NCT01674738

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Aktion Bronchialkarzinom e.V. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Pemetrexed	500 mg/m2 i.v. on day 1 (three-week cycle)
DRUG	Cisplatin	75 mg/m2 i.v. on day 1 (three-week cycle)
DRUG	Bevacizumab	7,5 mg/kg i.v. on day 1 (three-week cycle)

Timeline

• First posted: 2012-08-29
• Last updated: 2013-10-11