Ph II Trial of Carboplatin and Pemetrexed With or Without AZD1775 for Untreated Lung Cancer
- Conditions
- Previously Untreated Stage IV Non-Squamous Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02087241
- Lead Sponsor
- AstraZeneca
- Brief Summary
The aim of this study is to combine AZD1775 with standard front-line chemotherapy in subjects with advanced NSCLC.
- Detailed Description
This is a randomised, phase II trial comparing AZD1775 plus pemetrexed and carboplatin followed by maintenance AZD1775 and pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed in patients with previously untreated metastatic non-squamous NSCLC with TP53 mutations. The primary endpoint of the trial is assessment of progression-free survival (PFS).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZD1775 + carboplatin + pemetrexed AZD1775 Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed. AZD1775 + carboplatin + pemetrexed pemetrexed Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed. AZD1775 + carboplatin + pemetrexed carboplatin Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed. Placebo + carboplatin + pemetrexed AZD1775 Matching Placebo Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed. Placebo + carboplatin + pemetrexed carboplatin Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed. Placebo + carboplatin + pemetrexed pemetrexed Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed.
- Primary Outcome Measures
Name Time Method Progression Free Survival 6 months Progression free survival is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.
- Secondary Outcome Measures
Name Time Method Assess the Objective Response Rates in Each Arm Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days) The objective response rate is defined as the number of the subjects with a confirmed best overall response of CR or PR divided by the number of subjects in the Full Analysis Set (FAS) for whom measureable disease is present at baseline
Assess the Disease Control Rate in Each Treatment Arm Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days) the disease control rate is defined as the percentage of FAS subjects with a best overall response of CR, PR or SD).
Assess the Duration of Response in Each Treatment Arm Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days) Duration of response is defined as the time from the date of first documented response until the date of documented progression or any cause death.
Assess Overall Survival in Each Treatment Arm Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days) Overall survival is defined as the time from the date of randomization until death due to any cause.
Trial Locations
- Locations (1)
Research Site
🇺🇸Nashville, Tennessee, United States