Phase 3 N=53,454 Randomized Screening

National Lung Screening Trial (NLST) Screening

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00047385 ↗

Enrolled (actual)

53,454

Serious AEs

0.0%

Results posted

Jul 2012

Primary outcome: Primary: Lung Cancer Deaths — 356; 443 Participants — p=0.004

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: low-dose helical computed tomography (Device); chest radiography (Device)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Lung Cancer Deaths	356; 443	0.004 sig
SECONDARY Deaths From All Causes in All Randomized Participants.	1877; 2000	0.02 sig
SECONDARY Lung Cancer Diagnoses	1060; 941	—
SECONDARY Complications of Diagnostic Evaluation Following a Positive Screening Test.	245; 81	—
SECONDARY T0 (Baseline) Screening Results	7191; 2387; 2695; 785; 16423; 22863	—
SECONDARY T1 Screening Results	6901; 1482; 1519; 429; 16295; 22178	—
SECONDARY T2 Screening Results	4054; 1174; 1408; 361; 18640; 21811	—

Summary

RATIONALE: Effective screening tests should help doctors detect lung cancer early and plan curative treatment. It is not yet known whether low-dose helical computed tomography (LDCT) screening is more effective than chest radiography (CXR) screening in reducing death from lung cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of LDCT scan with that of CXR in screening individuals who are at high risk for developing lung cancer.

Eligibility Criteria

Inclusion Criteria

Age 55-74 years (pack-years = packs per day * years smoked)
30 or more pack-years of cigarette smoking history
Former smokers: quit smoking within the previous 15 years
Ability to lie on the back with arms raised over the head
Signed informed consent form

Exclusion Criteria

Metallic implants or devices in the chest or back, such as pacemakers or Harrington fixation rods
Treatment for, or evidence of, any cancer other than nonmelanoma skin cancer or carcinoma in situ (with the exception of transitional cell carcinoma in situ or bladder carcinoma in situ) in the 5 years prior to eligibility assessment
History of lung cancer
History of removal of any portion of the lung, excluding needle biopsy
Requirement for home oxygen supplementation
Participation in another cancer screening trial
Participation in a cancer prevention study, other than a smoking cessation study
Unexplained weight loss of more than 15 pounds in the 12 months prior to eligibility assessment
Recent hemoptysis
Pneumonia or acute respiratory infection treated with antibiotics in the 12 weeks prior to eligibility assessment
Chest CT examination in the 18 months prior to eligibility assessment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00047385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.