Personalized Treatment Planning for Non-Small Cell Lung Cancer

(PRiMAL Trial)

Overseen By Timothy Mullett, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Timothy Mullett

Disqualifiers: Infection, Heart failure, Angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to planning treatment for individuals with Non-Small Cell Lung Cancer (NSCLC). The researchers aim to determine if using a Molecular Tumor Board Assisted Care—a team of cancer experts—to develop personalized treatment plans is more effective than standard care. The trial seeks participants recently diagnosed with stage IIb-IV NSCLC who have not yet received any systemic cancer treatments, although previous surgery or radiation is acceptable. This trial may suit those newly diagnosed with this type of lung cancer who have not started chemotherapy or similar treatments. As an unphased trial, it offers a unique opportunity to contribute to innovative cancer care strategies.

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 prior data suggests that Molecular Tumor Board Assisted Care is safe for patients with Non-Small Cell Lung Cancer?

Research shows that care guided by a Molecular Tumor Board (MTB) is generally well-tolerated by patients. Studies have found that patients with non-small cell lung cancer who received MTB-guided care did not experience more side effects than those who received regular care. This suggests the treatment is safe. Additionally, MTB-guided care has been linked to better outcomes, such as longer periods without cancer progression and longer overall survival, without additional safety concerns. This evidence supports the treatment's safety as promising for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Molecular Tumor Board Assisted Care for non-small cell lung cancer because it offers a personalized approach to treatment. Unlike standard options that often involve a one-size-fits-all strategy, this method leverages a team of experts to tailor treatment plans based on the unique molecular makeup of an individual's tumor. This precision approach has the potential to improve outcomes by targeting the specific characteristics of each patient's cancer, potentially leading to more effective and less toxic treatments.

What evidence suggests that Molecular Tumor Board Assisted Care is effective for Non-Small Cell Lung Cancer?

Research has shown that using a Molecular Tumor Board (MTB) can extend the lives of people with non-small cell lung cancer. In this trial, some participants will receive care guided by an MTB, while others will receive usual care. Studies have found that patients whose cases were reviewed by an MTB had better overall survival compared to those without this type of review. Another study found that treatment guided by an MTB slowed the progression of cancer. These findings suggest that care involving an MTB can be a promising way to improve outcomes for people with this type of lung cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Timothy Mullett, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Molecular Tumor Board Assisted Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Molecular tumor board intervention Experimental Treatment 1 Intervention

Group II: Usual care recipients Active Control 1 Intervention

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

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 a study of 93 patients with advanced cancer, those receiving therapy recommended by multidisciplinary molecular tumor boards (MTBs) showed a significant improvement in progression-free survival (PFS), with a probability of achieving a PFS ratio of ≥ 1.3 at 59%.

The median PFS for patients treated with MTB-directed therapy was 449 days, and the median overall survival was 768 days, suggesting that MTB-directed therapy can be an effective strategy for improving outcomes in advanced cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Tumor Board-Assisted Care in an Advanced Cancer Population: Results of a Phase II Clinical Trial. Miller, RW., Hutchcraft, ML., Weiss, HL., et al.[2023]

Molecular tumor boards (MTBs) in The Netherlands are consistently structured and show a high level of agreement (86%) in treatment recommendations for patients with rare or complex mutational cancer profiles, indicating their effectiveness in guiding targeted therapies.

The study suggests a 'Dutch MTB model' that promotes collaboration and data sharing among institutions, which could enhance the quality and consistency of treatment recommendations across different cancer centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Comparison of Molecular Tumor Boards in The Netherlands: Definition, Composition, Methods, and Targeted Therapy Recommendations. Koopman, B., Groen, HJM., Ligtenberg, MJL., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 51 patients with advanced colorectal cancer, a personalized treatment approach using a Molecular Tumor Board (MTB) led to 67% of patients receiving therapies matched to their tumor characteristics, which is a significant improvement over standard treatments.

Patients who received matched therapies showed a 59% reduction in the risk of disease progression compared to those on unmatched therapies, indicating that personalized medicine can enhance treatment outcomes in advanced colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision medicine-based therapies in advanced colorectal cancer: The University of California San Diego Molecular Tumor Board experience. Louie, BH., Kato, S., Kim, KH., et al.[2022]

In a study involving 328 cancer patients discussed in multidisciplinary tumor boards (MTBs), 60.7% of cases resulted in a recommended change in clinical management, highlighting the significant impact of MTBs on treatment decisions.

Compliance with MTB recommendations for changing clinical management was 58.5%, indicating that while MTBs provide valuable insights into targeted therapies, there is still room for improvement in implementing these recommendations in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Molecular Tumor Board on the Clinical Management of Patients With Cancer. Behel, V., Noronha, V., Choughule, A., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/PO.21.00524

Results of a Phase II Clinical Trial | JCO Precision Oncology The purpose of this study was to determine if MTB-directed therapy improves progression-free survival (PFS) over immediately prior therapy in patients with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8492377/

Molecular Tumor Board Review and Improved Overall ... Patients with non–small-cell lung cancer reviewed by an MTB had improved OS when compared with propensity-matched controls without an MTB review ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05254795

Study Details | NCT05254795 | Precision Medicine ... This trial will compare Molecular Tumor Board (MTB) assisted care to usual care for patients who have newly diagnosed histologically or cytologically confirmed ...

4. jto.org jto.org/article/S1556-0864(25)00831-7/fulltext

Molecular Tumor Boards: A Consensus Statement From ... Molecular tumor board Review and improved overall survival in non-small-cell lung cancer. JCO Precis Oncol. 2021; 5, PO.21.00210. Google ...

5. nature.com nature.com/articles/s41698-025-00865-1

Systematic review and meta-analysis of molecular tumor ... Molecular tumor board review and improved overall survival in non-small-cell lung cancer. JCO Precis. Oncol. 5, PO.21.00210 (2021). Kato, S ...

6. ukhealthcare.uky.edu ukhealthcare.uky.edu/markey-cancer-center/research/molecular-tumor-board/primal

Primal Study - UK HealthCare This trial will compare Molecular Tumor Board (MTB) assisted care to usual care for patients who have newly diagnosed histologically or cytologically confirmed ...