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Tempus NSCLC Surveillance Study: A ctDNA Biomarker Profiling Study of Patients With NSCLC Using NGS Assays

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05236114
Recruitment Status : Recruiting
First Posted : February 11, 2022
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Tempus Labs

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

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Other: Observation

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Study Type : Observational
Estimated Enrollment : 338 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tempus NSCLC Surveillance Study: A Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC) Using Comprehensive Next-Generation Sequencing (NGS) Assays
Actual Study Start Date : June 22, 2022
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort 1
Cohort 1 will include patients with early-stage and locally advanced disease (stages I-IIIa) who are candidates for definitive surgical resection.
Other: Observation
No intervention

Cohort 2
Cohort 2 will include patients who have advanced or metastatic disease (stages IIIB-IV) and are not surgical candidates.
Other: Observation
No intervention




Primary Outcome Measures :
  1. Recurrence-Free Survival [ Time Frame: 2 years ]
    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. Progression-Free Survival [ Time Frame: 2 years ]
    Progression-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic progression or death


Secondary Outcome Measures :
  1. Sensitivity [ Time Frame: 2 years ]
    Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected.

  2. Specificity [ Time Frame: 2 years ]
    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.

  3. Positive Predictive Value [ Time Frame: 2 years ]
    Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur.


Other Outcome Measures:
  1. Overall Survival [ Time Frame: 2 years or until the patient is reported deceased, whichever came first ]
    The duration of time between enrollment and death for any reason

  2. Lead Time [ Time Frame: 2 years ]
    Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.


Biospecimen Retention:   Samples With DNA
Blood and tissue samples will be collected


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This protocol targets patients with Non-Small Cell Lung Cancer (NSCLC)
Criteria

Inclusion Criteria:

  1. A known or suspected lung cancer
  2. Undergoing or has undergone a transbronchial needle aspiration (TBNA) or lung biopsy of a lung nodule or lung mass or thoracic lymph node biopsy for the purpose of diagnosis or staging of lung cancer
  3. Patients who don't undergo a biopsy and instead move directly to a surgical resection as dictated by the treating physician will be allowed to enter the study at the relevant time point
  4. 18 years old or older
  5. Willing and able to provide informed consent
  6. Willing to have additional blood samples collected during routine surveillance visits
  7. Lung cancer diagnosis post-initial biopsy or resection

Exclusion Criteria:

  1. Suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e., those without a known or suspected lung primary diagnosis)
  2. Not willing to have additional blood samples collected

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05236114


Contacts
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Contact: NSCLC Surveillance Study (833) 514-4187 gemini-nsclc@tempus.com

Locations
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United States, California
MemorialCare Recruiting
Fountain Valley, California, United States, 92708
Contact: Tuyet Collucci    562-706-1195    TCollucci@memorialcare.org   
Principal Investigator: Amol Rao, MD         
United States, Ohio
Aultman Hospital Recruiting
Canton, Ohio, United States, 44710
Contact: Carla Larch    330-363-1250    carla.larch@aultman.com   
Principal Investigator: Sareena Singh, MD         
TriHealth Cancer Institute Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Wayne Thompson    513-865-5020    Wayne_Thompson@trihealth.com   
Principal Investigator: Leanne Budde, MD         
United States, Wisconsin
ThedaCare Regional Cancer Center Recruiting
Appleton, Wisconsin, United States, 54911
Contact: Rachel Luedtke    920-364-3616    Rachel.Luedtke@thedacare.org   
Principal Investigator: Matthias Weiss, MD         
Sponsors and Collaborators
Tempus Labs
Investigators
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Principal Investigator: Kristiyana Kaneva, MD, MS Tempus Labs, Inc.
Publications:
Lam V, Tran H, Vasquez M, et al. MA23.02 Circulating Tumor DNA Analysis with a Novel Variant Classifier for Recurrence Detection in Resected, Early-Stage Lung Cancer. Journal of Thoracic Oncology 2018;13(10):S438.
Guardant Health, Inc. ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation. clinicaltrials.gov; 2021. Available from: https://clinicaltrials.gov/ct2/show/NCT05059444.

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Responsible Party: Tempus Labs
ClinicalTrials.gov Identifier: NCT05236114    
Other Study ID Numbers: TP-CA-002
First Posted: February 11, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tempus Labs:
Cancer
Oncology
Observational
Genomic Profiling
Precision medicine
Non-Small Cell Lung Cancer
NSCLC
NGS
Biomarkers
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms