search
Back to results

Durvalumab vs Placebo With Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients / Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation (PACIFIC-4)

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Placebo
Osimertinib (single-arm, open-label)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring NSCLC, Early-Stage NSCLC, Lung cancer, Double- Blind, PD-L1, MEDI4736, Durvalumab, Osimertinib, PFS, OS, Unresected lung cancer, Inoperable, Operable, SBRT, SABR, EGFR

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Cohort Key Inclusion Criteria:

  1. Age ≥18 years
  2. Planned SoC SBRT as definitive treatment
  3. WHO/ECOG PS of 0, 1 or 2
  4. Life expectancy of at least 12 weeks
  5. Body weight >30 kg
  6. Submission of tumor tissue sample if available
  7. Adequate organ and marrow function required
  8. Patients with central or peripheral lesions are eligible
  9. Staging studies must be done during screening (PET-CT within 10 weeks)
  10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions

Main Cohort Key Exclusion Criteria:

  1. Mixed small cell and non-small cell cancer
  2. History of allogeneic organ transplantation
  3. History of another primary malignancy with exceptions
  4. History of active primary immunodeficiency
  5. Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
  6. Prior exposure to immune-mediated therapy with exceptions

Osimertinib Cohort Key Inclusion Criteria

  1. Age ≥18 years
  2. Planned SoC SBRT as definitive treatment
  3. World Health Organization (WHO)/ECOG PS of 0, 1, or 2
  4. Patients with central or peripheral lesions are eligible
  5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
  6. Staging studies must be done during screening (PET-CT within 10 weeks)
  7. Submission of available tumor tissue sample
  8. Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
  9. Adequate bone marrow reserve or organ function required
  10. Female patients should be using highly effective contraceptive measures
  11. Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation

Osimertinib Cohort Key Exclusion Criteria

  1. Mixed small cell and non-small cell cancer
  2. Patients currently receiving potent inducers of CYP3A4
  3. Patients with known or increased risk factor for QTc prolongation
  4. Treatment with any of the following:

    • Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
    • Prior treatment with neoadjuvant or adjuvant EGFR TKI
    • Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4
    • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
  5. Any of the following cardiac criteria

    • Mean resting corrected QT interval >470 msec, obtained from 3 ECGs
    • 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, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval
    • Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

Sites / Locations

  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research Site
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting
  • Research SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

SoC SBRT + Durvalumab Therapy (Main Cohort)

SoC SBRT + Placebo Therapy (Main Cohort)

SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, separate cohort)

Arm Description

SBRT - delivered in 3, 4, 5 or 8 fractions. Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.

SBRT - delivered in 3, 4, 5 or 8 fractions. Placebo (matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.

SBRT delivered in 3, 4, 5 or 8 fractions Osimertinib 80mg every day [qd] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC
Main Cohort
4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria
Osimertinib Cohort

Secondary Outcome Measures

Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC
Main Cohort
Overall Survival (OS)
Main Cohort
Lung cancer-specific mortality
Main Cohort
Maximum Plasma concentration (Cmax)
Main Cohort
Detection of ADA neutralising antibodies titers
Main Cohort
Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30
Main Cohort
Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1
Main Cohort
Time to progression (TTP) assessed by BICR according to RECIST 1.1
Main Cohort
Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1
Main Cohort
Time from randomisation to second progression (PFS2) as defined by local standard clinical practice
Main Cohort
Trough Concentration (Ctrough)
Main Cohort
Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of Durvalumab with SoC SBRT compared to placebo with SoC SBRT
Main Cohort
Assessment of AEs by CTCAE v 5.0 as measures of the safety, tolerability and compliance of osimertinib with SoC SBRT therapy
Osimertinib Cohort
WHO performance status
Osimertinib Cohort
ECG QT interval
Osimertinib Cohort
Overall Survival
Osimertinib Cohort
Lung cancer mortality
Osimertinib Cohort
Time To Progression (TTP)
Osimertinib Cohort
Time to CNS progression
Osimertinib Cohort
PFS2
Osimertinib Cohort
Site(s) of disease progression
Osimertinib Cohort
PFS by ICR using RECIST 1.1
Osimertinib Cohort

Full Information

First Posted
January 25, 2019
Last Updated
July 14, 2023
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT03833154
Brief Title
Durvalumab vs Placebo With Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients / Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation
Acronym
PACIFIC-4
Official Title
A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
April 4, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC. An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.
Detailed Description
Patients who are to receive SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to Durvalumab or placebo. The primary objective of main cohort is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of Overall Survival (OS). In addition, a study cohort with a sufficient number of patients harboring an EGFR mutation, will receive Osimertinib treatment after completion of SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC. The primary objective of Osimertinib cohort is to assess efficacy of Osimertinib following SoC SBRT in terms of 4years-PFS. Key secondary objectives include safety, OS and efficacy of Osimertininb treatment with SBRT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
NSCLC, Early-Stage NSCLC, Lung cancer, Double- Blind, PD-L1, MEDI4736, Durvalumab, Osimertinib, PFS, OS, Unresected lung cancer, Inoperable, Operable, SBRT, SABR, EGFR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double- Blind
Allocation
Randomized
Enrollment
690 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SoC SBRT + Durvalumab Therapy (Main Cohort)
Arm Type
Experimental
Arm Description
SBRT - delivered in 3, 4, 5 or 8 fractions. Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.
Arm Title
SoC SBRT + Placebo Therapy (Main Cohort)
Arm Type
Placebo Comparator
Arm Description
SBRT - delivered in 3, 4, 5 or 8 fractions. Placebo (matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.
Arm Title
SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, separate cohort)
Arm Type
Experimental
Arm Description
SBRT delivered in 3, 4, 5 or 8 fractions Osimertinib 80mg every day [qd] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.
Intervention Type
Drug
Intervention Name(s)
Osimertinib (single-arm, open-label)
Intervention Description
Osimertinib 80 mg every day [qd] orally for up to 36 months or until progression or other discontinuation criteria are met. Osimertinib treatment should start from 7 to 14 days after completion of SBRT
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC
Description
Main Cohort
Time Frame
from randomization up to 6 years
Title
4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria
Description
Osimertinib Cohort
Time Frame
from randomization up to 5 years
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC
Description
Main Cohort
Time Frame
from randomization up to 6 years
Title
Overall Survival (OS)
Description
Main Cohort
Time Frame
from randomization up to 7 years
Title
Lung cancer-specific mortality
Description
Main Cohort
Time Frame
from randomization up to 7 years
Title
Maximum Plasma concentration (Cmax)
Description
Main Cohort
Time Frame
12 weeks after last dose
Title
Detection of ADA neutralising antibodies titers
Description
Main Cohort
Time Frame
up to 6 months after last dose
Title
Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30
Description
Main Cohort
Time Frame
from randomization up to 7 years
Title
Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1
Description
Main Cohort
Time Frame
at 24 months following randomization
Title
Time to progression (TTP) assessed by BICR according to RECIST 1.1
Description
Main Cohort
Time Frame
from randomization up to 6 years
Title
Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1
Description
Main Cohort
Time Frame
from randomization up to 6 years
Title
Time from randomisation to second progression (PFS2) as defined by local standard clinical practice
Description
Main Cohort
Time Frame
from randomization up to 7 years
Title
Trough Concentration (Ctrough)
Description
Main Cohort
Time Frame
up to 3 months after last dose
Title
Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of Durvalumab with SoC SBRT compared to placebo with SoC SBRT
Description
Main Cohort
Time Frame
up to 3 months after last dose
Title
Assessment of AEs by CTCAE v 5.0 as measures of the safety, tolerability and compliance of osimertinib with SoC SBRT therapy
Description
Osimertinib Cohort
Time Frame
Up to 35 days after last dose
Title
WHO performance status
Description
Osimertinib Cohort
Time Frame
from randomization Up to 5 years
Title
ECG QT interval
Description
Osimertinib Cohort
Time Frame
Up to 156 weeks of treatment or treatment discontinuation
Title
Overall Survival
Description
Osimertinib Cohort
Time Frame
from randomization Up to 5 years
Title
Lung cancer mortality
Description
Osimertinib Cohort
Time Frame
from randomization Up to 5 years
Title
Time To Progression (TTP)
Description
Osimertinib Cohort
Time Frame
from randomization Up to 5 years
Title
Time to CNS progression
Description
Osimertinib Cohort
Time Frame
from randomization Up to 5 years
Title
PFS2
Description
Osimertinib Cohort
Time Frame
from randomization up to 5 years
Title
Site(s) of disease progression
Description
Osimertinib Cohort
Time Frame
from randomization up to 5 years
Title
PFS by ICR using RECIST 1.1
Description
Osimertinib Cohort
Time Frame
