Non Small Cell Lung Cancer Clinical Trial
Official title:
Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic NSCLC
The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.
The primary objective of this study was to assess the efficacy in terms of overall survival
(OS) of AZD6244 in combination with docetaxel, compared with docetaxel alone, in second-line
patients with KRAS mutation-positive locally advanced or metastatic NSCLC. Amendment 4 of the
CSP altered the primary objective and outcome variable from progression-free survival (PFS)
to OS, and the secondary outcome variable changed from OS to PFS.
The secondary objectives of the study were:
- To further assess the efficacy of AZD6244 in combination with docetaxel, compared with
docetaxel alone, in second-line patients with KRAS mutation-positive locally advanced or
metastatic NSCLC
- To assess the safety and tolerability profile of AZD6244 in combination with docetaxel
- To investigate the use of plasma and serum as a potential source of circulating free
tumour DNA (cfDNA) for the analysis of KRAS mutation status
- To investigate the PK of AZD6244 and N-desmethyl AZD6244 and any other known metabolites
when AZD6244 is administered in combination with docetaxel.
The exploratory objectives of the study were:
- To assess the prevalence, severity and change over time of advanced NSCLC cancer
specific symptoms in patients receiving AZD6244 in combination with docetaxel and
docetaxel alone
- To explore potential biomarkers in residual tumour, plasma and/or serum taken for KRAS
mutational analysis which may influence development of NSCLC (and associated clinical
characteristics) and/or response (optional)
- To investigate the relationship between AZD6244 and/or N-desmethyl AZD6244 and any other
known metabolite plasma concentrations or exposure and clinical outcomes, efficacy, AEs,
and/or safety parameters if deemed appropriate
- To collect and store deoxyribonucleic acid (DNA), derived from a blood sample, for
future exploratory research into genes that may influence response, eg, distribution,
safety, tolerability, and efficacy of AZD6244 and/or agents used in combination and/or
as comparators (optional).
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