GEMINI-NSCLC: NSCLC Biomarker Study

Non-Small Cell Lung Cancer Clinical Trial

Official title:

TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05236114
• Other study ID #: TP-CA-002
• Status: Recruiting
• Start date: June 22, 2022
• Est. completion date: February 2027

Study information

• Verified date: May 2024
• Source: Tempus AI
• Contact: GEMINI NSCLC
• Phone: (833) 514-4187
• Email: gemini-nsclc[@]tempus.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 813
• Est. completion date: February 2027
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For Cohort 1 Inclusion, the participant has/is:

• A known or suspected NSCLC treated with curative intent
• Undergone or planning to undergo a surgical resection
• 18 years old or older
• Willing and able to provide informed consent
• Willing to have additional blood samples collected during routine surveillance visits

For Cohort 2 Inclusion, the participant has/is:

• Histologically or cytologically documented Stage IV NSCLC (de novo metastatic or relapse setting) not amenable to curative surgery or radiation therapy.
• Intended to receive first line immunotherapy (as monotherapy or in combination with chemotherapy)
• Tumors that lack activating EGFR mutations and ALK fusions
• 18 years and older
• Willing and able to provide informed consent
• Willing to have additional blood samples collected during routine surveillance visits

Exclusion Criteria (both Cohorts):

• Suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e., those without a known or suspected NSCLC primary diagnosis)
• Not willing to have additional blood samples collected
• Patients with a secondary malignancy <2 years prior to enrollment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Other:
• Observation
No intervention

Locations

Country	Name	City	State
United States	ThedaCare Regional Cancer Center	Appleton	Wisconsin
United States	Morehouse School of Medicine (MSM)	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	PeaceHealth St. Joseph Medical Center-Bellingham	Bellingham	Washington
United States	The Center for Cancer and Blood Disorder	Bethesda	Maryland
United States	Aultman Hospital	Canton	Ohio
United States	Southern Illinois Hospital Services	Carterville	Illinois
United States	UNC	Chapel Hill	North Carolina
United States	The Medical University of South Carolina	Charleston	South Carolina
United States	TriHealth Cancer Institute	Cincinnati	Ohio
United States	OhioHealth Reseach Institute	Columbus	Ohio
United States	Cancer Care Specialists of Illinois	Decatur	Illinois
United States	Duke University	Durham	North Carolina
United States	Mercy Clinic Oncology - Fort Smith	Fort Smith	Arkansas
United States	MemorialCare	Fountain Valley	California
United States	Southeastern Medical Oncology Center (SMOC)	Goldsboro	North Carolina
United States	Hope and Healing Cancer Services	Hinsdale	Illinois
United States	Hawaii Cancer Care	Honolulu	Hawaii
United States	Community Health Network	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Cayuga Medical Center	Ithaca	New York
United States	Mercy Clinic Oncology and Hematology - Joplin	Joplin	Missouri
United States	Gundersen Health System	La Crosse	Wisconsin
United States	OptumCare Cancer Care	Las Vegas	Nevada
United States	Cancer and Blood Specialty Clinic	Los Alamitos	California
United States	Baptist Cancer Center	Memphis	Tennessee
United States	Eastern CT and Hematology and Oncology Associates	Norwich	Connecticut
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	Mercy Clinic Oncology and Hematology - Coletta	Oklahoma City	Oklahoma
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	Lake Regional Health System	Osage Beach	Missouri
United States	Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center	Saint Louis	Missouri
United States	Mercy Clinic Oncology and Hematology - Sindelar Cancer Center	Saint Louis	Missouri
United States	Oregon Oncology Specialists	Salem	Oregon
United States	Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center	Springfield	Missouri
United States	Oncology Hematology Associates	Springfield	Missouri
United States	Oklahoma Cancer Specialists and Research Institute	Tulsa	Oklahoma
United States	Cancer Care Associates of York	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Tempus AI	AstraZeneca

Country where clinical trial is conducted

United States, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival	The duration of time between enrollment and death for any reason	2 years or until the patient is reported deceased, whichever came first
Other	Lead Time	Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.	2 years
Primary	Recurrence-Free Survival	Recurrence-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic recurrence or death	2 years
Primary	Progression-Free Survival	Progression-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic progression or death	2 years
Secondary	Sensitivity	Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected.	2 years
Secondary	Specificity	Specificity defined as the proportion of participants who do not develop recurrence who do not have ctDNA detected at or before the time of clinical detection of recurrence.	2 years
Secondary	Positive Predictive Value	Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur.	2 years