Clinical trial · Interventional
Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 cm) Peripheral Non-Small Cell Lung Cancer
NCT00499330CI-TRIAL-00118120active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lobectomy | Procedure | — | UNRESOLVED |
| segmentectomy or wedge resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm A
- description
- Patients undergo a standard operation for lung cancer called a lobectomy.
- interventionNames
- Procedure: lobectomy
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.
- interventionNames
- Procedure: segmentectomy or wedge resection
Primary outcomes (1)
- measure
- disease-free survival
- timeFrame
- Up to 7 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- DERIVEDGanti 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. PMID 42501610
- DERIVEDAltorki 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. PMID 40532782
- DERIVEDStinchcombe 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. PMID 38215351
- DERIVEDAltorki 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. PMID 36780674
- DERIVEDAltorki 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.