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

NCT02824952 | Unknown Phase 2

• 1 other identifier: 0432-20-SZMC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Lung Cancer, Non-small Cell

Keywords

Tagrisso; AZD9291; EGFRm; NSCLC

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate as defined by RECIST 1.1

  assessed by PET-CT

  12 weeks

Secondary Outcomes (2)

• mPFS measured by Kaplan-Meier method.

  2 years

• Comparing GTV (Gross tumor volume) before and after the neoadjuvant therapy

  2 years

Study Arms (1)

Tagrisso 80 mg

EXPERIMENTAL

80 mg of Tagrisso(AZD9291) will be given every day for 6 or 12 weeks.

Drug: Tagrisso

Interventions

Tagrisso DRUG

taking orally everyday for 6 or 12 weeks.

Also known as: AZD9291

Tagrisso 80 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Male or female, aged at least 18 years.
• Treatment-naïve stage IIIA/B NSCLC with an activating sensitizing EGFR mutation/T790M
• Uncommon sensitizing EGFR mutations are allowed.
• Measurable disease by RECIST criteria v1.1.
• Patients are amenable for curative chemo-radiotherapy.
• ECOG PS 0/1.
• total bilirubin less then 1.5 mg/dL, ALT+ AST levels 3 times above the upper normal limit.
• 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.
• FEV-1 more than1 liter.
• Female patients with reproductive potential must have a negative pregnancy test (serum/urine) prior to starting treatment.
• All patients with reproductive potential must agree to use barrier contraception methods while receiving the study treatment.

You may not qualify if:

• EGFR TKI - resistant EGFR mutations (e.g., insertion in exon 20)
• T790M is allowed.
• Treatment with any of the following:
• Prior treatment with any systemic anti-cancer therapy for advanced NSCLC;
• Prior treatment with an EGFR-TKI;
• Major surgery within 4 weeks of the first dose of study drug;
• Treatment with an investigational drug within five half-lives of the compound.
• Pregnant or lactating women.
• Inability to sign the informed consent form.
• Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug.
• 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.
• Inability to swallow the formulated product, malabsorption syndrome, refractory nausea and vomiting that would preclude adequate absorption of AZD9291.
• Any of the following cardiac criteria:
• Mean resting corrected QT interval (QTc) \>470 msec, obtained from 3 consequent ECGs, using the screening clinic ECG machine-derived QTc value;
• Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG;

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nir Peled, MD PhD FCCP

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nir Peled, MD PhD FCCP

CONTACT

+972 0 587040620; nirp@szmc.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oncology

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 7, 2016
• Study Start: November 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)