Stage IV Non-small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer ;, metastatic ;, chemotherapy ;, erlotinib
Brief summary
The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival : * Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity. * Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy.
Interventions
DRUGobservation
observation, second line chemotherapy if progression
DRUGgemcitabine
1250 mg/m² D1, D8 q21 days
DRUGerlotinib
150 mg daily
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically documented NSCLC (tumor tissue samples will be provided to look for assessment of EGFR status with CISH, immunochemistry and mutations) : adenocarcinoma, squamous cell carcinoma, large cell carcinoma. A cytological documentation of NSCLC is accepted. * Stage IV disease or metastatic relapse in not previously irradiated areas of a NSCLC previously treated with surgery or radiation therapy (with a histologically documented proof of relapse) or stage III B with documented pleural involvement. * Measurable disease according to the RECIST criteria. * Prior radiotherapy authorized except for irradiation concerning measurable disease. * Age \>18 and \< 70 years. * PS \< 2. * Normal hepatic function : serum bilirubin \< 1.5 ULN, SGOT (ASAT) and SGPT (ALAT) \< 2,5 ULN ; in presence of liver metastases, SGOT and SGPT must be \< 5 x ULN. * Creatinine clearance \> 60 mL/min. * Granulocyte count \> 1,5 giga/L, platelet count \> 100 giga/L. * Life expectancy \> 12 weeks. * Written (signed) informed consent for use of tumors samples. * Written (signed) informed consent to participate in the sudy.
Exclusion criteria
* Small cell lung cancer, bronchiolo-alveolar carcinoma, neuro-endocrine carcinoma. * PS \> 1. * Prior chemotherapy other than cisplatin-gemcitabine. * Prior therapy with EGFR inhibitor (e.g. monoclonal antibody). * No concomitant therapy with phenytoin, carbamazepine, rifampicine or phenobarbital. * Concomitant radiotherapy except for localized bone irradiation. * Symptomatic brain metastases. * Superior vena cava syndrome. * Any unstable systemic disease : significant cardiovascular disease including myocardial infarction within the previous year, active infection, significant hepatic or renal disease. * Pre-existing interstitial lung disease. * Any inflammatory changes of the surface of the eyes. * Psychiatric disease with inability to understand the study or to comply with follow-up procedures. * Grade \> or = 2 peripheral neuropathy. * Any other malignancies within 5 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer). * Pregnant or lactating women ; patients with reproductive potential must use effective contraception. * Inability to comply with follow-up procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival since randomization | time until progression |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, | no time limit |
| toxicity (NCIC-CTC 3.0), | time until progression |
| quality of life (as assessed by LCSS). | until progression |
Countries
France
Outcome results
None listed