NCT05236114Recruiting
GEMINI-NSCLC: NSCLC Biomarker Study
TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
GEMINI NSCLC Study is a 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 with the goals of identifying the molecular evolution of lung cancer with standard of care therapy, and determining the utility of ctDNA dynamics to predict risk of recurrence and therapeutic outcomes.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 12 Jan 2022
- Start date
- 22 Jun 2022
- Primary completion date
- Jun 2029
- Lead sponsor
- Tempus AI
- Diseases
- Lung cancer
- NCT number
- NCT05236114
What you commit to
- Study type: Observational
- Planned participants: 1200
- From 22 Jun 2022 to the primary completion date, Jun 2029
- 58 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a secondary malignancy must have been both diagnosed \> 2 years from the lung cancer of interest and have completed all therapy for that malignancy (including extended adjuvant therapy) \> 2 years prior to diagnosis of the lung cancer of interest with the exception of the following:
Other illness
- Patients without a known or suspected NSCLC diagnosis, or other disease processes such as sarcoidosis, lymphoma, or metastatic cancer from other sites.
Age
- Patients with superficial basal cell carcinoma of low-risk histology per NCCN Guidelines (Low-risk histologic subtypes include nodular, superficial, and other non-aggressive growth patterns such as keratotic, infundibulocystic, and fibroepithelioma of Pinkus) and low-risk for recurrence per NCCN Guidelines (location on trunk or extremities, size \< 2 cm, primary (not recurrent), with well-defined borders) can be included even if they are diagnosed \< 2 years from the lung cancer of interest.
- Patients with superficial squamous cell carcinoma of low-risk pathology per NCCN Guidelines (verrucous, keratoacanthomatous) and low-risk for recurrence per NCCN Guidelines (located on trunk or extremities; 2 cm in size; primary lesion (vs. recurrent); well to moderately differentiated; \< 2 mm thick and no invasion beyond subcutaneous fat; negative for perineural invasion; and negative for lymphatic or vascular involvement) can be included even if they are diagnosed \< 2 years from the lung cancer of interest.
Other
- Not willing to have additional blood samples collected
Criteria the registry did not label
- For Cohort 1 Inclusion, the participant has/is:
- A known or suspected NSCLC treated with curative intent -(surgery with or without perioperative (neoadjuvant or adjuvant) therapy).
- Suspected NSCLC - Patients with a high index of suspicion for the diagnosis of NSCLC that is resectable may sign informed consent prior to undergoing diagnostic procedure at the discretion of the physician. NCCN Guidelines allow for clinical stage IA cancers to proceed directly to definitive surgery. Per NCCN Guidelines, if a preoperative tissue diagnosis has not been obtained, then an intraoperative diagnosis will be obtained. If a diagnosis of NSCLC is not confirmed and/or the tumor is not resectable, then the patient will be a screen failure.
- Undergone or planning to undergo a surgical resection - (Patients with stages I-IIIB who are resectable - per NCCN guidelines of resectability)
- Both patients who lack molecular abnormalities and those with identified molecular abnormalities may enroll. Choice of perioperative therapy is to follow SOC therapeutic guidelines for the participant's molecular and PD-L1 profile.
- 18 years old or older
- Willing and able to provide informed consent
- Willing to have additional blood samples collected during routine surveillance visits
- Must submit tumor sample representative of current disease
- For Cohort 1 Exclusion, the participant has/is:
- Patients with superior sulcus tumors who are candidates for preoperative concurrent chemoradiation.
- Stage III locally advanced and unresectable patients who are candidates for chemoradiation followed by immunotherapy.
- It is expected that all patients on the cohort will be treated with a definitive surgical resection. Thus, clinical stage IIIB and IIIC patients who subsequently demonstrate pathologically confirmed N3 nodal disease or T4 N2 or 3 per any confirmatory procedure listed in NCCN guidelines for which definitive chemoradiotherapy rather than surgery is recommended per NCCN Guidelines are not eligible.
- Patients who receive primary radiation (in lieu of surgery if they are not surgical candidates).
- For Cohort 2 Inclusion, the participant has/is:
- Histologically documented Stage IV NSCLC (de novo metastatic or relapse setting) not amenable to curative surgery or radiation therapy. Palliative radiation (for instance for impending bony fracture or to control pain) is allowed at any time during the protocol at the physician's discretion.
- Intended to receive first line immunotherapy (as monotherapy or in combination with chemotherapy). Patients who have had previous exposure to immunotherapy in the neoadjuvant or adjuvant setting are allowed to enroll as long as 12 months have elapsed since the prior exposure.
