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

Intergroupe Francophone de Cancerologie Thoracique

Status and phase: Completed; Phase 2

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

Treatments: Drug: Cisplatin; Drug: Pemetrexed; Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01705184

IFCT-1102

2012-002647-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

BUCiL

Experimental group

Description:

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

Treatment:

Drug: Bevacizumab

Drug: Cisplatin

Drug: Pemetrexed