18 Years
N/A
Both
Non-small Cell Lung Carcinoma
Trial Information
Inclusion Criteria:
1. Histologically confirmed unresectable advanced or metastatic non-small cell lung
cancer (NSCLC) (stage IIIB or IV)
2. Chemotherapy naïve patient (Previous adjuvant or neoadjuvant chemotherapy allowed if
the last dose was administered equal to or greater than 6 months ago.)
3. Age > 18
4. Performance status 0 to 2 by Eastern Cooperative Oncology Group (ECOG) criteria
5. At least one measurable lesion by Response Evaluation Criteria In Solid Tumors
(RECIST)
6. Adequate organ functions (assessed within 14 days of starting treatment) 1) Bone
marrow: Absolute neutrophil count ≥ 1,500/mm³, Platelet count ≥ 100,000/mm³,
Hemoglobin ≥ 9.0 mg/dL 2) Liver: Total bilirubin ≤ 1.5 x ULN; aspartic transaminase
(AST) and alanine transaminase (ALT), alkaline phosphatase(ALP) ≤ 2.5 x ULN 3)
Kidney: Serum creatinine ≤ 1.5 x ULN
7. Signed informed consent document
Exclusion Criteria:
1. Clinically significant serious illness or medical condition (infection)
2. Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
3. Presence of uncontrolled brain or leptomeningeal metastases
4. Prior radiotherapy within 3 weeks of starting treatment
5. Peripheral neuropathy equal to or greater than grade 2 by Common Terminology Criteria
for Adverse Events (CTCAE) v4.0
6. Pregnant or lactating
7. Absolute contraindication of corticosteroid use
8. Patients with a history of severe hypersensitivity reaction to docetaxel,
carboplatin, vinorelbine or gemcitabine
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall Response Rate
Outcome Description:
ORR was assessed by tumor response evaluation according to RECIST 1.1 at every 8 weeks. Tumor assessments will continue about every 8 weeks until disease progression or initiation of subsequent anticancer treatment. (If PR or CR was first documented, confirmation assessment was done between 4 weeks and 8 weeks)
Outcome Time Frame:
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Safety Issue:
No
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
4-2008-0132
NCT ID:
NCT01648517
Start Date:
July 2012
Completion Date:
July 2015
Related Keywords:
- Non-Small Cell Lung Carcinoma
- on-small cell lung carcinoma
- chemotherapy naive patient
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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