Back to resultsPhase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung04)
Primary Purpose
Advanced or Metastatic NSCLC
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Datopotamab deruxtecan
Durvalumab
Carboplatin
AZD2936
MEDI5752
Sponsored by
About this trial
This is an interventional treatment trial for Advanced or Metastatic NSCLC focused on measuring Advanced or Metastatic NSCLC, Datopotamab deruxtecan (Dato-DXd), DS-1062a, Durvalumab, AZD2936, MEDI5752
Eligibility Criteria
Inclusion Criteria:
- Participant ≥18 years old on the day of signing the ICF (local regulatory requirement to consent should be followed).
- Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC, without EGFR or ALK genomic alterations and no known genomic alterations in other actionable driver kinases with approved therapies
- For Cohorts 1 to 4, participants must be treatment-naïve or have received and radiologically progressed after only 1 prior line of systemic chemotherapy, without concomitant immune checkpoint inhibitors for advanced or metastatic NSCLC. For Cohorts 5 to 11, participants must be treatment-naïve for advanced or metastatic NSCLC.
- Willing and able to undergo a mandatory tumor biopsy
- Has measurable disease per RECIST1.1 within 28 days prior to Cycle 1 Day 1
- Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 at screening
- Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 day 1
- For Cohorts 5 to 11 only: Documented IHC PD-L1 expression per analytically validated Ventana PD-L1 (SP263) IHC assay, 22C3 PharmDx assay, or 28-8 PharmDx assay
Exclusion Criteria:
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled or significant cardiac disease
- History of another primary malignancy
- active or uncontrolled hepatitis B or C virus or uncontrolled HIV infection
- spinal cord compression or clinically active CNS metastases
- History of (non-infectious) ILD/pneumonitis that required steroids
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illness
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Clinically significant corneal disease
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Cohort 6
Cohort 7
Cohort 8
Cohort 9
Cohort 10
Cohort 11
Arm Description
Datopotamab deruxtecan (Dato-DXd) + Durvalumab
Datopotamab deruxtecan (Dato-DXd) + Durvalumab
Datopotamab deruxtecan (Dato-DXd) + Durvalumab + Carboplatin
Datopotamab deruxtecan (Dato-DXd) + Durvalumab + Carboplatin
Datopotamab deruxtecan (Dato-DXd) + AZD2936
Datopotamab deruxtecan (Dato-DXd) + AZD2936
Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin
Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin
Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin
Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin
Datopotamab deruxtecan (Dato-DXd) + MEDI5752
Outcomes
Primary Outcome Measures
Number of participants with DLTs; TEAEs and other safety parameters during the study.
DLTs, TEAEs, SAEs, AESIs, ECOG PS, vital sign measurements, standard clinical laboratory parameters (hematology, clinical chemistry, and urinalysis), ECG parameters, ECHO/MUGA scan findings, and ophthalmologic findings
Secondary Outcome Measures
ORR as assessed by investigator per RECIST Version 1.1
ORR is defined as the proportion of participants with measurable disease at baseline who achieved a BOR of confirmed CR or confirmed PR.
Duration of Response as assessed by investigator per RECIST version 1.1
Duration of Response is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first documentation of objective PD, or death due to any cause, whichever occurs first.
Disease Control Rate as assessed by the investigator per RECIST version 1.1
Disease Control Rate is defined as the proportion of participants who achieved a Best Overall Response of confirmed complete response, confirmed partial response, or stable disease.
Progression-free Survival as assessed by the investigator per RECIST v1.1
Progression-free Survival is defined as the time interval from the date of the start of study treatment to the earlier of the dates of the first documentation of objective PD or death due to any cause, whichever occurs first
Time to Response as assessed by investigator per RECIST Version 1.1
Time to Response is defined as the time from the date of the start of study treatment to the date of the first documentation of objective response (confirmed complete response or confirmed partial response)
Best percentage change in the Sum of Diameters of measurable tumors
The best percentage change in the Sum of Diameters of measurable tumors is defined as the percentage change in the smallest Sum of Diameters from all postbaseline tumor assessments, taking as reference the baseline Sum of Diameters.
Overall Survival
Overall Survival is defined as the time from the date of the start of study treatment to the date of death due to any cause
Pharmacokinetic Parameter Maximum Plasma/Serum Concentration (Cmax) of Dato-DXd, Total anti-TROP2 antibody, and MAAA-1181a and AZD2936. Serum concentrations of durvalumab and MEDI5752.
