NCT02824952

UnknownPhase 2

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

Shaare Zedek Medical Center Source

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Other study identifiers

Sponsor study identifier

0432-20-SZMC

Secondary identifiers

0432-20-SZMC

OTHER · Shaare Zedek Medical Center

Study Type

interventional

Estimated enrollment

40

Locations

1 country

Sites

1

Timeline

Study Start

November 1, 2018

Actual (reported)

Primary Completion

December 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 40 participants
Study completion date: December 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 29, 2016
Actual (reported)
First Posted
July 7, 2016
Actual (reported)
Study Start
November 1, 2018
Actual (reported)
Primary Completion
December 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: November 18, 2021
Status Verified: November 2021
Last Update Submitted: November 10, 2021

Conditions

Lung Cancer, Non-small Cell

Keywords

TagrissoAZD9291EGFRmNSCLC

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

TagrissoDrug

taking orally everyday for 6 or 12 weeks.

Also known as: AZD9291

Tagrisso 80 mg

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

AstraZeneca
Industrycollaborator
Shaare Zedek Medical Center
Otherlead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

Nir Peled, MD PhD FCCPCONTACTnirp@szmc.org.il

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory 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

Actual (reported)

Primary Completion

December 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

NCT02841579

Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M

Phase 2Completed

NCT02811354

Phase II Study of AZD9291 in Advanced Stage NSCLC With EGFR and T790M Mutations Detected in Plasma Ct-DNA

Phase 2Unknown

NCT04581824

Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

Phase 2Terminated

NCT04706949

Pyrotinib Combined With Pemetrexed Plus Carboplatin in the First-line Treatment

Phase 2Unknown

NCT02771314

Liquid Biopsy as a Tool to Evaluate Resistance to First and Third (AZD9291) (EGFR) (TKIs) in (EGFR) Mutant NSCLC

Phase 2Unknown

NCT03804580

First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer

Phase 2Unknown

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;
+2 more criteria

Contact the study team to confirm eligibility.

Study Completion

December 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

November 18, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02824952
Data provider: ClinicalTrials.gov
Source updated: 2021-11-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:16 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Tagrisso 80 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations