CClinicalTrials.gg
Active, not recruitingNCT00499330Updated Jul 16, 2026

Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

An interventional study of lobectomy and segmentectomy or wedge resection in Lung Cancer, sponsored by Alliance for Clinical Trials in Oncology. Active, not recruiting at 386 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Alliance for Clinical Trials in Oncology · Interventional

Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.

Read the detailed description

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to tumor size (\< 1 cm vs 1-1.5 cm vs > 1.5-2.0 cm) (based on the maximum dimension determined from the preoperative CT scan), histology (squamous cell carcinoma vs adenocarcinoma vs other), and smoking status (never smoked [smoked \< 100 cigarettes over lifetime] vs former smoker [smoked > 100 cigarettes AND quit ≥ 1 year ago] vs current smoker [quit \< 1 year ago or currently smokes]). Patients are randomized to 1 of 2 treatment arms. For more information, please see the Arms section.

Primary Objective:

To determine whether DFS after sublobar resection (segmentectomy or wedge) is non-inferior to that after lobectomy in patients with small peripheral (≤ 2 cm) NSCLC.

Secondary Objectives:

  1. To determine whether overall survival (OS) (after sublobar resection) is non-inferior to that after lobectomy.
  2. To determine the rates of loco-regional and systemic recurrence (exclusive of second primaries) after lobar and sublobar resection.
  3. To determine the difference between the two arms of the study in pulmonary function as determined by expiratory flow rates measured at 6 months post-operatively.
  4. Imaging Substudy: To explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT and PET imaging, and outcomes; a determination of the false-negative rate of the pre-operative PET scan for identification of involved hilarand mediastinal lymph nodes; and an assessment of the utility of annual follow-up CT imaging after surgical resection of small stage IA NSCLC.

After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 5 years.

02

Conditions studied

  • Lung Cancer

Keywords

  • stage IA non-small cell lung cancer
  • adenocarcinoma of the lung
  • squamous cell lung cancer
  • large cell lung cancer
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

Browse Lung Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Pre-registration Eligibility Criteria:

  1. Peripheral lung nodule ≤ 2 cm on preoperative CT scan and presumed to be lung cancer. The center of the tumor, as seen on CT, must be located in the outer third of the lung in either the transverse, coronal or sagittal plane. Patients with pure ground glass opacities or pathologically confirmed N1 or N2 disease are not eligible.
  2. The tumor location must be suitable for either lobar or sublobar resection (wedge or segment).
  3. ECOG performance status of 0-2.
  4. No prior malignancy within 3 years other than non-melanoma skin cancer, superficial bladder cancer, or CIS of the cervix.
  5. No prior chemotherapy or radiation therapy for this malignancy.
  6. No evidence of locally advanced or metastatic disease.
  7. Age ≥ 18 years

Intra-operative Randomization Eligibility Criteria:

  1. Histologic confirmation of NSCLC (if not already obtained)
  2. Confirmation of N0 status by frozen section examination. Right sided tumors require that node levels 4, 7, and 10 be sampled and diagnosed as negative on frozen section. Left sided tumors require that node levels 5 or 6, 7 and 10 be sampled and diagnosed as negative on frozen section. Levels 4 and 7 nodes may be sampled by mediastinoscopy, endobronchial ultrasound (EBUS) and/or endoscopic ultrasound (EUS), or at the time of thoracotomy or VATS exploration. Nodes previously sampled by mediastinoscopy (or EBUS and/or EUS) either immediately prior to or within 6 weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled.
05

Study design

Study arms

  • Other
    Arm A

    Patients undergo a standard operation for lung cancer called a lobectomy.

    Procedure: lobectomy

  • Experimental
    Arm B

    Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.

    Procedure: segmentectomy or wedge resection

Interventions

  • Procedurelobectomy
  • Proceduresegmentectomy or wedge resection
06

What researchers measure

Primary outcomes

  1. disease-free survival

    Time frame: Up to 7 years

Secondary outcomes

  1. overall survival

    Time frame: Up to 7 years

  2. rate of loco-regional and systemic recurrence

    Time frame: Up to 7 years

  3. pulmonary function as measured by expiratory flow rate 6 months postoperatively

