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
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 design
Treatments tested in this trial
- Observation
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tempus AI
Lead sponsor
AstraZeneca
Collaborator
Source ClinicalTrials.gov