Health TrialsbyHealthPanel

GEMINI-NSCLC: NSCLC Biomarker Study

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTempus AI

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

This protocol targets patients with Non-Small Cell Lung Cancer (NSCLC)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observation

    Other intervention

    No intervention

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Cohort 11 intervention
Group B: Cohort 21 intervention

Trial outcomes

Primary outcomes

1

Real-World Disease Free Survival (rwDFS)

Time frame
5 years
2

Real-World Overall Survival (rwOS)

Time frame
3 years

Secondary outcomes

1

Sensitivity, Specificity, PPV and NPV of MRD assay to predict recurrence at benchmark vs physician assessment of recurrence via conventional imaging every 6 months

Time frame
5 years
2

Sensitivity, Specificity, PPV and NPV of MRD assay to predict recurrence across longitudinal collections vs physician assessment of recurrence via conventional imaging every 6 months

Time frame
5 years
3

Real-World Disease Free Survival (rwDFS) stratified by ctDNA status at benchmark

Time frame
5 years
4

pCR rate stratified by ctDNA status

Time frame
5 years

Other outcomes

1

Prevalence of genomic variants at landmark timepoints

Time frame
5 years
2

Compare ctDNA levels detected before and after biopsy

Time frame
5 years
3

Prevalence of genomic variants at landmark timepoints

Time frame
18 months
4

Identification of the emergence of genomic variants and tumor biologic subclones over time with early-stage and advanced stage lung cancer

Time frame
5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tempus AI

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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