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Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC

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ClinicalTrials.gov Identifier: NCT02824952
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr. Nir Peled MD, PhD, Soroka University Medical Center

Tracking Information
First Submitted Date  ICMJE June 29, 2016
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2016)
Overall Response Rate as defined by RECIST 1.1 [ Time Frame: 12 weeks ]
assessed by PET-CT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2020)
  • mPFS measured by Kaplan-Meier method. [ Time Frame: 2 years ]
    mPFS measured by Kaplan-Meier method.
  • Comparing GTV (Gross tumor volume) before and after the neoadjuvant therapy [ Time Frame: 2 years ]
    Comparing GTV (Gross tumor volume) before and after the neoadjuvant therapy
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2016)
  • mPFS measured by Kaplan-Meier method. [ Time Frame: 2 years ]
  • Comparing GTV (Gross tumor volume) before and after the neoadjuvant therapy [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC
Official Title  ICMJE Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC - a Phase 2 Open-label Study
Brief Summary

Patients will receive AZD9291 at a dose of 80 mg once daily. Systemic evaluation will be done by PET-CT scan after 6 weeks.

In responding patients AZD9291 will be given orally 80 mg daily for 12 weeks. Non-responding patients will receive AZD9291 for the period of 6 or 12 weeks (according to the results of response assessment at each time-point).

Detailed Description

Patients will receive AZD9291 at a dose of 80 mg once daily. Systemic evaluation will be done by PET-CT scan after 6 weeks.

In responding patients AZD9291 will be given orally 80 mg daily for 12 weeks. Non-responding patients will receive AZD9291 for the period of 6 or 12 weeks (according to the results of response assessment at each time-point). All the patients will be followed for 2 years.

The imaging modality used for RECIST v1.1 assessments will be PET-CT scan.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer, Non-small Cell
Intervention  ICMJE Drug: Tagrisso
taking orally everyday for 6 or 12 weeks.
Other Name: AZD9291
Study Arms  ICMJE Experimental: Tagrisso 80 mg
80 mg of Tagrisso(AZD9291) will be given every day for 6 or 12 weeks.
Intervention: Drug: Tagrisso
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria.

  1. Provision of informed consent prior to any study specific procedures
  2. Male or female, aged at least 18 years.
  3. Treatment-naïve stage IIIA/B NSCLC with an activating sensitizing EGFR mutation/T790M

    • Uncommon sensitizing EGFR mutations are allowed.

  4. Measurable disease by RECIST criteria v1.1.
  5. Patients are amenable for curative chemo-radiotherapy.
  6. ECOG PS 0/1.

    •total bilirubin less then 1.5 mg/dL, ALT+ AST levels 3 times above the upper normal limit.

  7. Normal hematologic, renal and liver function:

    • Absolute neutrophil count over 1500/mm3, platelets over 100,000/mm3, hemoglobin over 9 g/dL;
    • Creatinine concentration less than 1 mg/dL, or creatinine clearance over 60 mL/min;
    • Total bilirubin less than 1.5 mg/dL, ALT and AST levels 3 times above the upper normal limit.
  8. FEV-1 more than1 liter.
  9. Female patients with reproductive potential must have a negative pregnancy test (serum/urine) prior to starting treatment.
  10. All patients with reproductive potential must agree to use barrier contraception methods while receiving the study treatment.

Exclusion criteria

  1. EGFR TKI - resistant EGFR mutations (e.g., insertion in exon 20)
  2. T790M is allowed.
  3. Treatment with any of the following:
  4. Prior treatment with any systemic anti-cancer therapy for advanced NSCLC;
  5. Prior treatment with an EGFR-TKI;
  6. Major surgery within 4 weeks of the first dose of study drug;
  7. Treatment with an investigational drug within five half-lives of the compound.
  8. Pregnant or lactating women.
  9. Inability to sign the informed consent form.
  10. Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug.
  11. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV), uncontrolled diabetes.
  12. Inability to swallow the formulated product, malabsorption syndrome, refractory nausea and vomiting that would preclude adequate absorption of AZD9291.
  13. Any of the following cardiac criteria:
  14. Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 consequent ECGs, using the screening clinic ECG machine-derived QTc value;
  15. Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG;
  16. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, including unexplained sudden death under 40 years of age in a first-degree relative, or any concomitant medication known to prolong the QTc interval.
  17. Any evidence/past medical history of interstitial lung disease (ILD) or radiation pneumonitis which required steroid treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nir Peled, MD PhD FCCP +972 0 587040620 nirp@clalit.org.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02824952
Other Study ID Numbers  ICMJE 0347-17-SOR
0347-17-SOR ( Other Identifier: Soroka Medical Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Nir Peled MD, PhD, Soroka University Medical Center
Study Sponsor  ICMJE Soroka University Medical Center
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Nir Peled, MD PhD FCCP Soroka University Medical Center
PRS Account Soroka University Medical Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP