Non-small Cell Lung Cancer Metastatic, Nonsquamous Nonsmall Cell Neoplasm of Lung
Conditions
Keywords
Stop and go, Non-small cell lung cancer, Non-squamous, Bevacizumab, IFCT
Brief summary
At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression. In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological. The question is to know if this strategy is feasible in lung cancer.
Interventions
DRUGCisplatin
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence
DRUGBevacizumab
7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence
DRUGPemetrexed
500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles for the 1st sequence and until progression for the 2nd sequence.
Sponsors
Intergroupe Francophone de Cancerologie Thoracique
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation. * Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic. * Measurable disease (recist criteria) * Age ≥18 years * PS0 or 1
Exclusion criteria
* Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer * History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years. * Tumor invaded the big vessels or the proximal visible in TDM. * History of adjuvant or neoadjuvant chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | After 3 cycles | Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence |
Secondary
| Measure | Time frame |
|---|---|
| Control rate after the 2nd sequence | After 3 cycles |
| Response rate after the 1st sequence | After 3 cycles |
| Overall survival | 12 months |
| Quality of life | During Sequence 2 : at the beginning and after 3 cycles |
Countries
France
Outcome results
None listed