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Cohort 1 for Non-Small Cell Lung Cancer

N/A

Recruiting

Led By Virginia Rhodes, MD

Research Sponsored by Tempus AI

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 3 trial • 356 Patients • NCT00048997

31%

Fatigue (lethargy, malaise, asthenia)

23%

Alopecia

17%

Late RT Toxicity: Other: NOS

11%

Nausea

10%

Anorexia

Late RT Toxicity: Brain: NOS

Headache

Late RT Toxicity: Skin: NOS

Memory loss

Dyspnea (shortness of breath)

Hemorrhage-Other

Ataxia (incoordination)

Mood alteration-depression

Pain-Other

100%

80%

60%

40%

20%

Study treatment Arm

Prophylactic Cranial Irradiation (PCI)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment1 Intervention

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

Group II: Cohort 1Experimental Treatment1 Intervention

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.

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