Cemiplimab for Non-Small Cell Lung Cancer

Recruiting at 79 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

Trial Summary

What is the purpose of this trial?

This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.

Research Team

Saiama N Waqar

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+