Cmax = Maximum concentration
Pharmacokinetic Parameter Time to Maximum Plasma/Serum Concentration (Tmax) of Dato-DXd, Total anti-TROP2 antibody, and MAAA-1181a and AZD2936. Serum concentrations of durvalumab and MEDI5752.
Tmax = time to reach maximum concentration.
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) of Dato-DXd, AZD2936, Total anti-TROP2 antibody, and MAAA-1181a (Dose Escalation and Dose Expansion)
Area under the plasma concentration-time curve up to last quantifiable time (AUClast) and area under the plasma concentration-time curve during dosing interval (AUCtau) will be assessed.
Prevalence of Dato-Dxd, durvalumab, AZD2936 and MEDI5752
ADA prevalence is defined as the proportion of all participants having ADA at any point in time (including pre-existing ADA at baseline and treatment-emergent ADA)
Incidence of Dato-DXd, durvalumab, AZD2936 and MEDI5752 ADA
ADA incidence is defined as the proportion of participants having treatment-emergent ADA during the study period
Full Information
NCT ID
NCT04612751
First Posted
October 21, 2020
Last Updated
August 16, 2023
Sponsor
AstraZeneca
Collaborators
Daiichi Sankyo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04612751
Brief Title
Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer
Acronym
TROPION-Lung04
Official Title
A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Immunotherapy With or Without Carboplatin in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
January 30, 2026 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Daiichi Sankyo, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Detailed Description
The primary objective is to assess the safety and tolerability of Dato-DXd in combination with immunotherapy with or without 4 cycles of carboplatin in participants with advanced or metastatic NSCLC who are either treatment-naïve or have received 1 prior line of systemic chemotherapy without concurrent ICI
Two dose levels of Dato-DXd will be studied in combination with fixed-dose of durvalumab, AZD2936, or MEDI5752, with or without 4 cycles of carboplatin in 11 study cohorts
Each cohort will start with Part 1 (dose escalation or confirmation), where 3 to 9 participants will be assessed for dose-limiting toxicities (DLT) in the first cycle of treatment. if the DLT incidence rate meets the criteria based on the modified toxicity probability interval-2 (mTPI-2), then Part 2 (dose expansion) may be opened.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Metastatic NSCLC
Keywords
Advanced or Metastatic NSCLC, Datopotamab deruxtecan (Dato-DXd), DS-1062a, Durvalumab, AZD2936, MEDI5752
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Dose escalation and dose expansion model
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
232 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Datopotamab deruxtecan (Dato-DXd) + Durvalumab
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Datopotamab deruxtecan (Dato-DXd) + Durvalumab
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Datopotamab deruxtecan (Dato-DXd) + Durvalumab + Carboplatin
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Datopotamab deruxtecan (Dato-DXd) + Durvalumab + Carboplatin
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Datopotamab deruxtecan (Dato-DXd) + AZD2936
Arm Title
Cohort 6
Arm Type
Experimental
Arm Description
Datopotamab deruxtecan (Dato-DXd) + AZD2936
Arm Title
Cohort 7
Arm Type
Experimental
Arm Description
Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin
Arm Title
Cohort 8
Arm Type
Experimental
Arm Description
Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin
Arm Title
Cohort 9
Arm Type
Experimental
Arm Description
Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin
Arm Title
Cohort 10
Arm Type
Experimental
Arm Description
Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin
Arm Title
Cohort 11
Arm Type
Experimental
Arm Description
Datopotamab deruxtecan (Dato-DXd) + MEDI5752
Intervention Type
Drug
Intervention Name(s)
Datopotamab deruxtecan
Other Intervention Name(s)
Dato-DXd
Intervention Description
Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
Imfinzi
Intervention Description
Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
AZD2936
Intervention Description
Intravenous infusion prior to Dato-DXd
Intervention Type
Drug
Intervention Name(s)
MEDI5752
Intervention Description
Intravenous infusion prior to Dato-DXd
Primary Outcome Measure Information:
Title
Number of participants with DLTs; TEAEs and other safety parameters during the study.
Description
DLTs, TEAEs, SAEs, AESIs, ECOG PS, vital sign measurements, standard clinical laboratory parameters (hematology, clinical chemistry, and urinalysis), ECG parameters, ECHO/MUGA scan findings, and ophthalmologic findings
Time Frame
DLTs: within first cycle (21 days); TEAEs and other safety parameters: when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up (approximately 55 months)
Secondary Outcome Measure Information:
Title
ORR as assessed by investigator per RECIST Version 1.1
Description
ORR is defined as the proportion of participants with measurable disease at baseline who achieved a BOR of confirmed CR or confirmed PR.
