Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study Evaluating the Interest of the Re-introduction of Pemetrexed and Platinum (Cisplatin or Carboplatin) With Prolonged Angiogenic Blocking by Bevacizumab in Non Squamous Non Small Cell Lung Cancer of Advanced Stage.

Conditions
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Non-small Cell Lung Cancer Metastatic, Nonsquamous Nonsmall Cell Neoplasm of Lung

Intervention / Treatment
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* Drug: Cisplatin
* Drug: Bevacizumab
* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUCiL<br>Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --> Sequence 2 Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control | Drug: Cisplatin<br>* 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence<br>Drug: Bevacizumab<br>* 7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence<br>Drug: Pemetrexed<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence | After 3 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stop and go, Non-small cell lung cancer, Non-squamous, Bevacizumab, IFCT