- Patients in surveillance on Cohort 1 are eligible to roll over to Cohort 2 at the time of recurrence as long as they have had histologic confirmation of recurrence and have been off immunotherapy for 12 months or greater and meet all other inclusion/exclusion criteria.
- Tumors that lack activating EGFR mutations (e.g., exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK fusions. Also, per NCCN Guideline recommended testing, tumors must also lack ROS1, BRAF, NTRK 1/2/3, METex14 skipping mutations, and RET for which there is available front-line targeted therapy. Only those patients with KRAS G12C mutations and ERBB2 (HER2) mutations with no contraindications to immunotherapy (PD-L1 1) for which there are no approved front-line targeted therapies and for whom immunotherapy would be the preferred front-line therapy are eligible.
- Patients may be enrolled with local molecular testing and those results will be provided.
- Patients may be enrolled with local molecular testing and those results will be provided.
- 18 years and older
- Willing and able to provide informed consent
- Willing to have additional blood samples collected during routine surveillance visits
- Must submit tumor sample representative of current disease
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (58)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New York Oncology Hematology Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| ThedaCare Regional Cancer Center Coordinator of this site? Confirm its status | Appleton | United States | Recruiting |
| Morehouse School of Medicine (MSM) Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Piedmont Healthcare Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| University of Maryland Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| New Jersey Cancer Center Coordinator of this site? Confirm its status | Belleville | United States | Recruiting |
| PeaceHealth St. Joseph Medical Center-Bellingham Coordinator of this site? Confirm its status | Bellingham | United States | Recruiting |
| The Center for Cancer and Blood Disorder Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| Alabama Oncology Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Aultman Hospital Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Southern Illinois Hospital Services Coordinator of this site? Confirm its status | Carterville | United States | Recruiting |
| UNC Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| The Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| TriHealth Cancer Institute Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Clermont Oncology Center Coordinator of this site? Confirm its status | Clermont | United States | Recruiting |
| OhioHealth Reseach Institute Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Cancer Care Specialists of Illinois Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Hematology Oncology Associates of Central New York Coordinator of this site? Confirm its status | East Syracuse | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Evanston | United States | Recruiting |
| Mercy Clinic Oncology - Fort Smith Coordinator of this site? Confirm its status | Fort Smith | United States | Recruiting |
| MemorialCare Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| Frederick Health Regional System Coordinator of this site? Confirm its status | Frederick | United States | Recruiting |
| Southeastern Medical Oncology Center (SMOC) Coordinator of this site? Confirm its status | Goldsboro | United States | Recruiting |
| Hope and Healing Cancer Services Coordinator of this site? Confirm its status | Hinsdale | United States | Recruiting |
| Hawaii Cancer Care Coordinator of this site? Confirm its status | Honolulu | United States | Recruiting |
| Community Health Network Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| Cayuga Medical Center Coordinator of this site? Confirm its status | Ithaca | United States | Recruiting |
| Mercy Clinic Oncology and Hematology - Joplin Coordinator of this site? Confirm its status | Joplin | United States | Recruiting |
| Gundersen Health System Coordinator of this site? Confirm its status | La Crosse | United States | Recruiting |
| OptumCare Cancer Care Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Hope Cancer Care of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Cancer and Blood Specialty Clinic Coordinator of this site? Confirm its status | Los Alamitos | United States | Active, not recruiting |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Taylor Cancer Research Center Coordinator of this site? Confirm its status | Maumee | United States | Recruiting |
| Baptist Cancer Center Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Eastern CT and Hematology and Oncology Associates Coordinator of this site? Confirm its status | Norwich | United States | Recruiting |
| Hightower Clinical Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Mercy Clinic Oncology and Hematology - Coletta Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Nebraska Cancer Specialists Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Lake Regional Health System Coordinator of this site? Confirm its status | Osage Beach | United States | Recruiting |
| Woodlands Medical Specialists Coordinator of this site? Confirm its status | Pensacola | United States | Withdrawn |
| Cancer Care Specialists Reno Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| OSF Saint Anthony Medical Center Coordinator of this site? Confirm its status | Rockford | United States | Recruiting |
| Oregon Oncology Specialists Coordinator of this site? Confirm its status | Salem | United States | Recruiting |
| Cancer Care Northwest Coordinator of this site? Confirm its status | Spokane Valley | United States | Recruiting |
| Oncology Hematology Associates Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Mercy Clinic Oncology and Hematology Sindelar Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Oklahoma Cancer Specialists and Research Institute Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
| White Plains Hospital Coordinator of this site? Confirm its status | White Plains | United States | Recruiting |
| Cancer Care Associates of York Coordinator of this site? Confirm its status | York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.