What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy agents like carboplatin, paclitaxel, and etoposide often cause side effects such as fatigue, nausea, hair loss, and increased risk of infection. Immunotherapy drugs, such as pembrolizumab and atezolizumab, can lead to immune-related adverse events including skin rash, colitis, and pneumonitis. Targeted therapies, which may include tyrosine kinase inhibitors, can cause side effects like diarrhea, liver function abnormalities, and hypertension. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab, an anti-PD-1 antibody, is approved for use in combination with chemotherapy for advanced squamous NSCLC, showing improved overall survival and progression-free survival. Nivolumab, another anti-PD-1 antibody, is approved for use after progression on platinum-based chemotherapy. Additionally, fam-trastuzumab deruxtecan, a HER2-targeted antibody-drug conjugate, is approved for patients with HER2-mutant NSCLC who have received prior systemic therapy. These treatments highlight the shift towards targeted and immunotherapy approaches in NSCLC management.

What other types of research exist?

Promising novel alternatives for NSCLC patients include: 1) LY01008 combined with paclitaxel/carboplatin, which has demonstrated similarity to Avastin in terms of efficacy and safety. 2) Pembrolizumab, a PD-1 inhibitor, which has shown benefits in patients with advanced NSCLC, particularly those with PD-L1 expression. 3) Nivolumab, another PD-1 inhibitor, which has been beneficial in pretreated, advanced NSCLC patients. These treatments are expected to be viable options in 2024.

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Small Molecule Inhibitor

VMD-928 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by VM Oncology, LLC

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma that is not responsive to standard therapies or had progressed following standard therapy and for which there is no approved or curative therapy

ECOG score of 0 or 1

Must not have

Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C)

Patients with a history of chronic viral hepatitis (HBV/HCV) or a history of cirrhotic liver secondary to any etiology (i.e. alcoholism, non-alcoholic steatohepatitis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests VMD-928, an oral drug, in adults with advanced cancers that don't respond to other treatments. It aims to find a safe and effective dose and understand how the drug affects cancer cells.

Who is the study for?

Adults with advanced solid tumors or lymphoma that have no standard curative therapy left. They must have TrkA overexpression, NTRK1 gene fusion, or progression after pan-Trk inhibitor treatment. Participants need to be in good physical condition (ECOG score of 0-1), able to take oral meds, and provide tumor tissue for analysis.

What is being tested?

The trial is testing VMD-928, an oral medication aimed at treating various cancers by targeting the TrkA protein. It's a Phase 1 study where all participants receive the drug to evaluate its safety and effectiveness against their cancer.

What are the potential side effects?

Specific side effects are not listed here but may include typical reactions related to anticancer medications such as nausea, fatigue, liver issues, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is not responding to standard treatments or has worsened after them.

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I am fully active or can carry out light work.

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I can take pills and keep them down.

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My tumor shows high TrkA protein levels, has NTRK1 gene changes, or grew after Trk treatment.

Exclusion Criteria

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

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I have not had chemotherapy that causes delayed side effects in the last 14 days.

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I have a history of chronic hepatitis or liver cirrhosis due to any cause.

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My heart, liver, kidneys, or lungs are stable and won't affect my safety in the trial.

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I haven't had cancer treatment like radiation or surgery in the last 2 weeks.

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I do not have any mental health or personal issues that would stop me from following the study's requirements.

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I haven't taken any experimental cancer drugs within the last 14 days or 5 half-lives before starting VMD-928.

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I do not have any active infections, including HIV.

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My heart condition significantly limits my physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: VMD-928 300 mg Tablet (ongoing); 100 mg Capsule (complete)Experimental Treatment1 Intervention

0 / 12Eligibility 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 tyrosine kinase inhibitors, block specific proteins that promote cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors, boost the immune system's ability to detect and kill cancer cells. These treatments are significant for NSCLC patients as they provide more personalized and effective options, often leading to improved outcomes and reduced side effects compared to conventional chemotherapy.

Emerging therapeutic agents for lung cancer.Management of patients with lung cancer and poor performance status.