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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04585815




Registration number
NCT04585815
Ethics application status
Date submitted
30/09/2020
Date registered
14/10/2020

Titles & IDs
Public title
Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)
Scientific title
A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants With Non-Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2020-002829-28
Secondary ID [2] 0 0
B8011011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sasanlimab Prefilled syringe
Treatment: Drugs - Encorafenib
Treatment: Drugs - Binimetinib
Treatment: Drugs - Sasanlimab
Treatment: Drugs - Axitinib
Treatment: Drugs - SEA-TGT

Experimental: Sub-Study A - Sasanlimab will be administered subcutaneously. Encorafenib \& binimetinib will be administered orally. Treatments will be administered until progressive disease, unacceptable AE, participant withdraws, or study is terminated.

Experimental: Sub-Study B - Sasanlimab will be administered subcutaneously. Axitinib will be administered orally. SEA-TGT will be administered intravenously. Treatments will be administered until progressive disease, unacceptable AE, patient withdraws, or study is terminated.


Treatment: Drugs: Sasanlimab Prefilled syringe
prefilled syringe

Treatment: Drugs: Encorafenib
capsules

Treatment: Drugs: Binimetinib
tablets

Treatment: Drugs: Sasanlimab
solution supplied in vials

Treatment: Drugs: Axitinib
tablets

Treatment: Drugs: SEA-TGT
solution in vials
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT)
Timepoint [1] 0 0
Day 1 up to Day 28 of Cycle 1
Primary outcome [2] 0 0
Phase 2 of Sub-Study A: Durable Objective Response Rate (ORR)
Timepoint [2] 0 0
From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy
Primary outcome [3] 0 0
Phase 1b of Sub-Study B: Percentage of Participants With DLT
Timepoint [3] 0 0
Day 1 up to Day 21 of Cycle 1
Primary outcome [4] 0 0
Phase 2 Sub-Study B: Objective Response Rate
Timepoint [4] 0 0
From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (maximum of 21 months)
Secondary outcome [1] 0 0
Phase 1b of Sub-Study A: Number of Participants With Adverse Events (AEs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Timepoint [1] 0 0
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (approximately 44 months)
Secondary outcome [2] 0 0
Phase 2 of Sub-Study A: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0
Timepoint [2] 0 0
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment
Secondary outcome [3] 0 0
Phase 1b of Sub-Study A: Number of Participants With Laboratory Abnormalities
Timepoint [3] 0 0
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (approximately 44 months)
Secondary outcome [4] 0 0
Phase 2 of Sub-Study A: Number of Participants With Laboratory Abnormalities
Timepoint [4] 0 0
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment
Secondary outcome [5] 0 0
Phase 1b of Sub-Study A: Durable Objective Response Rate
Timepoint [5] 0 0
From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (approximately 44 months)
Secondary outcome [6] 0 0
Phase 1b of Sub-Study A: Objective Response Rate
Timepoint [6] 0 0
From the date of first dose of study treatment until the date of the first documentation of PD (approximately 44 months)
Secondary outcome [7] 0 0
Phase 2 of Sub-Study A: Objective Response Rate
Timepoint [7] 0 0
From the date of first dose of study treatment until the date of the first documentation of PD
Secondary outcome [8] 0 0
Phase 2 of Sub-Study A: Duration of Response (DR)
Timepoint [8] 0 0
From the date of first documentation of OR to the date of the first documentation of PD or death due to any cause, whichever occurred first
Secondary outcome [9] 0 0
Phase 2 of Sub-Study A: Time to Tumor Response (TTR)
Timepoint [9] 0 0
From the date of first dose of study treatment to the date of first documentation of objective response
Secondary outcome [10] 0 0
Phase 2 of Sub-Study A: Progression-Free Survival (PFS)
Timepoint [10] 0 0
From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first
Secondary outcome [11] 0 0
Phase 2 of Sub-Study A: Overall Survival (OS)
Timepoint [11] 0 0
From the date of first dose of study treatment to the date of death due to any cause or censoring date
Secondary outcome [12] 0 0
Phase 1b of Sub-Study A: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab
Timepoint [12] 0 0
Cycle 1 (pre-dose on Day 1, 168 hours [Day 8] and 336 hours [Day 15] and Day 28 post-dose) (1 cycle= 28 days)
Secondary outcome [13] 0 0
Phase 2 of Sub-Study A: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab
Timepoint [13] 0 0
Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) (1 cycle= 28 days)
Secondary outcome [14] 0 0
Phase 1b of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab
Timepoint [14] 0 0
Cycle 1 (pre-dose on Day 1, 168 hours [Day 8],336 hours [Day 15] and Day 28 post-dose) and Cycle 5 (pre-dose on Day 1 and 168 hours [Day 8] post dose) (1 cycle= 28 days)
Secondary outcome [15] 0 0
Phase 2 of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab
Timepoint [15] 0 0
Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days)
Secondary outcome [16] 0 0
Phase 1b of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab
Timepoint [16] 0 0
Cycle 1 (pre-dose on Day 1, 168 hours [Day 8], 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 (pre-dose on Day 1 and 168 hours [Day 8] post dose) (1 cycle= 28 days)
Secondary outcome [17] 0 0
Phase 2 of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab
Timepoint [17] 0 0
Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days)
