GEMINI-NSCLC: NSCLC Biomarker Study

Study Overview
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Brief Summary
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Non-interventional study that will be collecting clinical and molecular health information from patients with NSCLC who will receive longitudinal blood collection in addition to their standard of care therapy and disease surveillance.

Official Title
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TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC)

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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For Cohort 1 Inclusion, the participant has/is: A known or suspected NSCLC treated with curative intent Undergone or planning to undergo a surgical resection 18 years old or older Willing and able to provide informed consent Willing to have additional blood samples collected during routine surveillance visits For Cohort 2 Inclusion, the participant has/is: Histologically or cytologically documented Stage IV NSCLC (de novo metastatic or relapse setting) not amenable to curative surgery or radiation therapy. Intended to receive first line immunotherapy (as monotherapy or in combination with chemotherapy) Tumors that lack activating EGFR mutations and ALK fusions 18 years and older Willing and able to provide informed consent Willing to have additional blood samples collected during routine surveillance visits Exclusion Criteria (both Cohorts): Suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e., those without a known or suspected NSCLC primary diagnosis) Not willing to have additional blood samples collected Patients with a secondary malignancy <2 years prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Cohort 1 will include patients with early-stage and locally advanced disease (stages I-IIIB) who are candidates for definitive surgical resection. | Other: Observation<br>* No intervention<br>|
| Cohort 2<br>Cohort 2 will include patients with stage IV disease receiving first line IO (mono/combo) therapy. | Other: Observation<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-Free Survival | Recurrence-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic recurrence or death | 2 years | 
| Progression-Free Survival | Progression-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic progression or death | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected. | 2 years | 
| Specificity | Specificity defined as the proportion of participants who do not develop recurrence who do not have ctDNA detected at or before the time of clinical detection of recurrence. | 2 years | 
| Positive Predictive Value | Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Oncology, Observational, Genomic Profiling, Precision medicine, Non-Small Cell Lung Cancer, NSCLC, NGS, Biomarkers