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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer Metastatic, Nonsquamous Nonsmall Cell Neoplasm of Lung

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility

Outcome Description:

Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence

Outcome Time Frame:

After 3 cycles

Safety Issue:

Yes

Principal Investigator

Jaafar BENNOUNA, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre René Gauducheau - Nantes

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

IFCT-1102

NCT ID:

NCT01705184

Start Date:

October 2012

Completion Date:

April 2014

Related Keywords:

  • Non-small Cell Lung Cancer Metastatic
  • Nonsquamous Nonsmall Cell Neoplasm of Lung
  • Stop and go
  • Non-small cell lung cancer
  • Non-squamous
  • Bevacizumab
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms, Second Primary

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