409 Participants Needed

Screening for Lung Cancer

Recruiting at 9 trial locations
DG
BP
PI
Overseen ByPuneeth Iyengar, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
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 aims to determine if individuals with unexplained weight loss are more likely to have lung cancer compared to those without such symptoms. Participants will undergo a special type of CT scan, known as LDCT, which uses low radiation to capture detailed images of the lungs to help identify tumors. Researchers will also analyze blood samples to assess their potential in diagnosing lung cancer. This trial suits individuals with a history of smoking, experiencing unexplained weight loss, and who have not had a recent CT scan of their chest. As a Phase 2 trial, this research measures the effectiveness of the diagnostic approach in an initial, smaller group, allowing participants to contribute to early-stage advancements in lung cancer detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that low-dose CT imaging is safe for lung cancer screening?

Research has shown that using low-dose CT scans to screen for lung cancer is generally safe. Studies have found that this method significantly reduces deaths from lung cancer. The scans use a small amount of radiation to take detailed pictures of the lungs, helping doctors find tumors early.

The U.S. Preventive Services Task Force (USPSTF) recommends this screening for adults at higher risk, such as those with a history of heavy smoking. For many, the benefits of screening outweigh the risks.

Although radiation exposure carries some risk, the amount used in these CT scans is very low. No unusual or severe side effects have been widely reported with this type of screening. It is a well-accepted method for checking lung health in at-risk individuals.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to lung cancer screening, particularly for individuals experiencing unexplained weight loss. Unlike traditional methods that rely solely on imaging like chest X-rays, this study uses annual low-dose CT (LDCT) scans to potentially catch cancer earlier. Additionally, the trial includes the innovative step of collecting biospecimens for circulating tumor DNA (ctDNA) analysis, which could provide insights into the genetic profile of tumors. This dual approach not only aims to improve early detection but also offers a glimpse into the future of personalized cancer screening.

What evidence suggests that lung cancer screening with low-dose CT imaging is effective for detecting lung cancer?

Research has shown that low-dose CT (LDCT) scans effectively detect lung cancer early. Studies have found that LDCT can identify lung cancer in its initial stages, when treatment is often easier. One study found a detection rate of 3.7%, discovering cancers that might have been missed otherwise. Another study demonstrated that LDCT accurately identifies people with lung cancer, with a success rate of 97%. This screening method significantly reduces the risk of dying from lung cancer by enabling early treatment. Participants in this trial will undergo annual LDCT imaging as part of the study.13456

Who Is on the Research Team?

PI

Puneeth Iyengar, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 50 and 80 years old.
I have smoked at least 20 packs of cigarettes a year.
My weight has been recorded in my medical records at enrollment and about a year before that.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lung Cancer Screening

Participants undergo low-dose computed tomography (LDCT) imaging to screen for lung cancer

2 years
Annual visits for LDCT imaging

Biospecimen Collection

Blood samples are collected for post-hoc ctDNA analysis at baseline and Year 1

Baseline and Year 1

Follow-up

Participants are monitored for the incidence of lung cancer over the study period

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Lung Cancer Screening with Low Dose CT imaging

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Patients undergoing Lung cancer screeningExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

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

Citations

Lung cancer screening with low-dose CT: a world-wide view

Twenty-one lung cancers were detected by screening, for a yield of 3.7% (21/561); 16 of these were seen at baseline and 5 first seen on follow-up scans. Of the ...

Review Current evidence of low-dose CT screening benefit

LDCT screening has emerged as a powerful tool for early detection, enabling diagnosis at curable stages and reducing lung cancer mortality.

Low-dose CT for lung cancer screening in a high-risk ...

At 12 months, the episode sensitivity of our low-dose CT screening protocol for detecting lung cancer was 97·0% (95% CI 95·0–99·1; 261 of 269 ...

Reduced Lung-Cancer Mortality with Low-Dose Computed ...

A total of 96.4% of the positive screening results in the low-dose CT group and 94.5% in the radiography group were false positive results. The ...

Screening for Lung Cancer with Low Dose Computed ...

Use this page to view details for the decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N).

Recommendation: Lung Cancer: Screening

The USPSTF recommends annual screening for lung cancer with LDCT in adults aged 50 to 80 years who have at least a 20 pack-year smoking history.