Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
1200 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-06-22
Study Completion Date
2029-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Non-Small Cell Lung Cancer
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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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.
Observation
Intervention Type
OTHER
No intervention
Cohort 2
Cohort 2 will include patients with stage IV disease receiving first line immunotherapy (as monotherapy or in combination with chemotherapy).
Observation
Intervention Type
OTHER
No intervention
Interventions
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Observation
No intervention
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion 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
* 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.
* 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
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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AstraZeneca
INDUSTRY
Sponsor Role
collaborator
Tempus AI
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Virginia Rhodes, MD
Role: PRINCIPAL_INVESTIGATOR
Tempus AI, Inc.
Locations
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Alabama Oncology
Birmingham, Alabama, United States
Site Status
RECRUITING
Mercy Clinic Oncology - Fort Smith
Fort Smith, Arkansas, United States
Site Status
RECRUITING
MemorialCare
Fountain Valley, California, United States
Site Status
RECRUITING
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Site Status
ACTIVE_NOT_RECRUITING
Eastern CT and Hematology and Oncology Associates
Norwich, Connecticut, United States
Site Status
RECRUITING
Clermont Oncology Center
Clermont, Florida, United States
Site Status
RECRUITING
Woodlands Medical Specialists
Pensacola, Florida, United States
Site Status
WITHDRAWN
Morehouse School of Medicine (MSM)
Atlanta, Georgia, United States
Site Status
RECRUITING
Piedmont Healthcare
Atlanta, Georgia, United States
Site Status
RECRUITING
Hawaii Cancer Care
Honolulu, Hawaii, United States
Site Status
RECRUITING
Southern Illinois Hospital Services
Carterville, Illinois, United States
Site Status
RECRUITING
Cancer Care Specialists of Illinois
Decatur, Illinois, United States
Site Status
RECRUITING
Northwestern University
Evanston, Illinois, United States
Site Status
RECRUITING
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Site Status
RECRUITING
OSF Saint Anthony Medical Center
Rockford, Illinois, United States
Site Status
RECRUITING
Community Health Network
Indianapolis, Indiana, United States
Site Status
RECRUITING
University of Iowa
Iowa City, Iowa, United States
Site Status
RECRUITING
University of Maryland
Baltimore, Maryland, United States
Site Status
RECRUITING
Johns Hopkins University
Baltimore, Maryland, United States
Site Status
RECRUITING
The Center for Cancer and Blood Disorder
Bethesda, Maryland, United States
Site Status
RECRUITING
Frederick Health Regional System
Frederick, Maryland, United States
Site Status
RECRUITING
Mercy Clinic Oncology and Hematology - Joplin
Joplin, Missouri, United States
Site Status
RECRUITING
Lake Regional Health System
Osage Beach, Missouri, United States
Site Status
RECRUITING
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
Springfield, Missouri, United States
Site Status
RECRUITING
Oncology Hematology Associates
Springfield, Missouri, United States
Site Status
RECRUITING
Mercy Clinic Oncology and Hematology - Sindelar Cancer Center
St Louis, Missouri, United States
Site Status
RECRUITING
Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
St Louis, Missouri, United States
Site Status
RECRUITING
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Site Status
RECRUITING
OptumCare Cancer Care
Las Vegas, Nevada, United States
Site Status
RECRUITING
Hope Cancer Care of Nevada
Las Vegas, Nevada, United States
Site Status
RECRUITING
Cancer Care Specialists Reno
Reno, Nevada, United States
Site Status
RECRUITING
New Jersey Cancer Center
Belleville, New Jersey, United States
Site Status
RECRUITING
New York Oncology Hematology
Albany, New York, United States
Site Status
RECRUITING
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States
Site Status
RECRUITING
Cayuga Medical Center
Ithaca, New York, United States
Site Status
RECRUITING
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Site Status
RECRUITING
White Plains Hospital
White Plains, New York, United States
Site Status
RECRUITING
UNC
Chapel Hill, North Carolina, United States
Site Status
RECRUITING
Duke University
Durham, North Carolina, United States
Site Status
RECRUITING
Southeastern Medical Oncology Center (SMOC)
Goldsboro, North Carolina, United States
Site Status
RECRUITING
Aultman Hospital
Canton, Ohio, United States
Site Status
RECRUITING
TriHealth Cancer Institute
Cincinnati, Ohio, United States
Site Status
RECRUITING
Ohio State University
Columbus, Ohio, United States
Site Status
RECRUITING
OhioHealth Reseach Institute
Columbus, Ohio, United States
Site Status
RECRUITING
Taylor Cancer Research Center
Maumee, Ohio, United States
Site Status
RECRUITING
Hightower Clinical
Oklahoma City, Oklahoma, United States
Site Status
RECRUITING
Mercy Clinic Oncology and Hematology - Coletta
Oklahoma City, Oklahoma, United States
Site Status
RECRUITING
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States
Site Status
RECRUITING
Oregon Oncology Specialists
Salem, Oregon, United States
Site Status
RECRUITING
Cancer Care Associates of York
York, Pennsylvania, United States
Site Status
RECRUITING
The Medical University of South Carolina
Charleston, South Carolina, United States
Site Status
RECRUITING
Baptist Cancer Center
Memphis, Tennessee, United States
Site Status
RECRUITING
University of Virginia
Charlottesville, Virginia, United States
Site Status
RECRUITING
PeaceHealth St. Joseph Medical Center-Bellingham
Bellingham, Washington, United States
Site Status
RECRUITING
Cancer Care Northwest
Spokane Valley, Washington, United States
Site Status
RECRUITING
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
Site Status
RECRUITING
Gundersen Health System
La Crosse, Wisconsin, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
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Lynch TJ, Bell DW, Sordella R, Gurubhagavatula S, Okimoto RA, Brannigan BW, Harris PL, Haserlat SM, Supko JG, Haluska FG, Louis DN, Christiani DC, Settleman J, Haber DA. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med. 2004 May 20;350(21):2129-39. doi: 10.1056/NEJMoa040938. Epub 2004 Apr 29.
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Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Ogura T, Ando M, Miyazawa H, Tanaka T, Saijo Y, Hagiwara K, Morita S, Nukiwa T; North-East Japan Study Group. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010 Jun 24;362(25):2380-8. doi: 10.1056/NEJMoa0909530.
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Ramalingam SS, Vansteenkiste J, Planchard D, Cho BC, Gray JE, Ohe Y, Zhou C, Reungwetwattana T, Cheng Y, Chewaskulyong B, Shah R, Cobo M, Lee KH, Cheema P, Tiseo M, John T, Lin MC, Imamura F, Kurata T, Todd A, Hodge R, Saggese M, Rukazenkov Y, Soria JC; FLAURA Investigators. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020 Jan 2;382(1):41-50. doi: 10.1056/NEJMoa1913662. Epub 2019 Nov 21.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TP-CA-002
Identifier Type: -
Identifier Source: org_study_id
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