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

Timothy Mullett

Status: Enrolling

Conditions: Non-Small Cell Lung Cancer

Treatments: Other: Molecular tumor board assisted care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05254795

MCC-21-LUN-126-PMC

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically suspected or histologically confirmed stage IIb-IV NSCLC who are planning to undergo treatment
• No prior systemic therapies for NSCLC, with the exception of adjuvant therapy for early stage NSCLC. Prior surgery and/or radiation is allowed.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
• Pregnancy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Usual care recipients

No Intervention group

Molecular tumor board intervention

Experimental group

Treatment:

Other: Molecular tumor board assisted care