GEMINI-NSCLC: NSCLC Biomarker Study

NCT05236114 | Recruiting

• 1 other identifier: TP-CA-002
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 58

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Cancer; Oncology; Observational; Genomic Profiling; Precision medicine; Non-Small Cell Lung Cancer; NSCLC; NGS; Biomarkers

Outcome Measures

Primary Outcomes (2)

• Real-World Disease Free Survival (rwDFS)

  5 years

• Real-World Overall Survival (rwOS)

  3 years

Secondary Outcomes (10)

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

  5 years

• 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

  5 years

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

  5 years

• pCR rate stratified by ctDNA status

  5 years

• Real-World Overall Survival (rwOS) stratified by ctDNA status at benchmark

  5 years

Other Outcomes (11)

• Prevalence of genomic variants at landmark timepoints

  5 years

• Compare ctDNA levels detected before and after biopsy

  5 years

• Prevalence of genomic variants at landmark timepoints

  18 months

Study Arms (2)

Cohort 1

Cohort 1 will include patients with early-stage (Stages I-IIIB) who are candidates for treatment with curative intent, surgery with or without perioperative (neoadjuvant or adjuvant) therapy.

Other: Observation

Cohort 2

Cohort 2 will include patients with stage IV disease receiving first line immunotherapy (as monotherapy or in combination with chemotherapy).

Other: Observation

Interventions

Observation OTHER

No intervention

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• 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.
• 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
• 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.

Sponsors & Collaborators

• Tempus AI: lead
• AstraZeneca: collaborator

Study Sites (58)

Alabama Oncology

Birmingham, Alabama, 35223, United States

RECRUITING

Mercy Clinic Oncology - Fort Smith

Fort Smith, Arkansas, 72903, United States

RECRUITING

MemorialCare

Fountain Valley, California, 92708, United States

RECRUITING

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

ACTIVE NOT RECRUITING

UCLA

Los Angeles, California, 90095, United States

RECRUITING

Eastern CT and Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

RECRUITING

Clermont Oncology Center

Clermont, Florida, 34711, United States

RECRUITING

Woodlands Medical Specialists

Pensacola, Florida, 32503, United States

WITHDRAWN

Morehouse School of Medicine (MSM)

Atlanta, Georgia, 30310, United States

RECRUITING

Piedmont Healthcare

Atlanta, Georgia, 30318, United States

RECRUITING

Hawaii Cancer Care

Honolulu, Hawaii, 96813, United States

RECRUITING

Southern Illinois Hospital Services

Carterville, Illinois, 62918, United States

RECRUITING

Cancer Care Specialists of Illinois

Decatur, Illinois, 62526, United States

RECRUITING

Northwestern University

Evanston, Illinois, 60208, United States

RECRUITING

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

RECRUITING

OSF Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

RECRUITING

Community Health Network

Indianapolis, Indiana, 46250, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

The Center for Cancer and Blood Disorder

Bethesda, Maryland, 20817, United States

RECRUITING

Frederick Health Regional System

Frederick, Maryland, 21702, United States

RECRUITING

Mercy Clinic Oncology and Hematology - Joplin

Joplin, Missouri, 64804, United States

RECRUITING

Lake Regional Health System

Osage Beach, Missouri, 65065, United States

RECRUITING

Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center

Springfield, Missouri, 65804, United States

RECRUITING

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

RECRUITING

Mercy Clinic Oncology and Hematology - Sindelar Cancer Center

St Louis, Missouri, 63128, United States

RECRUITING

Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center

St Louis, Missouri, 63141, United States

RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

OptumCare Cancer Care

Las Vegas, Nevada, 89102, United States

RECRUITING

Hope Cancer Care of Nevada

Las Vegas, Nevada, 89103, United States

RECRUITING

Cancer Care Specialists Reno

Reno, Nevada, 89511, United States

RECRUITING

New Jersey Cancer Center

Belleville, New Jersey, 07109, United States

RECRUITING

New York Oncology Hematology

Albany, New York, 12206, United States

RECRUITING

Hematology Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

RECRUITING

Cayuga Medical Center

Ithaca, New York, 14850, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

White Plains Hospital

White Plains, New York, 10601, United States

RECRUITING

UNC

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Southeastern Medical Oncology Center (SMOC)

Goldsboro, North Carolina, 27534, United States

RECRUITING

Aultman Hospital

Canton, Ohio, 44710, United States

RECRUITING

TriHealth Cancer Institute

Cincinnati, Ohio, 45220, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

OhioHealth Reseach Institute

Columbus, Ohio, 43214, United States

RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, 43537, United States

RECRUITING

Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States

RECRUITING

Mercy Clinic Oncology and Hematology - Coletta

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74146, United States

RECRUITING

Oregon Oncology Specialists

Salem, Oregon, 97301, United States

RECRUITING

Cancer Care Associates of York

York, Pennsylvania, 17403, United States

RECRUITING

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

PeaceHealth St. Joseph Medical Center-Bellingham

Bellingham, Washington, 98225, United States

RECRUITING

Cancer Care Northwest

Spokane Valley, Washington, 99216, United States

RECRUITING

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

RECRUITING

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue samples will be collected

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Virginia Rhodes, MD

  Tempus AI, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GEMINI NSCLC

CONTACT

(833) 514-4187; gemini-nsclc@tempus.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 11, 2022
• Study Start: June 22, 2022
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (58)