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)
KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests MK-1084 with pembrolizumab for advanced non-small cell lung cancer with a KRAS G12C gene change. MK-1084 targets this gene change. Researchers will check its safety and see how often the cancer shrinks or goes away.
Researchers want to learn if using a study medicine called MK-1084 can help treat Non-Small Cell Lung Cancer (NSCLC). MK-1084 is a type of treatment called targeted therapy for the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C gene change. The goal of this study is to learn about the safety of MK-1084 and to learn how many people have the cancer get smaller or go away during the study treatment.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have advanced or spreading nonsquamous non-small cell lung cancer, confirmed by testing cells or tissue.
- Have a KRAS G12C gene change found in a tumor sample or tumor DNA in the blood.
- Can give a stored or new tumor sample from an area not treated with radiation.
- Have mostly recovered from side effects of past cancer treatment. Some nerve damage or hormone problems controlled with replacement hormones are allowed.
- If you have HIV, it must be well controlled with HIV medicine.
- If you test positive for hepatitis B surface antigen, have no detectable virus and have taken antiviral medicine for at least 4 weeks.
- If you have hepatitis C, have no detectable virus.
Who can't join
- Have small cell lung cancer, including a tumor that has some small cell cancer.
- Have had whole-body cancer treatment for advanced or spreading non-small cell lung cancer, or any treatment targeting KRAS.
- Stopped past immune therapy because of certain serious side effects, or had more than 30 Gray of radiation to the lung in the past 6 months. Gray is a measure of radiation dose.
- Have certain severe eye problems, a history of inflammatory bowel disease, or serious uncontrolled heart or blood vessel disease.
- Have a weak immune system, recently took certain medicines that weaken it, or had an autoimmune disease needing whole-body treatment in the past 2 years. Replacement hormones are allowed.
- Have another cancer that is growing or needed treatment in the past 3 years, active cancer spread to the brain or spinal cord, or cancer in their lining.
- Have current or suspected lung inflammation, or past lung inflammation not caused by infection that needed steroids.
- Have had a stem cell or organ transplant, have not healed enough after major surgery, or have HIV with a history of Kaposi’s sarcoma or multicentric Castleman’s disease.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: The main inclusion criteria 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 Exclusion Criteria: 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 history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * 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, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to \>470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention * 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 was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis * 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 allocation/randomization * 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 first dose of study intervention * 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 (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening * Has a history of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications
Study sites (3)
FL
- Clermont Oncology Center ( Site 0041) · Clermont, FL 34711Study Coordinator · Study contact · 386-538-3169More trials in Clermont
ND
- Sanford Health Roger Maris Cancer Center ( Site 0039) · Fargo, ND 58102Study Coordinator · Study contact · 701-234-2000More trials in Fargo
SD
- Sanford Cancer Center Oncology Clinic ( Site 0038) · Sioux Falls, SD 57104Study Coordinator · Study contact · 605-328-8000More trials in Sioux Falls