Clinical trial · Interventional
Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer
- 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: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I, stage II, or stage III 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 |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm Trial
- description
- adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
- interventionNames
- Drug: carboplatin
- Drug: docetaxel
Primary outcomes (1)
- measure
- Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
- timeFrame
- 12 weeks from initiating adjuvant therapy
- description
- Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically confirmed non-small cell lung cancer * Stage I-IIIA disease * Must have undergone a complete resection * Must begin adjuvant chemotherapy within 8 weeks of surgical resection PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 100,000/mm\^3 * Serum creatinine normal OR creatinine clearance ≥ 40 mL/min * Bilirubin normal * Alkaline phosphatase (AP), Aspartate aminotransferase (AST), and Alanine transaminase (ALT) must meet 1 of the following criteria: * AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST and ALT normal * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study therapy Exclusion criteria: * Patients with a history of severe hypersensitivity to docetaxel or polysorbate 80 are excluded. * Women who are currently or planning to breast feed. * Those with peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: * 2-8 weeks since prior surgery and recovered
References
Publications (1)
- RESULTStinchcombe TE, Harper HD, Hensing TA, Moore DT, Crane JM, Atkins JN, Willard EM, Detterbeck FC, Socinski MA. The feasibility of adjuvant carboplatin and docetaxel in patients with curatively resected non-small cell lung cancer. J Thorac Oncol. 2008 Feb;3(2):145-51. doi: 10.1097/JTO.0b013e318160c5f1. PMID 18303435