Previously Untreated Stage IV Non-Squamous Non Small Cell Lung Cancer Clinical Trial
Official title:
Double-Blind Randomised Phase II Trial of Carboplatin and Pemetrexed With or Without AZD1775 in Patients With Previously Untreated Stage IV Non-Squamous Non-Small-Cell Lung Cancer
| Verified date | June 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The aim of this study is to combine AZD1775 with standard front-line chemotherapy in subjects with advanced NSCLC.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria - Provision of informed consent prior to any study specific procedures - Histologic or cytologic diagnosis of advanced NSCLC, Recurrent or Stage IV disease (according to American Joint Committee on Cancer (AJCC) staging system, v7.0). - No prior chemotherapy for locally advanced or metastatic disease - Subjects with a known EGFR mutation must have received previous treatment with an EGFR tyrosine kinase inhibitor; and subjects with a known ALK translocation must have received previous treatment with an ALK inhibitor. - No prior radiation therapy to the whole pelvis or to =25% of the total bone marrow area. - At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 - Mandatory availability of tumour tissue (archival or fresh if archival is not available) for TP53 determination. - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1. - Absolute neutrophil count (ANC) =1500/µL - Hemoglobin (Hgb) =10 g/dL - Platelets =100,000/µL - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST), =3.0 x the upper limit of normal (ULN); 5 x ULN if known hepatic metastases - Total bilirubin =1.5 x ULN, unless secondary to Gilbert's disease - Serum creatinine =1.5 x ULN and a calculate creatinine clearance (CrCl) =45 mL/min by the Cockcroft-Gault method - Ability to swallow oral medication - Fertile male subjects willing to use at least one medically acceptable form of birth control for the duration of the study and for 2 weeks after treatment stops - Female subjects who are not of childbearing potential and fertile female subjects of childbearing potential who agree to use adequate contraceptive measures who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment - Predicted life expectancy =12 weeks - Must be =18 years of age - Willingness and ability to comply with study and follow-up procedures - Ability to understand the nature of this trial and give written informed consent Exclusion criteria - Use of a study drug =21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775 - Major surgical procedures =28 days of beginning AZD1775, or minor surgical procedures =7 days - Known central nervous system (CNS) disease - Subject has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be sensitive CYP3A4 substrates - Any known hypersensitivity or contraindication to the components of study treatment - Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association ([NYHA] Appendix G) = Class 2 - Corrected QT interval (QTc) >470 msec (as calculated by Fridericia correction formula) at study entry or congenital long QT syndrome. - Pregnant or lactating - Any serious, active underlying medical condition that would impair the ability of the subjects to receive study treatment - Unable or unwilling to take folic acid or vitamin B12 - Presence of other active cancers, or history of treatment for invasive cancer =3 years - Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Englewood | Colorado |
| United States | Research Site | Fort Myers | Florida |
| United States | Research Site | Fort Wayne | Indiana |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Peoria | Illinois |
| United States | Research Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival | 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. | 6 months | No |
| Primary | Progression Free Survival | 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. | 12 months | No |
| Secondary | Assess the objective response rates in each arm | 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 | Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days) | No |
| Secondary | Assess the disease control rate in each treatment arm | the disease control rate is defined as the percentage of FAS subjects with a best overall response of CR, PR or SD). | Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days) | No |
| Secondary | Assess the duration of response in each treatment arm | 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. | Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days) | No |
| Secondary | Evaluate safety in each treatment arm | Safety profiles will be assessed in terms of AEs and laboratory data, vital signs, and ECG data that will be collected for all subjects. | Up to disease progression or unacceptable toxicity (there is no time limit on the length of treatment | Yes |
| Secondary | Assess overall survival in each treatment arm | Overall survival is defined as the time from the date of randomization until death due to any cause. | Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days) | No |