Carcinoma, Non-Small-Cell-Lung Cancer
Conditions
Brief summary
Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. The exploration of new drugs and regimens are warranted. Therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage IB, IIA-B, IIIA.
Interventions
DRUGGemcitabine
DRUGcisplatin
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* define histologic or cytologic diagnosis of non small cell lung cancer. * determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer. * define performance status of 0-1 on ECOG scale * do not have any prior tumor therapy * to be suitable for curative resection
Exclusion criteria
* to have any treatment within the last 30 days with any investigational drug. * to get concurrent administration of any other tumor therapy * to be pregnant * to have poorly controlled diabetes mellitus * to have serious concomitant disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of neo-adjuvant chemotherapy with gemcitabine / cisplatin | — |
| To determine the complete tumor resection rate | — |
| To evaluate overall survival and time to documented disease progression | — |
Countries
Turkey (Türkiye)
Outcome results
None listed