Lung Cancer, Non-small CellPhase 2NCT02824952
Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC
A Phase 2 study testing Tagrisso in people with Lung Cancer, Non-small Cell, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell
- What is being tested?
- Tagrisso
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2018to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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;
- 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.
- Any evidence/past medical history of interstitial lung disease (ILD) or radiation pneumonitis which required steroid treatment.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem
Nir Peled, MD PhD FCCP, nirp@szmc.org.il
About this study
Official title: Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC - a Phase 2 Open-label Study
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).
Read the 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.
- Conditions
- Lung Cancer, Non-small Cell
- Being tested
- Tagrisso
- Keywords
- Tagrisso, AZD9291, EGFRm, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TagrissoDrug
Also called AZD9291
taking orally everyday for 6 or 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tagrisso 80 mg | Experimental | 80 mg of Tagrisso(AZD9291) will be given every day for 6 or 12 weeks. Receives: Drug: Tagrisso |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate as defined by RECIST 1.1
assessed by PET-CT
Measured: 12 weeks
Secondary outcomes (2)
mPFS measured by Kaplan-Meier method.
mPFS measured by Kaplan-Meier method.
Measured: 2 years
Comparing GTV (Gross tumor volume) before and after the neoadjuvant therapy
Comparing GTV (Gross tumor volume) before and after the neoadjuvant therapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start1 Nov 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-small CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Nir Peled, Shaare Zedek Medical Center
- Investigators
- Nir Peled, MD PhD FCCP, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824952
- Sponsor's protocol ID
- 0432-20-SZMC
- Other IDs
- 0432-20-SZMC
- Status last verified
- Nov 2021
- First submitted
- 29 Jun 2016
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC - a Phase 2 Open-label Study
- ClinicalTrials.gov ID
- NCT02824952
- Acronym / sponsor ID
- 0432-20-SZMC
- Conditions
- Lung Cancer, Non-small Cell
- Keywords
- Tagrisso, AZD9291, EGFRm, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tagrisso 80 mg | Experimental | Drug: Tagrisso80 mg of Tagrisso(AZD9291) will be given every day for 6 or 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- Measurable disease by RECIST criteria v1.1.
- Patients are amenable for curative chemo-radiotherapy.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TagrissoAlso: AZD9291taking orally everyday for 6 or 12 weeks. | Drug | Tagrisso 80 mg |
Primary outcome
Overall Response Rate as defined by RECIST 1.1
Time frame: 12 weeks
assessed by PET-CT
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nir Peled, MD PhD FCCP principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tagrisso in people with Lung Cancer, Non-small Cell, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nir Peled, MD PhD FCCP (+972 0 587040620, nirp@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate as defined by RECIST 1.1 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.