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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on day 1 and day 15 of cycle 1 (each cycle is 28 days)

Awards & highlights

Study Summary

This trial is testing a new drug for adults with advanced cancer that has not responded to other treatments.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on day 1 and day 15 of cycle 1 (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on day 1 and day 15 of cycle 1 (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 1 and day 15 of cycle 1 (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number and severity of treatment-emergent AEs

Secondary outcome measures

Analgesic response as defined by the Brief Pain Inventory (BPI).

Area under the plasma concentration versus time curve (AUC) of VMD-928.

Change in TrkA protein expression.

+6 more

Trial Design

1Treatment groups

Experimental Treatment

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

0 / 4Eligibility 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.