Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)

Conditions

• Recurrent Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Cemiplimab — BIOLOGICAL
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT
• Dexamethasone — DRUG
  Given PO
• Docetaxel — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Ramucirumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

May 22, 2025

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

378 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (ramucirumab, docetaxel)
  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.
• Experimental: Arm II (cemiplimab, ramucirumab, docetaxel)
  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.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From date of randomization to date of death due to any cause, assessed up to 3 years ]

Central Contacts

• Jennifer Beeler
  210-614-8808
  [email protected]
• SWOG Network Operations Center
  [email protected]

Locations (386)

Find similar trials in Daphne, AL

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