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A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

Short Title: S1800E

Enrollment Status: Recruiting

NCT #: NCT06616584

Specialty Area: Oncology

Condition Studied: Stage IV or Recurrent Non-Small Cell Lung Cancer

Age Groups: Adult; Older Adult

Phase: II/III

Study Information

Summary / Purpose

The purpose of this study is to compare 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).

Study Type: Interventional

Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:

Adults 18+ years of age
Diagnosis of Non-Small Cell Lung Cancer
Must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease
Must have experienced disease progression
No prior therapy with docetaxel for this disease

What's Involved

Participation in the study will include:

Random assignment to receive study treatment by intravenous (IV) infusion on day 1 of each 21-day cycle, either docetaxel and ramucirumab alone or with the immunotherapy drug cemiplimab
Taking dexamethasone by mouth before and after each infusion
Computed tomography (CT) or magnetic resonance imaging (MRI) scans, including a scan of the brain before treatment begins and scans throughout the study to check how the cancer responds
Blood sample collection

Principal Investigator

Katharine Thomas MD, MSc

Oncology

(775) 982–2820

Renown Hematology/Oncology

View Provider

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Complete Study Details: https://clinicaltrials.gov/study/NCT06616584

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.