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Precision Medicine

Personalized Treatment Planning for Non-Small Cell Lung Cancer (PRiMAL Trial)

N/A

Recruiting

Led By Jill Kolesar, PharmD, MS

Research Sponsored by Jill M Kolesar

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks, 12 weeks, and 1 year

Awards & highlights

PRiMAL Trial Summary

This trial will compare Molecular Tumor Board (MTB) assisted care to usual care for patients who have newly diagnosed NSCLC. MTB uses a team of specialists to develop a personalized treatment plan for each patient.

Who is the study for?

This trial is for adults with stage IIb-IV Non-Small Cell Lung Cancer (NSCLC) who haven't had systemic therapies, except possibly adjuvant therapy for early-stage cancer. They can have had surgery or radiation and must be able to consent to treatment. It's not open to pregnant individuals or those with uncontrolled illnesses that could interfere with the trial.Check my eligibility

What is being tested?

The study is testing if care guided by a Molecular Tumor Board (MTB)—a team of experts analyzing tumor genetics—can improve outcomes compared to usual cancer care in patients preparing for NSCLC treatment.See study design

What are the potential side effects?

Since this trial compares standard care with MTB-assisted care, side effects will vary based on individual treatments chosen. These may include typical cancer treatment side effects like fatigue, nausea, and increased infection risk.

PRiMAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks, 12 weeks, and 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks, 12 weeks, and 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks, 12 weeks, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in quality of life (QOL)

Secondary outcome measures

Change in guideline concordant care

Change in satisfaction with treatment

Overall survival

Other outcome measures

Association of ctDNA variant allele frequency

PRiMAL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Molecular tumor board interventionExperimental Treatment1 Intervention

Group II: Usual care recipientsActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor

2,618 Previous Clinical Trials

3,201,017 Total Patients Enrolled

Jill M KolesarLead Sponsor

3 Previous Clinical Trials

33 Total Patients Enrolled

Jill Kolesar, PharmD, MSPrincipal InvestigatorUniversity of Kentucky

1 Previous Clinical Trials

Media Library

Molecular Tumor Board Assisted Care (Precision Medicine) Clinical Trial Eligibility Overview. Trial Name: NCT05254795 — N/A

Non-Small Cell Lung Cancer Research Study Groups: Usual care recipients, Molecular tumor board intervention

Non-Small Cell Lung Cancer Clinical Trial 2023: Molecular Tumor Board Assisted Care Highlights & Side Effects. Trial Name: NCT05254795 — N/A

Molecular Tumor Board Assisted Care (Precision Medicine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05254795 — N/A

Frequently Asked Questions

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

What is the upper limit of participants included in this clinical experiment?

"Affirmative, the data posted on clinicaltrials.gov indicates that this survey is actively recruiting participants; it was first published on April 13th 2022 and last edited on the same date. This investigation requires 500 individuals to be sourced from a single centre."

Answered by AI

Is the participant eligibility criteria open to those aged 55 or above?

"This clinical trial is enrolling individuals who are at least 18 years of age and no more than 120 years old."

Answered by AI

Is participation in this investigation open to the public?

"This medical study is enrolling 500 individuals ages 18 to 120 that have been confirmed or are clinically suspected of having non-small cell lung carcinoma. To qualify, patients must not have received systemic treatment for the disease prior (with the exception of early stage therapies) and they must demonstrate their capacity to understand and sign a consent form."

Answered by AI

Is there an open enrollment period for this research project?

"Affirmative. Data available on clinicaltrials.gov suggests that this medical experiment is currently seeking participants, with its initial post-date being 4/13/2022 and most recent update occurring the same day. It seeks to enlist 500 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Precision Medicine Randomized Clinical Trial Comparing Molecular Tumor Board Assisted Care to Usual Care

Jill M Kolesar 2022. "Precision Medicine Randomized Clinical Trial Comparing Molecular Tumor Board Assisted Care to Usual Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05254795.