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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

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).


Condition or disease Intervention/treatment Phase
Lung Cancer, Non-small Cell Drug: Tagrisso Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC - a Phase 2 Open-label Study
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Osimertinib

Arm Intervention/treatment
Experimental: Tagrisso 80 mg
80 mg of Tagrisso(AZD9291) will be given every day for 6 or 12 weeks.
Drug: Tagrisso
taking orally everyday for 6 or 12 weeks.
Other Name: AZD9291




Primary Outcome Measures :
  1. Overall Response Rate as defined by RECIST 1.1 [ Time Frame: 12 weeks ]
    assessed by PET-CT


Secondary Outcome Measures :
  1. mPFS measured by Kaplan-Meier method. [ Time Frame: 2 years ]
    mPFS measured by Kaplan-Meier method.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824952


Contacts
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Contact: Nir Peled, MD PhD FCCP +972 0 587040620 nirp@clalit.org.il

Locations
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Israel
Soroka University Medical Center Recruiting
Be'er Sheva, Israel, 8410101
Contact: Nir Peled, MD PhD FCCP       nirp@clalit.org.il   
Sponsors and Collaborators
Soroka University Medical Center
AstraZeneca
Investigators
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Principal Investigator: Nir Peled, MD PhD FCCP Soroka University Medical Center
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Responsible Party: Dr. Nir Peled MD, PhD, Head of Oncology, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT02824952    
Other Study ID Numbers: 0347-17-SOR
0347-17-SOR ( Other Identifier: Soroka Medical Center )
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Nir Peled MD, PhD, Soroka University Medical Center:
Tagrisso
AZD9291
EGFRm
NSCLC
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Osimertinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action