140 Participants NeededMy employer runs this trial

MK-1084 for Lung Cancer

Recruiting at 28 trial locations
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No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

MD

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

My HIV is well-controlled with antiretroviral therapy.
I have been diagnosed with advanced or metastatic non-squamous NSCLC.
My cancer got worse after 1-2 treatments with PD-1/PD-L1 drugs and platinum chemo.
See 3 more

Exclusion Criteria

I have another cancer that is growing or was treated in the last 3 years.
I am still recovering from major surgery or have ongoing surgical complications.
I have serious lung problems from other lung illnesses.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-1084 in combination with other agents until discontinuation due to toxicity, AE, or at the discretion of an investigator

Up to 42 days for initial DLT evaluation, then ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 65 months

Long-term follow-up

Participants are monitored for progression-free survival and other outcomes

Up to approximately 124 months

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

Group I: MK-1084 + Sacituzumab tirumotecan (Sac-TMT)Experimental Treatment3 Interventions
Group II: MK-1084 + Patritumab deruxtecan (HER3-DXd)Experimental Treatment3 Interventions
Group III: MK-1084 + CetuximabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

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 ...

Investigational 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.