MK-1084 for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called MK-1084 for individuals with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Researchers aim to determine if MK-1084, combined with other drugs, can safely shrink or eliminate tumors. The study examines the cancer's response to MK-1084 when paired with treatments like cetuximab, sacituzumab govitecan, or patritumab deruxtecan. Suitable participants have NSCLC with a specific KRAS mutation, have tried 1-2 other treatments, and have experienced cancer progression. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or steroids, you may need to stop them 7 days before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies combining MK-1084 with cetuximab demonstrated a manageable safety profile, meaning most side effects were mild and treatable. Patients with advanced cancers, including lung cancer, tolerated this combination well.
For MK-1084 and sacituzumab tirumotecan (sac-TMT), past research on sac-TMT has shown it is generally safe when combined with other cancer drugs. This suggests it might also be well-tolerated with MK-1084, although specific safety data for this exact combination is not yet available.
Regarding MK-1084 combined with patritumab deruxtecan, studies have shown that patritumab deruxtecan is safe for lung cancer patients and has manageable side effects when used with other treatments. This provides some confidence in its safety when combined with MK-1084, but further research is needed for confirmation.
Overall, studies suggest these combinations are generally safe, but discussing individual implications with a doctor is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about MK-1084 for lung cancer because it works differently than standard therapies like chemotherapy and targeted drugs. Unlike traditional treatments, MK-1084 is combined with innovative agents like Cetuximab, Sacituzumab tirumotecan (Sac-TMT), and Patritumab deruxtecan (HER3-DXd), each targeting different cancer pathways. These combinations aim to attack cancer cells more precisely and effectively, potentially leading to better outcomes and fewer side effects. This approach could offer new hope for patients, especially those who have not responded well to existing treatments.
What evidence suggests that this trial's treatments could be effective for advanced or metastatic non-squamous NSCLC?
Research has shown that MK-1084 holds promise for treating non-small cell lung cancer (NSCLC). In this trial, participants may receive MK-1084 combined with cetuximab, which has shrunk tumors in nearly half of the patients, achieving a 46% response rate, and is generally safe. Another treatment option in this trial is MK-1084 combined with sacituzumab tirumotecan (Sac-TMT), which has improved outcomes when used with other therapies, helping 84.2% of patients avoid cancer progression for at least six months. Additionally, MK-1084 combined with patritumab deruxtecan (HER3-DXd) has effectively overcome resistance to treatment in some lung cancer types, allowing patients to live longer without their cancer worsening. Each of these treatment combinations offers potential benefits for advanced NSCLC.12356
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have a specific KRAS G12C mutation and whose cancer got worse after 1-2 prior treatments, including immunotherapy and platinum chemo. Participants must provide tumor samples and be in generally stable health.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MK-1084 in combination with other agents until discontinuation due to toxicity, AE, or at the discretion of an investigator
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- MK-1084
Trial Overview
The study tests MK-1084, a targeted therapy, alone or combined with other drugs like Cetuximab, Sacituzumab tirumotecan, or Patritumab deruxtecan to see if these combinations help shrink the cancer. The focus is on safety and how well people tolerate these treatments.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants will receive MK-1084 and sac-TMT until discontinuation due to toxicity, AE or at the discretion of an investigator.
Participants will receive MK-1084 and HER3-DXd until discontinuation due to toxicity, adverse event (AE) or at the discretion of an investigator.
Participants will receive MK-1084 and cetuximab until discontinuation due to toxicity, AE or at the discretion of an investigator. Per amendment 3, the MK-1084 + Cetuximab arm was discontinued.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Daiichi Sankyo
Industry Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
Citations
The KRAS G12C inhibitor MK-1084 for ...
Here, we report data for MK-1084 monotherapy, MK-1084 + cetuximab, and MK-1084 + cetuximab + mFOLFOX6 in pts with advanced KRAS G12C-mutant CRC.
Merck Announces MK-1084, an Investigational KRAS ...
In patients with advanced KRAS G12C-mutated CRC and NSCLC, a manageable safety profile and antitumor activity were observed with MK-1084 either ...
3.
appliedclinicaltrialsonline.com
appliedclinicaltrialsonline.com/view/investigational-mk-1084-demonstrates-antitumor-activity-trial-colorectal-non-small-cell-lung-cancersInvestigational MK-1084 Demonstrates Antitumor Activity in ...
MK-1084, Merck's investigational KRAS G12C inhibitor, showed a manageable safety profile along with antitumor activity in the Phase I KANDLELIT-001 study.
Current status of KRAS G12C inhibitors in NSCLC and the ...
In NSCLC patients, first-line combination therapy achieved an ORR of 64.7% and a DCR of 93.1%, with a median PFS of 12.2 months in 102 patients ...
NCT06997497 | A Clinical Study of Calderasib (MK-1084) ...
Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation.
A Study of Pembrolizumab Plus MK-1084 in Participants ...
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.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.