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New treatment option for Lung Neoplasm Malignant
Official title A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
ClinicalTrials.gov ID: NCT07286149
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 lung neoplasm malignant.
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 MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread.
- 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 non-squamous 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 (KRAS)...
- Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1)...
- Provides archival tumor tissue sample of a tumor lesion not previously irradiated
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 clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has evidence of any leptomeningeal disease
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 non-squamous 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 (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations
- Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy and platinum-based chemotherapy
- Provides archival tumor tissue sample of a tumor lesion not previously irradiated
- Has provided tissue prior to treatment allocation/randomization from a newly obtained biopsy of a tumor lesion not previously irradiated
- Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol
- 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 clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has evidence of any leptomeningeal disease
- Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization
- Has one or more of the following ophthalmological conditions: a) Clinically significant corneal disease b) history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received previous treatment with an agent targeting KRAS
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
- Has an active infection requiring systemic therapy
- Have not adequately recovered from major surgery or have ongoing surgical complications
The study team makes the final eligibility decision.
Where it's taking place
- Clermont, Florida, United States
- Chicago, Illinois, United States
- Portland, Oregon, United States
- Porto Alegre, Rio Grande do Sul, Brazil
- Barretos, São Paulo, Brazil
- São José do Rio Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Santiago, Region M. de Santiago, Chile
- Guangzhou, Guangdong, China
- Athens, Attica, Greece
- Hong Kong, Hong Kong
- Jordan, Hong Kong
- Shatin, Hong Kong
- Jerusalem, Israel
- Ramat Gan, Israel
- Meldola, Forli-Cesena, Italy
- Seoul, South Korea
- Hospitalet, Barcelona, Spain
- Barcelona, Spain
- Seville, Spain
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; Chicago, Illinois, United States; Portland, Oregon, United States; Porto Alegre, Rio Grande do Sul, Brazil; Barretos, São Paulo, Brazil; São José do Rio Preto, São Paulo, Brazil and 14 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.