Back to search results

GEMINI-NSCLC: Non-Small Cell Lung Cancer Biomarker Study

This is an observational study called GEMINI-NSCLC for people with non-small cell lung cancer (NSCLC). Researchers are collecting health information and blood samples over time to understand how lung cancer changes with standard treatments. They also want to see if changes in circulating tumor DNA (ctDNA) in your blood can predict if your cancer will return or how well treatments work. You can join if you are 18 or older, have known or suspected NSCLC that can be treated with surgery, and are receiving standard care. The study will look at how long people live (overall survival) and how long they live without their disease returning (disease-free survival) over several years.

Study design
This is an observational study, meaning there are no new interventions. It plans to enroll 1200 participants.
What's involved
You would provide longitudinal blood samples in addition to your standard of care therapy and disease surveillance.
Compensation
Not stated in the trial record.
Follow-up
The study will measure real-world disease-free survival at 5 years and real-world overall survival at 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05236114

GEMINI-NSCLC: NSCLC Biomarker Study

Recruiting
Not specifiedAges 18+Observational
Tempus AI
~1,200 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Observation

At a glance

Recruiting sites
56 of 58 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Real-World Disease Free Survival (rwDFS)
Measured over 5 years
+1 more outcome measured

Conditions

Non-Small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaERBB2 GeneGTPase KRas

Where it's being run

58 sites across 26 states
Missouri6
Illinois5
New York5
Ohio5
Maryland4
California3
Nevada3
North Carolina3

Study leadership

  • Virginia Rhodes, MD · PRINCIPAL_INVESTIGATOR · Tempus AI, Inc.

Who to contact

GEMINI NSCLC
[email protected]
(833) 514-4187
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Real-World Disease Free Survival (rwDFS)5 years
  • Real-World Overall Survival (rwOS)3 years