500 Participants Needed

Personalized Treatment Planning for Non-Small Cell Lung Cancer

(PRiMAL Trial)

JK
TM
Overseen ByTimothy Mullett, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Timothy Mullett
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial will compare Molecular Tumor Board (MTB) assisted care to usual care for patients who have newly diagnosed histologically or cytologically confirmed stage IIb-IV Non-Small Cell Lung Cancer (NSCLC) and are planning to undergo treatment for their cancer.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Molecular Tumor Board Assisted Care for Non-Small Cell Lung Cancer?

Molecular tumor boards (MTBs) help doctors make better treatment decisions for patients with complex cancer cases by providing personalized recommendations based on the patient's unique genetic makeup. Studies show that MTBs improve access to targeted therapies and help avoid unnecessary treatments, which can save costs and reduce side effects.12345

How is Molecular Tumor Board Assisted Care different from other treatments for non-small cell lung cancer?

Molecular Tumor Board Assisted Care is unique because it uses a team of experts to analyze the genetic makeup of a patient's tumor and recommend personalized treatment options. This approach tailors therapy to the individual's specific tumor characteristics, potentially improving outcomes compared to standard treatments that do not consider these unique genetic factors.12567

Research Team

TM

Timothy Mullett, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

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.

Inclusion Criteria

I have not had drug treatments for my lung cancer, except possibly for early stage.
Ability to understand and the willingness to sign a written informed consent document.
My lung cancer is between stages IIb and IV and I am planning treatment.

Exclusion Criteria

I do not have any severe illnesses that my doctor thinks could interfere with the treatment.
Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Molecular Tumor Board assisted care or usual care for their NSCLC

12 weeks
Visits at enrollment, 8 weeks, and 12 weeks

Follow-up

Participants are monitored for overall survival and other outcomes

1 year

Treatment Details

Interventions

  • Molecular Tumor Board Assisted Care
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Molecular tumor board interventionExperimental Treatment1 Intervention
Group II: Usual care recipientsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Timothy Mullett

Lead Sponsor

Trials
2
Recruited
800+

Jill M Kolesar

Lead Sponsor

Trials
4
Recruited
540+

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

The University Medical Center Groningen's molecular tumor board (MTB) effectively recommended targeted therapies for 59 out of 110 non-small-cell lung cancer (NSCLC) cases with complex genomic alterations, leading to a high adherence rate of 81% to these recommendations.
Patients who followed the MTB's targeted therapy recommendations experienced a 67% objective response rate, with a median progression-free survival of 6.3 months and overall survival of 10.4 months, indicating the efficacy of this decision-making methodology in treating metastatic NSCLC.
Relevance and Effectiveness of Molecular Tumor Board Recommendations for Patients With Non-Small-Cell Lung Cancer With Rare or Complex Mutational Profiles.Koopman, B., van der Wekken, AJ., Ter Elst, A., et al.[2022]
In 2021, a study involving 1,029 patients assessed by a molecular tumor board (MTB) revealed a high recommendation discordance rate of 45.6%, indicating significant differences between MTB recommendations and those from next-generation sequencing vendors.
The MTB's interventions led to an impressive potential drug cost avoidance of over $3.2 million, highlighting the financial and clinical value of using MTBs to guide appropriate targeted therapies in cancer treatment.
Quantifying the Value of the Molecular Tumor Board: Discordance Recommendation Rate and Drug Cost Avoidance.Walters, MK., Ackerman, AT., Weese, JL., et al.[2022]
In a study of 251 cancer patients, molecular tumor boards (MTBs) provided treatment recommendations for nearly half of the cases, with the highest success rates seen in intrahepatic cholangiocarcinoma (66.7%) and gastric adenocarcinoma (62.5%).
Patients receiving MTB-recommended therapies had a significantly longer progression-free survival (PFS) of 6.30 months compared to 2.83 months for those on alternative treatments, highlighting the potential efficacy of high-tier evidence-based MTB therapies.
Critical evaluation of molecular tumour board outcomes following 2 years of clinical practice in a Comprehensive Cancer Centre.Scheiter, A., Hierl, F., Lüke, F., et al.[2023]

References

Relevance and Effectiveness of Molecular Tumor Board Recommendations for Patients With Non-Small-Cell Lung Cancer With Rare or Complex Mutational Profiles. [2022]
Quantifying the Value of the Molecular Tumor Board: Discordance Recommendation Rate and Drug Cost Avoidance. [2022]
Critical evaluation of molecular tumour board outcomes following 2 years of clinical practice in a Comprehensive Cancer Centre. [2023]
Impact of Molecular Tumor Board on the Clinical Management of Patients With Cancer. [2022]
Multicenter Comparison of Molecular Tumor Boards in The Netherlands: Definition, Composition, Methods, and Targeted Therapy Recommendations. [2021]
Molecular Tumor Board-Assisted Care in an Advanced Cancer Population: Results of a Phase II Clinical Trial. [2023]
Precision medicine-based therapies in advanced colorectal cancer: The University of California San Diego Molecular Tumor Board experience. [2022]