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Multi-center, open, randomized (parallel) and comparative phase III.
Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.
Arm A: Bevacizumab + pemetrexed
Arm B: Bevacizumab + pemetrexed + carboplatin
- Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous NSCLC by progression free survival
- To assess the efficacy of bevacizumab as measured by overall response rate and overall survival.
- To assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin.
- To assess quality of life by EORTC questionnaire QLQ-C30 and its lung cancer module LC-13
- To assess activity of daily life (iADL) in relation to ECOG performance status prior to study treatment
- To assess patient`s outcome and treatment delivery in relation to the Charlson comorbidity score and the Simplified Comorbidity Score
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Non-squamous Non-small Cell Lung Cancer
Bevacizumab + Pemetrexed, Bevacizumab + Pemetrexed + Carboplatin
Krankenhaus Martha-Maria Halle-Doelau
Martha-Maria Krankenhaus Halle-Dölau gGmbH
Published on BioPortfolio: 2014-08-27T03:19:23-0400
This is a multicenter single arm phase II clinical trial. All eligible patients will receive: Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 ...
Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Patients With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy
The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival time wi...
A Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non Small Cell Lung Cancer
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered w ith one of three planned re...
The primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression.
The purpose of this study is to look for an improvement in progression free survival with the combination of bevacizumab, carboplatin and pemetrexed in patients with newly diagnosed advanc...
Switch maintenance therapy, using alternative agents that were not administered during induction chemotherapy, is a treatment option for advanced non-squamous non-small cell lung cancer (NSCLC). Bevac...
Leptomeningeal metastases (LMs) were devastating metastatic complications of non-small cell lung cancer (NSCLC). Management of LMs relied on conventional therapy but with poor survival, lacking effect...
Pemetrexed/carboplatin combination chemotherapy has shown efficacy as a first-line treatment for advanced non-small-cell lung cancer. However, severe haematotoxicity is often observed during this comb...
Large scale randomized controlled trials have demonstrated that the use of bevacizumab in addition to chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) conveys significant surv...
Cohort G of KEYNOTE-021 (NCT02039674) evaluated the efficacy and safety of pembrolizumab plus pemetrexed-carboplatin (PC) versus PC alone as first-line therapy for advanced nonsquamous NSCLC. At the p...
A guanine-derived ANTINEOPLASTIC AGENT that functions as a NUCLEIC ACID SYNTHESIS INHIBITOR through its binding to, and inhibition of, THYMIDYLATE SYNTHASE.
An anti-VEGF recombinant monoclonal antibody consisting of humanized murine antibody. It inhibits VEGF receptors and prevents the proliferation of blood vessels.
Neoplasms composed of squamous cells of the epithelium. The concept does not refer to neoplasms located in tissue composed of squamous elements.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
Morphological abnormalities of the cervical EPITHELIUM, usually revealed in PAP SMEAR, which do not meet the criteria for squamous CERVICAL INTRAEPITHELIAL NEOPLASIA or SQUAMOUS CELL CARCINOMAS of the CERVIX . It may be a sign of infection with certain types of human papillomavirus (HPV).or sign of a benign (not cancer) growth, such as a cyst or polyp or, in menopausal women, of low hormone levels. More testing, such as HPV test, may be needed.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
GILOTRIF (afatinib) is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L8...