    Time frame: at 6 months

07

Study locations

386 sites
  • University of Alabama at Birmingham Cancer Center
    Birmingham, Alabama 35233, United States
  • Anchorage Associates in Radiation Medicine
    Anchorage, Alaska 98508, United States
  • Anchorage Radiation Therapy Center
    Anchorage, Alaska 99504, United States
  • Alaska Breast Care and Surgery LLC
    Anchorage, Alaska 99508, United States
  • Alaska Oncology and Hematology LLC
    Anchorage, Alaska 99508, United States
  • Alaska Regional Hospital
    Anchorage, Alaska 99508, United States
  • Alaska Women's Cancer Care
    Anchorage, Alaska 99508, United States
  • Anchorage Oncology Centre
    Anchorage, Alaska 99508, United States
  • Katmai Oncology Group
    Anchorage, Alaska 99508, United States
  • Providence Alaska Medical Center
    Anchorage, Alaska 99508, United States
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • The University of Arizona Medical Center-University Campus
    Tucson, Arizona 85724, United States
  • Mercy Cancer Center-Hot Springs
    Hot Springs, Arkansas 71913, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Highlands Oncology Group-Rogers
    Rogers, Arkansas 72758, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California 91505, United States
  • Mercy San Juan Medical Center
    Carmichael, California 95608, United States
  • Saint Jude Medical Center
    Fullerton, California 92835, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Veterans Affairs Loma Linda Healthcare System
    Loma Linda, California 92357, United States
  • Veterans Administration Long Beach Medical Center
    Long Beach, California 90822, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • Kaiser Permanente-Riverside
    Riverside, California 92505, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • University of California San Diego
    San Diego, California 92103, United States
  • University of Colorado Cancer Center - Anschutz Cancer Pavilion
    Aurora, Colorado 80045, United States
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado 80907, United States
  • Rocky Mountain Cancer Centers-Penrose
    Colorado Springs, Colorado 80907, United States
  • Memorial Hospital Colorado Springs
    Colorado Springs, Colorado 80909, United States
  • Porter Adventist Hospital
    Denver, Colorado 80210, United States
  • University of Colorado
    Denver, Colorado 80217-3364, United States
  • Mercy Medical Center
    Durango, Colorado 81301, United States
  • Southwest Oncology PC
    Durango, Colorado 81301, United States
  • Mountain Blue Cancer Care Center
    Golden, Colorado 80401, United States
  • Rocky Mountain Cancer Centers-Lakewood
    Lakewood, Colorado 80228, United States
  • Saint Anthony Hospital
    Lakewood, Colorado 80228, United States
  • Littleton Adventist Hospital
    Littleton, Colorado 80122, United States
  • Longmont United Hospital
    Longmont, Colorado 80501, United States
  • Rocky Mountain Cancer Centers-Longmont
    Longmont, Colorado 80501, United States
  • Parker Adventist Hospital
    Parker, Colorado 80138, United States
  • Rocky Mountain Cancer Centers-Parker
    Parker, Colorado 80138, United States
  • Saint Mary Corwin Medical Center
    Pueblo, Colorado 81004, United States
  • Rocky Mountain Cancer Centers - Pueblo
    Pueblo, Colorado 81008, United States
  • Rocky Mountain Cancer Centers-Thornton
    Thornton, Colorado 80260, United States
  • Saint Vincent's Medical Center
    Bridgeport, Connecticut 06606, United States
  • Smilow Cancer Hospital Care Center at Saint Francis
    Hartford, Connecticut 06105, United States
  • Stamford Hospital/Bennett Cancer Center
    Stamford, Connecticut 06904, United States
  • Beebe Medical Center
    Lewes, Delaware 19958, United States
  • Christiana Gynecologic Oncology LLC
    Newark, Delaware 19713, United States
  • Delaware Clinical and Laboratory Physicians PA
    Newark, Delaware 19713, United States
  • Helen F Graham Cancer Center
    Newark, Delaware 19713, United States
  • Medical Oncology Hematology Consultants PA
    Newark, Delaware 19713, United States
  • Regional Hematology and Oncology PA
    Newark, Delaware 19713, United States
  • Christiana Care Health System-Christiana Hospital
    Newark, Delaware 19718, United States
  • Beebe Health Campus
    Rehoboth Beach, Delaware 19971, United States
  • Nanticoke Memorial Hospital
    Seaford, Delaware 19973, United States
  • Christiana Care Health System-Wilmington Hospital
    Wilmington, Delaware 19801, United States
  • Boca Raton Regional Hospital
    Boca Raton, Florida 33486, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
  • Emory University/Winship Cancer Institute
    Atlanta, Georgia 30322, United States
  • Atlanta VA Medical Center
    Decatur, Georgia 30033, United States
  • Memorial University Medical Center
    Savannah, Georgia 31404, United States
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
  • Saint Luke's Mountain States Tumor Institute
    Boise, Idaho 83712, United States
  • Saint Alphonsus Cancer Care Center-Caldwell
    Caldwell, Idaho 83605, United States
  • Kootenai Medical Center
    Coeur d'Alene, Idaho 83814, United States
  • Walter Knox Memorial Hospital
    Emmett, Idaho 83617, United States
  • Saint Luke's Mountain States Tumor Institute - Fruitland
    Fruitland, Idaho 83619, United States
  • Saint Joseph Regional Medical Center
    Lewiston, Idaho 83501, United States
  • Idaho Urologic Institute-Meridian
    Meridian, Idaho 83642, United States
  • Saint Luke's Mountain States Tumor Institute - Meridian
    Meridian, Idaho 83642, United States
  • Saint Alphonsus Medical Center-Nampa
    Nampa, Idaho 83686, United States
  • Saint Luke's Mountain States Tumor Institute - Nampa
    Nampa, Idaho 83686, United States
  • Portneuf Medical Center
    Pocatello, Idaho 83201, United States
  • Kootenai Cancer Center
    Post Falls, Idaho 83854, United States
  • Kootenai Cancer Clinic
    Sandpoint, Idaho 83864, United States
  • Saint Luke's Mountain States Tumor Institute-Twin Falls
    Twin Falls, Idaho 83301, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • Saint John's Hospital
    Springfield, Illinois 62702, United States
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62702, United States
  • Indiana University/Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana 46202, United States
  • Richard L. Roudebush Veterans Affairs Medical Center
    Indianapolis, Indiana 46202, United States
  • Sidney and Lois Eskenazi Hospital
    Indianapolis, Indiana 46202, United States
  • Memorial Regional Cancer Center Day Road
    Mishawaka, Indiana 46544, United States
  • Memorial Hospital of South Bend
    South Bend, Indiana 46601, United States
  • Medical Oncology and Hematology Associates-West Des Moines
    Clive, Iowa 50325, United States
  • Mercy Cancer Center-West Lakes
    Clive, Iowa 50325, United States
  • Alegent Health Mercy Hospital
    Council Bluffs, Iowa 51503, United States
  • Greater Regional Medical Center
    Creston, Iowa 50801, United States
  • Medical Oncology and Hematology Associates-Laurel
    Des Moines, Iowa 50314, United States
  • Mercy Medical Center - Des Moines
    Des Moines, Iowa 50314, United States
  • Mercy Medical Center-West Lakes
    West Des Moines, Iowa 50266, United States
  • University of Kansas Cancer Center
    Kansas City, Kansas 66160, United States
  • Olathe Cancer Center
    Olathe, Kansas 66061, United States
  • Menorah Medical Center
    Overland Park, Kansas 66209, United States
  • Saint Luke's South Hospital
    Overland Park, Kansas 66213, United States
  • Shawnee Mission Medical Center-KCCC
    Shawnee Mission, Kansas 66204, United States
  • Flaget Memorial Hospital
    Bardstown, Kentucky 40004, United States
  • Commonwealth Cancer Center-Corbin
    Corbin, Kentucky 40701, United States

Showing the first 100 of 386 sites across 3 countries.

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References and documents

Publications

  • Ganti AK, Damman B, Wang X, Stinchcombe TE, Altorki N. Outcomes Based on Age in CALGB 140503 (Alliance): Lobar Versus Sublobar Resection for Peripheral Stage IA Non-small Cell Lung Cancer. Clin Lung Cancer. 2026 Jul 2;27(7):42-49. doi: 10.1016/j.cllc.2026.06.009. Online ahead of print. PubMed 42501610 ↗
  • Altorki N, Damman B, Wang X, Liberman M, Wigle D, Ashrafi A, Conti M, Yasufuku K, Schuchert MJ, Stinchcombe TE. The extent of lymph node dissection is not associated with disease-free survival following lobar or sublobar resection: Results from Cancer and Leukemia Group B 140503 (Alliance). J Thorac Cardiovasc Surg. 2025 Oct;170(4):933-942.e2. doi: 10.1016/j.jtcvs.2025.06.007. Epub 2025 Jun 16. PubMed 40532782 ↗
  • Stinchcombe TE, Wang X, Damman B, Mentlick J, Landreneau R, Wigle D, Jones DR, Conti M, Ashrafi AS, Liberman M, de Perrot M, Mitchell JD, Keenan R, Bauer T, Miller D, Altorki N. Secondary Analysis of the Rate of Second Primary Lung Cancer From Cancer and Leukemia Group B 140503 (Alliance) Trial of Lobar Versus Sublobar Resection for T1aN0 Non-Small-Cell Lung Cancer. J Clin Oncol. 2024 Apr 1;42(10):1110-1113. doi: 10.1200/JCO.23.01306. Epub 2024 Jan 12. PubMed 38215351 ↗
  • Altorki N, Wang X, Kozono D, Watt C, Landrenau R, Wigle D, Port J, Jones DR, Conti M, Ashrafi AS, Liberman M, Yasufuku K, Yang S, Mitchell JD, Pass H, Keenan R, Bauer T, Miller D, Kohman LJ, Stinchcombe TE, Vokes E. Lobar or Sublobar Resection for Peripheral Stage IA Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Feb 9;388(6):489-498. doi: 10.1056/NEJMoa2212083. PubMed 36780674 ↗
  • Altorki NK, Wang X, Wigle D, Gu L, Darling G, Ashrafi AS, Landrenau R, Miller D, Liberman M, Jones DR, Keenan R, Conti M, Wright G, Veit LJ, Ramalingam SS, Kamel M, Pass HI, Mitchell JD, Stinchcombe T, Vokes E, Kohman LJ. Perioperative mortality and morbidity after sublobar versus lobar resection for early-stage non-small-cell lung cancer: post-hoc analysis of an international, randomised, phase 3 trial (CALGB/Alliance 140503). Lancet Respir Med. 2018 Dec;6(12):915-924. doi: 10.1016/S2213-2600(18)30411-9. Epub 2018 Nov 12. PubMed 30442588 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00499330
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 11, 2007
Start date
Oct 12, 2007
Primary completion
Apr 4, 2027 (estimated)
Completion
Apr 4, 2027 (estimated)
Last update
Jul 16, 2026

Study contacts

Nasser Altorki, MD
study chair · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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