Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

Conditions

• Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Selumetinib 75 mg — DRUG
  Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.
• Docetaxel 75 mg/m2 — DRUG
  Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
• Docetaxel 60 mg/m2 — DRUG
  Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
• Placebo — DRUG
  Three placebo capsules will be administered orally uninterrupted twice daily.

Study Details

The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

Key Dates

Start date

Dec 18, 2012

Status verified

Oct 2023

Primary completion

Jan 27, 2016

Completion

Oct 31, 2022

Study Design

Enrollment

212 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2
  Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
• Experimental: Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2
  Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 60 mg/m2 intravenously administered on day 1 of each 21 day cycle.
• Experimental: Placebo twice daily + Docetaxel 75 mg/m2
  Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis) ]

Locations (13)

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