Clinical trial Recruiting at 56 sites Observational Ages 18 and up

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.

More Non-Small Cell Lung Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1200 (estimated)
SponsorTempus AI
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations58 sites (Birmingham, Alabama and 57 other locations)
StatusRecruiting
StartedJune 22, 2022
Main results expectedJune 2029
Study endsJune 2029
Registry record updatedFebruary 5, 2026
Trial IDNCT05236114 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.