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
Title
Duration of Response as assessed by investigator per RECIST version 1.1
Description
Duration of Response is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first documentation of objective PD, or death due to any cause, whichever occurs first.
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
Title
Disease Control Rate as assessed by the investigator per RECIST version 1.1
Description
Disease Control Rate is defined as the proportion of participants who achieved a Best Overall Response of confirmed complete response, confirmed partial response, or stable disease.
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
Title
Progression-free Survival as assessed by the investigator per RECIST v1.1
Description
Progression-free Survival is defined as the time interval from the date of the start of study treatment to the earlier of the dates of the first documentation of objective PD or death due to any cause, whichever occurs first
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
Title
Time to Response as assessed by investigator per RECIST Version 1.1
Description
Time to Response is defined as the time from the date of the start of study treatment to the date of the first documentation of objective response (confirmed complete response or confirmed partial response)
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
Title
Best percentage change in the Sum of Diameters of measurable tumors
Description
The best percentage change in the Sum of Diameters of measurable tumors is defined as the percentage change in the smallest Sum of Diameters from all postbaseline tumor assessments, taking as reference the baseline Sum of Diameters.
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
Title
Overall Survival
Description
Overall Survival is defined as the time from the date of the start of study treatment to the date of death due to any cause
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
Title
Pharmacokinetic Parameter Maximum Plasma/Serum Concentration (Cmax) of Dato-DXd, Total anti-TROP2 antibody, and MAAA-1181a and AZD2936. Serum concentrations of durvalumab and MEDI5752.
Description
Cmax = Maximum concentration
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
Title
Pharmacokinetic Parameter Time to Maximum Plasma/Serum Concentration (Tmax) of Dato-DXd, Total anti-TROP2 antibody, and MAAA-1181a and AZD2936. Serum concentrations of durvalumab and MEDI5752.
Description
Tmax = time to reach maximum concentration.
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
Title
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) of Dato-DXd, AZD2936, Total anti-TROP2 antibody, and MAAA-1181a (Dose Escalation and Dose Expansion)
Description
Area under the plasma concentration-time curve up to last quantifiable time (AUClast) and area under the plasma concentration-time curve during dosing interval (AUCtau) will be assessed.
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
Title
Prevalence of Dato-Dxd, durvalumab, AZD2936 and MEDI5752
Description
ADA prevalence is defined as the proportion of all participants having ADA at any point in time (including pre-existing ADA at baseline and treatment-emergent ADA)
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
Title
Incidence of Dato-DXd, durvalumab, AZD2936 and MEDI5752 ADA
Description
ADA incidence is defined as the proportion of participants having treatment-emergent ADA during the study period
Time Frame
At the time of the final analysis (when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 9 months of follow-up, approximately 55 months).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant ≥18 years old on the day of signing the ICF (local regulatory requirement to consent should be followed).
Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC, without EGFR or ALK genomic alterations and no known genomic alterations in other actionable driver kinases with approved therapies
For Cohorts 1 to 4, participants must be treatment-naïve or have received and radiologically progressed after only 1 prior line of systemic chemotherapy, without concomitant immune checkpoint inhibitors for advanced or metastatic NSCLC. For Cohorts 5 to 11, participants must be treatment-naïve for advanced or metastatic NSCLC.
Willing and able to undergo a mandatory tumor biopsy
Has measurable disease per RECIST1.1 within 28 days prior to Cycle 1 Day 1
Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 at screening
Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 day 1
For Cohorts 5 to 11 only: Documented IHC PD-L1 expression per analytically validated Ventana PD-L1 (SP263) IHC assay, 22C3 PharmDx assay, or 28-8 PharmDx assay
Exclusion Criteria:
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled or significant cardiac disease
History of another primary malignancy
active or uncontrolled hepatitis B or C virus or uncontrolled HIV infection
spinal cord compression or clinically active CNS metastases
History of (non-infectious) ILD/pneumonitis that required steroids
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illness
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
Clinically significant corneal disease
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
Facility Information:
Facility Name
Research Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Completed
Facility Name
Research Site
City
Tyrone
State/Province
Georgia
ZIP/Postal Code
30290
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Withdrawn
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
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Withdrawn
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
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Completed
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paris Cedex 05
ZIP/Postal Code
75248
Country
France
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
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
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cheongiu
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hwasun-gun
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
JinJoo
ZIP/Postal Code
52727
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
138736
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Poland
ZIP/Postal Code
20-950
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
A Coruña
ZIP/Postal Code
15005
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41015
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Suspended
Facility Name
Research Site
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Suspended
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
00333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Withdrawn
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 requests 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
Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer
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