Study Comparing Subcutaneous and Intravenous Pembrolizumab for Treating Metastatic Non-small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT05722015
This clinical trial is testing a new way of giving the cancer drug pembrolizumab, either as a shot under the skin or through an IV, to see if it works as well and is as safe as the traditional method for treating adults with metastatic non-small cell lung cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to compare two methods of administering pembrolizumab, a cancer treatment, in combination with chemotherapy for adults with metastatic non-small cell lung cancer (NSCLC). Researchers want to find out if giving pembrolizumab as a subcutaneous injection (under the skin) with berahyaluronidase alfa is as effective and safe as the standard intravenous (IV) method.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with either squamous or non-squamous non-small cell lung cancer (NSCLC).
- Able to provide a sample of tumor tissue, either from a previous biopsy or a new one.
- Expected to live for at least 3 more months.
Exclusion Criteria
- Diagnosed with small cell lung cancer or a mix of small cell and non-small cell lung cancer.
- Previously treated with systemic cancer therapy for metastatic NSCLC.
- Received any cancer treatment, including experimental drugs, within 4 weeks before joining the study.
- Had radiation therapy within 2 weeks before starting the study treatment or has side effects from radiation that need steroid treatment.
- Had radiation therapy to the lung (more than 30 Gray) within 6 months before starting the study treatment.
- Received a live vaccine within 30 days before the first dose of the study treatment.
- Diagnosed with an immune system deficiency or taking long-term steroid medication.
- Has another cancer that is getting worse or needed treatment in the last 3 years.
- Has an active autoimmune disease needing treatment in the last 2 years.
- Has an active infection needing treatment.
- Has a history of HIV infection.
- Has a history of Hepatitis B or C.
- Has not fully recovered from major surgery or has ongoing surgical issues.
- Has had a tissue or organ transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023) | 85004 | Phoenix | Arizona |
| Clermont Oncology Center ( Site 0018) | 34711 | Clermont | Florida |
| Mid Florida Hematology and Oncology Center ( Site 0010) | 32763 | Orange City | Florida |
| University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022) | 60612 | Chicago | Illinois |
| Orchard Healthcare Research Inc. ( Site 0011) | 60077 | Skokie | Illinois |
| Franciscan Health Lafayette East ( Site 0020) | 47905 | Lafayette | Indiana |
| Mercy Health-Paducah Cancer Center ( Site 0006) | 42003 | Paducah | Kentucky |
| Hattiesburg Clinic Hematology/Oncology ( Site 0008) | 39401 | Hattiesburg | Mississippi |
| Central Care Cancer Center - Bolivar ( Site 0017) | 65613 | Bolivar | Missouri |
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