Clinical trial · Interventional
Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer
A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG
- 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)
Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
| Adenosquamous Cell Lung Cancer | — | UNRESOLVED | — |
| Bronchoalveolar Cell Lung Cancer | — | UNRESOLVED | — |
| Large Cell Lung Cancer | Lung Large Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Lung Cancer | Lung Squamous Cell Carcinoma | ALIAS | 0.90 |
| Stage IB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (surgery, observation)
- description
- Patients receive no further therapy.
- interventionNames
- Procedure: therapeutic conventional surgery
- type
- EXPERIMENTAL
- label
- Arm II (surgery, chemotherapy)
- description
- Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.
- interventionNames
- Drug: paclitaxel
- Drug: carboplatin
- Procedure: therapeutic conventional surgery
Primary outcomes (2)
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented non-small cell carcinoma * Completely resected T2N0M0 Stage I NSCLC as defined by the International Staging System * Surgery shall consist of a lobectomy or pneumonectomy with resection of associated N1 lymph nodes (either by thoracotomy or thoracoscopy) * Patients must be randomized within 4 to 8 weeks from the date of complete surgical resection * No prior chemotherapy or radiation for non-small cell lung cancer * Performance status of 0 or 1 * Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study * Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has bee disease free for five years * Granulocytes \>= 1,800/ul * Platelets \>= 100,000/ul * Bilirubin \< 1.5 mg/dl * SGOT (AST) \< 2.0 x ULN
References
Publications (0)
Data not yet available