Tempus NSCLC Surveillance Study: A ctDNA Biomarker Profiling Study of Patients With NSCLC Using NGS Assays
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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
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Condition or disease | Intervention/treatment |
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Non-Small Cell Lung Cancer | Other: Observation |
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 |

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.
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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.
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Other: Observation
No intervention |
- 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
- 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
- Sensitivity [ Time Frame: 2 years ]Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected.
- 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.
- Positive Predictive Value [ Time Frame: 2 years ]Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur.
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
Inclusion Criteria:
- A known or suspected lung cancer
- 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
- 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
- 18 years old or older
- Willing and able to provide informed consent
- Willing to have additional blood samples collected during routine surveillance visits
- Lung cancer diagnosis post-initial biopsy or resection
Exclusion Criteria:
- Suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e., those without a known or suspected lung primary diagnosis)
- Not willing to have additional blood samples collected

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
Contact: NSCLC Surveillance Study | (833) 514-4187 | gemini-nsclc@tempus.com |
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 |
Principal Investigator: | Kristiyana Kaneva, MD, MS | Tempus Labs, Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cancer Oncology Observational Genomic Profiling Precision medicine |
Non-Small Cell Lung Cancer NSCLC NGS Biomarkers |
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 |