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TerminatedPhase 2NCT02087241
Official study title

Ph II Trial of Carboplatin and Pemetrexed With or Without AZD1775 for Untreated Lung Cancer

Study summary

The aim of this study is to combine AZD1775 with standard front-line chemotherapy in subjects with advanced NSCLC.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAZD1775 and AZD1775 Matching Placebo

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 29, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
AstraZeneca
Interventions being studied
Drug: AZD1775; Drug: AZD1775 Matching Placebo; Drug: pemetrexed; Drug: carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteEnglewood, Colorado
  • Research SiteFort Myers, Florida
  • Research SiteOrlando, Florida
  • Research SitePeoria, Illinois
  • Research SiteFort Wayne, Indiana
  • Research SiteWichita, Kansas
  • Research SiteCincinnati, Ohio
  • Research SiteNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 29, 2017. Always confirm current availability with the study team.

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