from randomization up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Cohort Key Inclusion Criteria: Age ≥18 years Planned SoC SBRT as definitive treatment WHO/ECOG PS of 0, 1 or 2 Life expectancy of at least 12 weeks Body weight >30 kg Submission of tumor tissue sample if available Adequate organ and marrow function required Patients with central or peripheral lesions are eligible Staging studies must be done during screening (PET-CT within 10 weeks) Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions Main Cohort Key Exclusion Criteria: Mixed small cell and non-small cell cancer History of allogeneic organ transplantation History of another primary malignancy with exceptions History of active primary immunodeficiency Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort Prior exposure to immune-mediated therapy with exceptions Osimertinib Cohort Key Inclusion Criteria Age ≥18 years Planned SoC SBRT as definitive treatment World Health Organization (WHO)/ECOG PS of 0, 1, or 2 Patients with central or peripheral lesions are eligible Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions Staging studies must be done during screening (PET-CT within 10 weeks) Submission of available tumor tissue sample Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R) Adequate bone marrow reserve or organ function required Female patients should be using highly effective contraceptive measures Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation Osimertinib Cohort Key Exclusion Criteria Mixed small cell and non-small cell cancer Patients currently receiving potent inducers of CYP3A4 Patients with known or increased risk factor for QTc prolongation Treatment with any of the following: Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation Prior treatment with neoadjuvant or adjuvant EGFR TKI Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib Any of the following cardiac criteria Mean resting corrected QT interval >470 msec, obtained from 3 ECGs 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, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
First Name & Middle Initial & Last Name or Official Title & Degree
Astrazeneca Cancer Study Locator Service
Phone
1-877-400-4656
Email
AstraZeneca@emergingmed.com
Facility Information:
Facility Name
Research Site
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35401
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Arroyo Grande
State/Province
California
ZIP/Postal Code
93420
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
10709
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60126
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Suspended
Facility Name
Research Site
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Berlin
State/Province
Maryland
ZIP/Postal Code
21811
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Rosedale
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Suspended
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Suspended
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Completed
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sherman
State/Province
Texas
ZIP/Postal Code
75090
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Individual Site Status
Completed
Facility Name
Research Site
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53212
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Suspended
Facility Name
Research Site
City
Blacktown
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Elizabeth Vale
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Recife
ZIP/Postal Code
52010-075
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
22271-110
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01327-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Volta Redonda
ZIP/Postal Code
27253-003
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Terminated
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610042
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310002
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
2501117
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200002
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
100003
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suzhou
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nantes
ZIP/Postal Code
44202
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13359
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Duisburg
ZIP/Postal Code
47228
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40489
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30459
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
München
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Trier
ZIP/Postal Code
54292
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11526
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
18547
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
55236
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kfar Saba
ZIP/Postal Code
95847
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Akashi-shi
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hirosaki-shi
ZIP/Postal Code
036-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kobe-shi
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Niigata-shi
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sakai-shi
ZIP/Postal Code
591-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toyoake-shi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
362-804
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Research Site
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-044
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Elbląg
ZIP/Postal Code
02-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-514
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hato Rey
ZIP/Postal Code
00917
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620905
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Kazan, Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119421
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Badajoz
ZIP/Postal Code
6006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Terminated
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Sebastián
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kocaeli
ZIP/Postal Code
41400
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

Durvalumab vs Placebo With Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients / Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation

We'll reach out to this number within 24 hrs