Study on MK-1084 and Other Treatments for Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT07190248
This clinical trial is exploring whether the combination of MK-1084 and pembrolizumab, given as an injection under the skin, can effectively treat non-small cell lung cancer (NSCLC) by helping patients live longer without the cancer growing or spreading, compared to pembrolizumab with chemotherapy.
Patient Parameters
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Program Overview
The purpose of this study is to determine if using the study drug MK-1084 together with pembrolizumab, both given as injections, can help treat non-small cell lung cancer (NSCLC) more effectively than the standard treatment of pembrolizumab with chemotherapy. MK-1084 is a targeted therapy specifically for cancers with the KRAS G12C mutation. Researchers aim to find out if this combination can help patients live longer without their cancer getting worse.
Eligibility Criteria
Inclusion Criteria
- Have non-squamous non-small cell lung cancer (NSCLC) that is either Stage IIIB or IIIC and cannot be removed by surgery or treated with chemoradiation, or Stage IV with cancer spread to other parts of the body.
- If HIV positive, must have well-controlled HIV with antiretroviral therapy (ART).
Exclusion Criteria
- Have small cell lung cancer or a mix of tumors with small cell elements.
- Have active inflammatory bowel disease needing immunosuppressive medication or a history of such conditions like Crohn's disease or ulcerative colitis.
- Have uncontrolled significant heart or blood vessel disease.
- Have a digestive disorder affecting absorption.
- Are HIV positive with a history of Kaposi's sarcoma or Multicentric Castleman's Disease.
- Have received previous systemic cancer treatment for advanced or metastatic NSCLC.
- Have another progressing cancer or one that needed treatment in the last 3 years.
- Have active cancer spread to the brain or spinal cord or have cancerous meningitis.
- Have an active autoimmune disease needing treatment in the last 2 years.
- Have a history of lung inflammation needing steroids or currently have lung inflammation.
- Have an active infection needing treatment, except those specified by the study.
- Have a history of stem cell or organ transplant.
- Have not fully recovered from major surgery or have ongoing surgical complications.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mount Sinai Cancer Center ( Site 0137) | 33140 | Miami Beach | Florida |
| New York Oncology Hematology, P.C. ( Site 0119) | 12206 | Albany | New York |
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