Lung Cancer Trials Ask AI to find trials
RecruitingNot applicableNCT05236114
Official study title

GEMINI-NSCLC: NSCLC Biomarker Study

Study summary

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.

Ask AI to explain this study
Start here

Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedObservation

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 5, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Observational

Where is it offered?58 U.S. locations

Locations may change over time.

Who runs it?Tempus AI

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Tempus AI
Interventions being studied
Other: Observation
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Recurrent or relapsed→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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/
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Alabama OncologyBirmingham, Alabama
  • Mercy Clinic Oncology - Fort SmithFort Smith, Arkansas
  • MemorialCareFountain Valley, California
  • Cancer and Blood Specialty ClinicLos Alamitos, California
  • UCLALos Angeles, California
  • Eastern CT and Hematology and Oncology AssociatesNorwich, Connecticut
  • Clermont Oncology CenterClermont, Florida
  • Woodlands Medical SpecialistsPensacola, Florida
  • Morehouse School of Medicine (MSM)Atlanta, Georgia
  • Piedmont HealthcareAtlanta, Georgia
  • Hawaii Cancer CareHonolulu, Hawaii
  • Southern Illinois Hospital ServicesCarterville, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 5, 2026. Always confirm current availability with the study team.

View original record ↗