Spots Global Cancer Trial Database for Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC

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Trial Identification

Brief Title: Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC

Official Title: Phase I Study of Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC

Study ID: NCT03611738

Conditions

Non-small Cell Lung Cancer

Lung Cancer

Non-small Cell Lung Cancer Metastatic

Non-small Cell Lung Cancer Stage IIIB

Stage IV Non-small Cell Lung Cancer

EGFR Negative Non-Small Cell Lung Cancer

Interventions

Ceritinib

Docetaxel

Study Description

Brief Summary: The main purpose of this study is to find out what effects (good and bad) ceritinib (Zykadia®) used in combination with docetaxel (Taxotere®) will have on participants and their cancer. The results will help to determine the best safe dose of the combination of the medications Ceritinib (Zykadia®) and docetaxel (Taxotere®) and to find out if this combination of drugs will help people that have this type of Non-small Cell Lung Cancer (NSCLC).

Detailed Description: In this phase I/IB clinical trial, participants with non-small cell lung cancer (NSCLC) who have progressed on prior platinum-based chemotherapy (maximum number of prior distinct regimens = 2) and are anaplastic lymphoma kinase (ALK)-negative/epidermal growth factor receptor (EGFR) wild-type (WT) will receive a combination of ceritinib and docetaxel. Study rationale is that targeting ALK- and EGFR-negative lung tumors with ceritinib and microtubule inhibitors results in synergistic antitumor effects. Therefore, treatment with ceritinib and docetaxel is a rational combination.