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LUX-Lung 5: BIBW 2992 Plus Weekly Paclitaxel Versus Investigator's Choice of Single Agent Chemotherapy Following BIBW 2992 Monotherapy in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib

2014-08-27 03:15:18 | BioPortfolio

Summary

The primary objective of this randomized, open-label, active-controlled, multi-center trial is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up. Additional information on the health-related quality of life (HRQOL) will be collected.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention

BIBW 2992, Investigator´s choice of chemotherapy

Location

1200.42.01028 Boehringer Ingelheim Investigational Site
Tucson
Arizona
United States

Status

Recruiting

Source

Boehringer Ingelheim Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:18-0400

Clinical Trials [4074 Associated Clinical Trials listed on BioPortfolio]

Trial Exploring BIBW 2992 + Paclitaxel (Part A) and BIBW 2992 + Paclitaxel + Bevacizumab (Part B) in Patients With Advanced Solid Tumours

The main purpose of this study is to assess the optimum dose of the following medications when they are given together: - BIBW 2992 and paclitaxel (Taxol) - BIBW 2992 and p...

Trial of BIBW 2992 + Cetuximab in Non-Small Cell Lung Cancer

The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for the combination of BIBW 2992 and cetuximab in patients with non-smal...

BIBW 2992 Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. T...

BIBW 2992 With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma

Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992 administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade I...

BIBW 2992 QTcF Trial in Patients With Relapsed or Refractory Solid Tumours

A phase II trial to assess the impact of BIBW 2992 on the heart (QTcF) and the effectiveness of BIBW 2992 in treating certain cancers. Cancers studied will include glioblastoma and cancers...

PubMed Articles [25004 Associated PubMed Articles listed on BioPortfolio]

Molecular mechanisms of chemoresistance in head and neck squamous cell carcinoma.

Head and neck squamous cell carcinoma (HNSCC) is an aggressive neoplasm with the properties of local recurrence and distant metastasis. Currently, cisplatin-based chemotherapy or concurrent radiochemo...

Primary ovarian small cell carcinoma of pulmonary type with coexisting endometrial carcinoma in a breast cancer patient receiving tamoxifen: A case report and literature review.

Small cell carcinoma of the ovary (SCCO) is a rare and aggressive extra-pulmonary variant of small cell tumors of uncertain histogenesis. The pathogenesis and optimal treatment of SCCO is unclear. We ...

Health-Related Quality-of-Life Analysis From KEYNOTE-045: A Phase III Study of Pembrolizumab Versus Chemotherapy for Previously Treated Advanced Urothelial Cancer.

Purpose In the phase III KEYNOTE-045 study ( ClinicalTrials.gov identifier: NCT02256436), pembrolizumab significantly prolonged overall survival compared with investigator's choice of chemotherapy in ...

Polymetastatic highly aggressive Small Cell Undifferentiated Neuroendocrine Carcinoma of Ascending Colon.

Neuroendocrine carcinoma (NEC) of the colon is a rare and very aggressive tumor with poor prognosis. The current case report presents a 53-year-old male with a 6 cm × 10 cm ascending colon carcinoma,...

Histological changes of superficial esophageal squamous cell carcinoma after preoperative chemotherapy.

We aimed to analyze the clinical and histological effects of chemotherapy in superficial esophageal squamous cell carcinoma (SESCC).

Medical and Biotech [MESH] Definitions

A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).

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.

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

An anaplastic, highly malignant, and usually bronchogenic carcinoma composed of small ovoid cells with scanty neoplasm. It is characterized by a dominant, deeply basophilic nucleus, and absent or indistinct nucleoli. (From Stedman, 25th ed; Holland et al., Cancer Medicine, 3d ed, p1286-7)

A group of carcinomas which share a characteristic morphology, often being composed of clusters and trabecular sheets of round "blue cells", granular chromatin, and an attenuated rim of poorly demarcated cytoplasm. Neuroendocrine tumors include carcinoids, small ("oat") cell carcinomas, medullary carcinoma of the thyroid, Merkel cell tumor, cutaneous neuroendocrine carcinoma, pancreatic islet cell tumors, and pheochromocytoma. Neurosecretory granules are found within the tumor cells. (Segen, Dictionary of Modern Medicine, 1992)

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