BridgeMD
New treatment option for Malignant Neoplasm
Official title KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)
ClinicalTrials.gov ID: NCT07252739
What this study is testing
What is MK-1084?
MK-1084 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malignant neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers want to learn if using a study medicine called MK-1084 can help treat NSCLC. MK-1084 is a type of treatment called targeted therapy for the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C gene change.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main include but are not limited to the following:
- Has histologically or cytologically confirmed diagnosis of advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC)
- Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog...
- Can provide an archival tumor tissue sample or newly obtained core, incisional, excisional biopsy of a tumor lesion not previously irradiated
- Has recovered to ≤Grade 1 or baseline from any Adverse events (AEs) due to previous anticancer therapies and/or ≤Grade 2 neuropathy and/or...
You likely can't join if
- The main exclusion criteria include but are not limited to the following:
- Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Has HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- Has uncontrolled, clinically significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV...
- Has received prior systemic anticancer therapy for advanced or metastatic NSCLC
See the full eligibility criteria
- The main include but are not limited to the following:
- Has histologically or cytologically confirmed diagnosis of advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC)
- Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutations
- Can provide an archival tumor tissue sample or newly obtained core, incisional, excisional biopsy of a tumor lesion not previously irradiated
- Has recovered to ≤Grade 1 or baseline from any Adverse events (AEs) due to previous anticancer therapies and/or ≤Grade 2 neuropathy and/or endocrine-related AEs adequately treated with hormone replacement
- Has well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) if HIV-infected
- Has undetectable hepatitis B (HBV) viral load and have received HBV antiviral therapy for at least 4 weeks if hepatitis B surface antigen (HBsAg) positive
- Has undetectable hepatitis C (HCV) viral load if HCV-infected
- The main exclusion criteria include but are not limited to the following:
- Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Has HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- Has uncontrolled, clinically significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction...
- Has received prior systemic anticancer therapy for advanced or metastatic NSCLC
- Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE) (except endocrine disorders that can be treated with replacement therapy) or...
- Has received previous treatment with an agent targeting KRAS
- Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from AE associated with anticancer therapy before...
- Has received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the...
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has a known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has a history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
The study team makes the final eligibility decision.
Where it's taking place
- Clermont, Florida, United States
- Fargo, North Dakota, United States
- Sioux Falls, South Dakota, United States
- Santiago, Region M. de Santiago, Chile
- Nanjing, Jiangsu, China
- Chengdu, Sichuan, China
- Kuopio, Northern Savonia, Finland
- Vaasa, Pohjanmaa, Finland
- Turku, Southwest Finland, Finland
- Helsinki, Uusimaa, Finland
- Central, Hong Kong
- Kowloon, Hong Kong
- Pokfulam, Hong Kong
- Milan, Lombardy, Italy
- Deventer, Overijssel, Netherlands
- Leiden, South Holland, Netherlands
- Seoul, South Korea
- Seville, Spain
- Bangkok, Bangkok, Thailand
- Talas, Kayseri, Turkey (Türkiye)
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont, Florida, United States; Fargo, North Dakota, United States; Sioux Falls, South Dakota, United States; Santiago, Region M. de Santiago, Chile; Nanjing, Jiangsu, China; Chengdu, Sichuan, China and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.