Spots Global Cancer Trial Database for TS Stratified Chemotherapy and VEGF Inhibition in Non-Squamous Non-Small Cell Lung Cancer - Stage IV

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: TS Stratified Chemotherapy and VEGF Inhibition in Non-Squamous Non-Small Cell Lung Cancer - Stage IV

Official Title: TS Stratified Chemotherapy and VEGF Inhibition in Non-Squamous Non-Small Cell Lung Cancer - Stage IV

Study ID: NCT01674738

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

Cisplatin

Bevacizumab

Study Description

Brief Summary: This study wants to determine the activity of a first-line treatment related to Thymidylate Synthetase (TS) Expression. Patients with the diagnosis of non-squamous advanced Non-Small-Cell Lung-Cancer (Stage IV) and without evidence of EGFR mutation may be enclosed in this clinical trial.

Detailed Description: During the screening procedure tumour specimens obtained by primary biopsy, will be analysed for EGFRmut and immunohistochemically for thymidylate synthetase (TS) expression. Employing the H-Score with a cut-off of 150, EGFR-wt patients will be stratified into a TS low (Stratum A) and TS high (Stratum B) group. This procedure is aiming to provide two equally sized strata. After stratification according to the TS expression level patients will be treated with a combination of Pemetrexed, Cisplatin and Bevacizumab. Pemetrexed/Cisplatin/Bevacizumab will be administered for a maximum of 4 cycles. Patients with a complete response (CR), partial response (PR) or stable disease (SD) will continue on maintenance therapy of Pemetrexed and Bevacizumab until disease progression or unacceptable toxicity. * Duration of treatment/patient: up to 1,5 years * Follow Up: at least 6 month * Planned number of patients: 146 treated patients