Collecting health information from patients with non-small cell lung cancer
Official title: TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC)
Run by Tempus AI · NCT05236114 · Data updated 2026-11-12
This study is trying to collect health information from people with non-small cell lung cancer to see how their cancer changes over time and how it responds to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1200 (estimated) |
| Sponsor | Tempus AI Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 58 sites (Birmingham, Alabama and 57 other locations) |
| Status | Recruiting |
| Started | June 22, 2022 |
| Main results expected | June 2029 |
| Study ends | June 2029 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT05236114 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with known or suspected resectable NSCLC who are undergoing or planning to undergo surgical resection.
✕Probably not a fit
Patients with unresectable tumors or those who do not have a confirmed diagnosis of NSCLC may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The GEMINI NSCLC study is an observational study that aims to gather clinical and molecular health data from patients diagnosed with non-small cell lung cancer (NSCLC). Participants will undergo longitudinal blood collection alongside their standard care therapy to monitor the molecular evolution of their cancer. The study seeks to evaluate the dynamics of circulating tumor DNA (ctDNA) to predict the risk of cancer recurrence and therapeutic outcomes. This approach will help in understanding how NSCLC responds to treatment over time.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict cancer recurrence and improve treatment strategies for patients with NSCLC.
How similar studies have gone: Other studies utilizing ctDNA dynamics in cancer monitoring have shown promising results, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 Exclusion Criteria (both Cohorts): * Patients without a known or suspected NSCLC diagnosis, or other disease processes such as sarcoidosis, lymphoma, or metastatic cancer from other sites. * Not willing to have additional blood samples collected * 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: * 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.
Where it's running
-
Alabama Oncology
Birmingham, Alabama, United States Recruiting -
Mercy Clinic Oncology - Fort Smith
Fort Smith, Arkansas, United States Recruiting -
MemorialCare
Fountain Valley, California, United States Recruiting -
UCLA
Los Angeles, California, United States Recruiting -
Eastern CT and Hematology and Oncology Associates
Norwich, Connecticut, United States Recruiting -
Clermont Oncology Center
Clermont, Florida, United States Recruiting
Show 44 more locations
-
Morehouse School of Medicine (MSM)
Atlanta, Georgia, United States Recruiting -
Piedmont Healthcare
Atlanta, Georgia, United States Recruiting -
Hawaii Cancer Care
Honolulu, Hawaii, United States Recruiting -
Southern Illinois Hospital Services
Carterville, Illinois, United States Recruiting -
Cancer Care Specialists of Illinois
Decatur, Illinois, United States Recruiting -
Northwestern University
Evanston, Illinois, United States Recruiting -
Hope and Healing Cancer Services
Hinsdale, Illinois, United States Recruiting -
OSF Saint Anthony Medical Center
Rockford, Illinois, United States Recruiting -
Community Health Network
Indianapolis, Indiana, United States Recruiting -
University of Iowa
Iowa City, Iowa, United States Recruiting -
University of Maryland
Baltimore, Maryland, United States Recruiting -
Johns Hopkins University
Baltimore, Maryland, United States Recruiting -
The Center for Cancer and Blood Disorder
Bethesda, Maryland, United States Recruiting -
Frederick Health Regional System
Frederick, Maryland, United States Recruiting -
Mercy Clinic Oncology and Hematology - Joplin
Joplin, Missouri, United States Recruiting -
Lake Regional Health System
Osage Beach, Missouri, United States Recruiting -
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
Springfield, Missouri, United States Recruiting -
Oncology Hematology Associates
Springfield, Missouri, United States Recruiting -
Mercy Clinic Oncology and Hematology - Sindelar Cancer Center
St Louis, Missouri, United States Recruiting -
Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
St Louis, Missouri, United States Recruiting -
Nebraska Cancer Specialists
Omaha, Nebraska, United States Recruiting -
OptumCare Cancer Care
Las Vegas, Nevada, United States Recruiting -
Hope Cancer Care of Nevada
Las Vegas, Nevada, United States Recruiting -
Cancer Care Specialists Reno
Reno, Nevada, United States Recruiting -
New Jersey Cancer Center
Belleville, New Jersey, United States Recruiting -
New York Oncology Hematology
Albany, New York, United States Recruiting -
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States Recruiting -
Cayuga Medical Center
Ithaca, New York, United States Recruiting -
Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting -
White Plains Hospital
White Plains, New York, United States Recruiting -
UNC
Chapel Hill, North Carolina, United States Recruiting -
Duke University
Durham, North Carolina, United States Recruiting -
Southeastern Medical Oncology Center (SMOC)
Goldsboro, North Carolina, United States Recruiting -
Aultman Hospital
Canton, Ohio, United States Recruiting -
TriHealth Cancer Institute
Cincinnati, Ohio, United States Recruiting -
Ohio State University
Columbus, Ohio, United States Recruiting -
OhioHealth Reseach Institute
Columbus, Ohio, United States Recruiting -
Taylor Cancer Research Center
Maumee, Ohio, United States Recruiting -
Hightower Clinical
Oklahoma City, Oklahoma, United States Recruiting -
Mercy Clinic Oncology and Hematology - Coletta
Oklahoma City, Oklahoma, United States Recruiting -
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States Recruiting -
Oregon Oncology Specialists
Salem, Oregon, United States Recruiting -
Cancer Care Associates of York
York, Pennsylvania, United States Recruiting -
The Medical University of South Carolina
Charleston, South Carolina, United States Recruiting
+8 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Virginia Rhodes, MD — Tempus AI, Inc.
- Study coordinator: Gemini Nsclc
- Email: gemini-nsclc@tempus.com
- Phone: (833) 514-4187
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Patient-specific MRD liquid biopsy for resected NSCLC
This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.
-
Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases
This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.
-
Dato-DXd in solid tumors (Urothelial Cancer and KRAS-mutant NSCLC) in two sub-studies
This study tests Datopotamab Deruxtecan (Dato-DXd) alone or with other cancer drugs in people with urothelial cancer or KRAS-mutant non-small cell lung cancer.
-
SI-B036 safety test in advanced and metastatic solid tumors
This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.
-
Postoperative EGFR-TKI Therapy for EGFR-mutant NSCLC Following Surgery
This registry tests whether giving an EGFR-TKI after surgery helps adults with EGFR-mutant, high-risk early-stage NSCLC.
-
HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC
This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.