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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

Study Summary

This trial is testing whether post-operative chemotherapy is better than radiographic surveillance for stage I or stage IIA non-small cell lung cancer patients.

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.Check my eligibility

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.See study design

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

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

Primary outcome measures

Disease-Free Survival

Secondary outcome measures

Overall Survival

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

Find a Location

Who is running the clinical trial?

Encore ClinicalOTHER

Razor GenomicsLead Sponsor

David R Spigel, MDPrincipal InvestigatorSarah Cannon, The Cancer Institute of HCA Healthcare

8 Previous Clinical Trials

468 Total Patients Enrolled

Media Library

Observation Clinical Trial Eligibility Overview. Trial Name: NCT01817192 — N/A

Non-Small Cell Lung Cancer Research Study Groups: Observation, Adjuvant Chemotherapy

Non-Small Cell Lung Cancer Clinical Trial 2023: Observation Highlights & Side Effects. Trial Name: NCT01817192 — N/A

Observation 2023 Treatment Timeline for Medical Study. Trial Name: NCT01817192 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there various venues where this experiment is being conducted in the state?

"Allegheny Health Network Research Institute in Pittsburgh, Pennsylvania, Mercy Oncology Research St. Louis in Saint Louis, Missouri and Highlands Oncology Group in Springdale, Arkansas are all participating sites for this research trial; 20 other medical centres have been recruited as well."

Answered by AI

Is there any remaining availability to join this medical experiment?

"This experiment, first introduced on the 11th of September 2020 and updated most recently on the 1st November 2022, is presently seeking new participants according to data available on clinicaltrials.gov."

Answered by AI

What is the current sample size of individuals participating in this clinical trial?

"The sponsor, Razor Genomics, has identified a need for 1050 participants that meet the study's eligibility requirements. The trial will operate out of Allegheny Health Network Research Institute in Pittsburgh and Mercy Oncology Research St. Louis within Missouri."

Answered by AI