What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC), particularly those involving post-operative chemotherapy for high-risk patients, often include cisplatin-based doublets. The known side effects of these chemotherapy regimens can include nausea, vomiting, fatigue, hair loss, increased risk of infection due to low white blood cell counts, kidney damage, hearing loss, and neuropathy (numbness or tingling in the hands and feet). These side effects vary in severity among patients and should be managed under the guidance of a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC), particularly focusing on targeted therapies and immunotherapies. For instance, sotorasib and adagrasib have been approved for patients with KRAS G12C-mutated NSCLC who have received prior systemic therapy. Additionally, nivolumab, an anti-PD-1 therapy, has been approved for use after progression following chemotherapy. These treatments are relevant to the context of the 14-Gene Prognostic Assay, which aims to identify high-risk patients who might benefit from targeted post-operative chemotherapy.

What other types of research exist?

Promising novel alternatives to the 14-Gene Prognostic Assay for NSCLC patients include gene expression profiling, KRAS mutation status, and p53 overexpression. Gene expression profiling can help define prognostic subsets, while KRAS and p53 abnormalities have been associated with differential responses to adjuvant chemotherapy. These biomarkers are under investigation and may offer additional predictive value for treatment decisions.

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Adjuvant Chemotherapy for Non-Small Cell Lung Cancer

N/A

Recruiting

Led By David R Spigel, MD

Research Sponsored by Razor Genomics

Eligibility Criteria Checklist

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

Must have

Life expectancy excluding NSCLC diagnosis ≥ 5 years

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a test that examines 14 genes to predict if early-stage lung cancer will return or spread after surgery. It targets patients with Stage I or Stage IIA non-small cell lung cancer who are at high risk. The test helps doctors decide if additional treatment like chemotherapy is needed.

Who is the study for?

This trial is for adults who've had surgery to remove Stage I or IIA non-squamous NSCLC and are at high risk of the cancer returning. They must be able to undergo chemotherapy, have a life expectancy of over 5 years excluding their lung cancer diagnosis, and be in good physical condition with fully healed surgical incisions.

What is being tested?

The study is testing if post-operative adjuvant chemotherapy can improve survival compared to just watching patients with radiographic surveillance after surgery. It uses a new tool called the 14-Gene Prognostic Assay to identify those at higher risk of death within five years from lung cancer.

What are the potential side effects?

Adjuvant chemotherapy can cause side effects like nausea, fatigue, hair loss, increased infection risk due to lowered immunity, nerve damage leading to numbness or tingling sensations, and may affect blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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Excluding my lung cancer, my health suggests I could live 5 more years.

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I am 18 years old or older.

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I am open to being assigned to receive chemotherapy as part of the study.

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My surgical wounds have fully healed.

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My early-stage lung cancer was completely removed by surgery.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Disease-Free Survival

Secondary study objectives

Overall Survival

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: ObservationActive Control2 Interventions

Post-operative observation of Stage I or Stage IIA non squamous non-small cell lunger cancer with Radiographic Surveillance is a current standard of care. Patients identified as low risk will be observation. Those patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Adjuvant Chemotherapy Arm.

Group II: Adjuvant ChemotherapyActive Control2 Interventions

Adjuvant Chemotherapy is a current standard of care for intermediate or high-risk Stage I or Stage IIA non-squamous non-small cell lung cancer. Patients identified as intermediate or high-risk by the 14-Gene Prognostic Assay will be randomized either to this arm or the Observation Arm.

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 chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cancer cells but can also affect normal cells, leading to side effects. Targeted therapy, such as EGFR inhibitors, focuses on specific genetic mutations in cancer cells, reducing harm to normal cells. Immunotherapy, including PD-1/PD-L1 inhibitors, enhances the immune system's ability to recognize and destroy cancer cells. These treatments are particularly important for NSCLC patients identified as high-risk by tools like the 14-Gene Prognostic Assay, as they can improve survival rates and minimize unnecessary side effects by tailoring therapy to individual genetic profiles and risk factors.

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