REVEL trial, ramucirumab plus docetaxel demonstrated significant improvements in overall survival (OS), progression-free survival ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06616584

Study Details | NCT06616584 | Adding the Immunotherapy ... This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab ...

3. yalemedicine.org yalemedicine.org/clinical-trials/s1800e-a-randomized-phase-ii-iii-study-of-docetaxel-and-ramucirumab-with-or-without-cemiplimab-re

A Randomized Phase II/III Study of Docetaxel and ... Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06444

Adding the Immunotherapy Drug Cemiplimab to Usual ... This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab ...

5. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/13559/a-randomized-phase-iiiii-6/

A Randomized Phase Ii/Iii Study of Docetaxel and This study investigates the effects of adding an investigational medication, cemiplimab, to the usual treatment of docetaxel and ramucirumab for ...