1200 Participants Needed

Observation for Non-Small Cell Lung Cancer

Recruiting at 57 trial locations
GD
NS
GN
Overseen ByGEMINI NSCLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how lung cancer changes over time and how a blood test might predict the risk of cancer returning or assess treatment effectiveness. It focuses on patients with non-small cell lung cancer (NSCLC). The trial includes two groups: one with early-stage cancer considering surgery and another with advanced-stage cancer receiving immunotherapy, which helps the immune system fight cancer. Patients with NSCLC receiving these treatments may be suitable candidates, especially if they agree to extra blood tests during check-ups. One approach under study is Observation (also known as Watchful waiting or Active surveillance), which involves closely monitoring a patient's condition without treatment unless test results change. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on collecting health information and blood samples while you continue your standard care.

Why are researchers excited about this trial?

Researchers are excited about the GEMINI-NSCLC trial because it aims to refine and personalize treatment approaches for non-small cell lung cancer (NSCLC) by examining important biomarkers. Unlike standard treatments, which often follow a one-size-fits-all approach, this trial seeks to understand how different patients respond to surgery, perioperative therapy, or first-line immunotherapy. By observing and analyzing patient data, researchers hope to improve treatment outcomes by identifying which therapies work best for specific patient profiles. This could lead to more effective and tailored treatment strategies, potentially improving survival rates and quality of life for NSCLC patients.

Who Is on the Research Team?

VR

Virginia Rhodes, MD

Principal Investigator

Tempus AI, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

I might have lung cancer that can be surgically removed and I agree to a diagnostic procedure.
My cancer treatment follows standard guidelines, regardless of genetic changes.
I am willing and able to agree to participate in the study.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard of Care Therapy

Participants receive standard of care therapy, including surgery and/or immunotherapy, with longitudinal blood collection

Varies based on individual treatment plans

Disease Surveillance

Participants undergo regular monitoring to assess disease progression and molecular changes

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Observation
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Group II: Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tempus AI

Lead Sponsor

Trials
18
Recruited
20,700+

Tempus Labs

Lead Sponsor

Trials
17
Recruited
20,200+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

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