What is the mechanism of action of this treatment?

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies, such as EGFR inhibitors, ALK inhibitors, and MET inhibitors, work by blocking specific proteins and pathways that are essential for cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors, boost the immune system's ability to recognize and destroy cancer cells. These treatments are significant for NSCLC patients because they offer more personalized and effective options, often with fewer side effects compared to conventional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) that involve targeted therapies or novel agents, such as MET inhibitors (e.g., capmatinib), often have side effects including peripheral edema, nausea, increased creatinine levels, and vomiting. Other targeted therapies, like those inhibiting PD-1/PD-L1 pathways (e.g., pembrolizumab), can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy agents used in NSCLC, such as cisplatin and carboplatin, are associated with side effects like nephrotoxicity, neurotoxicity, myelosuppression, and gastrointestinal disturbances.

What prior FDA approvals exist?

Several targeted therapies and novel agents have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Sotorasib and adagrasib are approved for patients with KRAS G12C-mutated NSCLC, targeting the KRAS G12C mutation. Capmatinib and tepotinib are approved for NSCLC with MET exon-14-skipping mutations, targeting the MET protein. These drugs are designed to interfere with specific pathways or proteins involved in cancer progression, similar to the likely focus of the MGY825 trial.

What other types of research exist?

Promising novel alternatives to MGY825 for NSCLC patients include GSK3052230, an FGFR pathway inhibitor, which has shown a median progression-free survival of 5.5 months in combination with chemotherapy. Additionally, immune checkpoint inhibitors like pembrolizumab, which have been approved for advanced NSCLC with PD-L1 expression, continue to be a viable option. Anlotinib, a small-molecule TKI, has also shown progression-free survival benefits in phase II studies. These therapies represent some of the latest advancements in the treatment of NSCLC.

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Monoclonal Antibodies

MGY825 for Lung Cancer

Phase 1

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically or cytologically confirmed diagnosis of advanced (metastatic or unresectable) NFE2L2/KEAP1/CUL3 mutant NSCLC. Local data confirming the NFE2L2/KEAP1/CUL3 mutation status in tissue must be available for enrollment.

Patients must have progressed after 1 platinum-based chemotherapy regimen and PD-(L)1 antibody therapy either sequentially or concurrent with chemotherapy, where indicated, for Stage IV NSCLC.

Must not have

Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥2), uncontrolled hypertension or clinically significant arrhythmia.

QTcF > 470 msec on screening ECG or congenital long QT syndrome. Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called MGY825 in adult patients with advanced lung cancer. It focuses on those with certain genetic mutations to see if the drug is safe and effective in shrinking tumors.

Who is the study for?

Adults with advanced non-small cell lung cancer who've had one platinum-based chemo and PD-(L)1 therapy, but the cancer has progressed. They must be able to undergo a biopsy, have certain mutations (NFE2L2/KEAP1/CUL3), and measurable lesions. Excluded if they have serious heart issues, uncontrolled blood pressure, recent heart attack or angina, can't swallow capsules, untreated brain metastases requiring steroids or treatment within 4 weeks before the trial.

What is being tested?

The study is testing MGY825 as a single agent in patients with advanced non-small cell lung cancer. Participants will receive this experimental medication to see how effective it is against their cancer after previous treatments have failed.

What are the potential side effects?

While specific side effects of MGY825 are not listed here, common side effects for similar treatments may include fatigue, nausea, diarrhea, skin reactions and potential liver enzyme elevations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is advanced, cannot be surgically removed, and has specific genetic mutations.

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My Stage IV NSCLC worsened after platinum-based chemo and PD-(L)1 therapy.

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My lung cancer is advanced and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart conditions like uncontrolled high blood pressure or heart failure.

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I have a heart condition with a long QT interval or had a recent heart attack.

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I currently have an active COVID-19 infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose intensity

Frequency of dose interruptions and reductions

Incidence and nature of dose limiting toxicities (DLTs) during the first 28 days of treatment with the study drug

+1 more

Secondary study objectives

Area under the concentration-time curve (AUC)

Duration of response (DOR) per RECIST 1.1

Heart rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose expansion group 2Experimental Treatment1 Intervention

Patients with advanced NSCLC irrespective of prior knowledge of NFE2L2/KEAP1/CUL3 mutational status.

Group II: Dose expansion group 1Experimental Treatment1 Intervention

Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status

Group III: Dose escalationExperimental Treatment1 Intervention

Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies, such as EGFR inhibitors, ALK inhibitors, and MET inhibitors, work by blocking specific proteins and pathways that are essential for cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors, boost the immune system's ability to recognize and destroy cancer cells. These treatments are significant for NSCLC patients because they offer more personalized and effective options, often with fewer side effects compared to conventional chemotherapy.

Emerging therapeutic agents for lung cancer.Systemic therapy for lung cancer brain metastases: a rationale for clinical trials.