Secondary outcome [18] 0 0
Phase 1b of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab
Timepoint [18] 0 0
Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days)
Secondary outcome [19] 0 0
Phase 2 of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab
Timepoint [19] 0 0
Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days)
Secondary outcome [20] 0 0
Phase 1b of Sub-Study A: Ctrough of Encorafenib
Timepoint [20] 0 0
Day 1 (pre-dose) of Cycle 1, 2 and 5; Day 15 of Cycle 1 (1 cycle= 28 days)
Secondary outcome [21] 0 0
Phase 2 of Sub-Study A: Ctrough of Encorafenib
Timepoint [21] 0 0
Cycle 5 Day 1 (pre-dose)
Secondary outcome [22] 0 0
Phase 1b of Sub-Study A: Ctrough of Binimetinib
Timepoint [22] 0 0
Day 1 (pre-dose) of Cycles 1, 2, and 5 (1 cycle= 28 days)
Secondary outcome [23] 0 0
Phase 2 of Sub-Study A: Ctrough of Binimetinib
Timepoint [23] 0 0
Cycle 5 Day 1 (pre-dose)
Secondary outcome [24] 0 0
Phase 1b of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab
Timepoint [24] 0 0
Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 255 days) (1 cycle= 28 days)
Secondary outcome [25] 0 0
Phase 2 of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab
Timepoint [25] 0 0
Pre-dose on Cycle 1 Day 1 until end of treatment
Secondary outcome [26] 0 0
Phase 2 of Sub-Study A: Objective Response (OR) Rate by Programmed Death Ligand-1 (PD-L1) Expression at Baseline
Timepoint [26] 0 0
From the date of first dose of study treatment until the date of the first documentation of PD
Secondary outcome [27] 0 0
Phase 2 of Sub-Study A: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Score
Timepoint [27] 0 0
Baseline up to end of treatment
Secondary outcome [28] 0 0
Phase 2 of Sub-Study A: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score
Timepoint [28] 0 0
Baseline up to end of treatment
Secondary outcome [29] 0 0
Phase 1b of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0
Timepoint [29] 0 0
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)
Secondary outcome [30] 0 0
Phase 2 of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0
Timepoint [30] 0 0
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)
Secondary outcome [31] 0 0
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0
Timepoint [31] 0 0
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)
Secondary outcome [32] 0 0
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0
Timepoint [32] 0 0
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)
Secondary outcome [33] 0 0
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0
Timepoint [33] 0 0
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)
Secondary outcome [34] 0 0
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0
Timepoint [34] 0 0
From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)
Secondary outcome [35] 0 0
Phase 1b of Sub-Study B: Objective Response Rate (ORR)
Timepoint [35] 0 0
From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy, whichever occurred first (maximum of 21 months)
Secondary outcome [36] 0 0
Phase 1b of Sub-Study B: Duration of Response (DR)
Timepoint [36] 0 0
From the date of first documentation of OR to the date of first documentation of PD or death, whichever occurred first (maximum of 21 months)
Secondary outcome [37] 0 0
Phase 1b of Sub-Study B: Time to Tumor Response (TTR)
Timepoint [37] 0 0
From the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) (maximum of 21 months)
Secondary outcome [38] 0 0
Phase 1b of Sub-Study B: Progression-Free Survival (PFS)
Timepoint [38] 0 0
From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first (maximum of 21 months)
Secondary outcome [39] 0 0
Phase 2 of Sub-Study B: Duration of Response (DR)
Timepoint [39] 0 0
From date of first documentation of OR to the date of first documentation of PD or death, whichever occurred first (maximum of 21 months)
Secondary outcome [40] 0 0
Phase 2 of Sub-Study B: Time to Tumor Response (TTR)
Timepoint [40] 0 0
From the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) (maximum of 21 months)
Secondary outcome [41] 0 0
Phase 2 of Sub-Study B: Progression-Free Survival (PFS)
Timepoint [41] 0 0
From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first (maximum of 21 months)
Secondary outcome [42] 0 0
Phase 2 of Sub-Study B: Overall Survival (OS)
Timepoint [42] 0 0
From the date of first dose of study treatment to the date of death due to any cause or censoring date, whichever occurred first (maximum of 21 months)
Secondary outcome [43] 0 0
Phase 1b of Sub-Study B: Cmax of Sasanlimab
Timepoint [43] 0 0
Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)
Secondary outcome [44] 0 0
Phase 1b of Sub-Study B: Cmax of Axitinib
Timepoint [44] 0 0
Cycle 1: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1; Cycle 5: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1 (1 cycle= 21 days)
Secondary outcome [45] 0 0
Phase 1b of Sub-Study B: Cmax of SEA-TGT
Timepoint [45] 0 0
Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)
Secondary outcome [46] 0 0
Phase 2 of Sub-Study B: Cmax of Sasanlimab
Timepoint [46] 0 0
Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)
Secondary outcome [47] 0 0
Phase 2 of Sub-Study B: Cmax of Axitinib
Timepoint [47] 0 0
Cycle 1: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1; Cycle 5: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1 (1 cycle= 21 days)
Secondary outcome [48] 0 0
Phase 2 of Sub-Study B: Cmax of SEA-TGT
Timepoint [48] 0 0
Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)
Secondary outcome [49] 0 0
Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab
Timepoint [49] 0 0
Pre-dose on Cycle 1 Day 1 and Cycle 5 Day 1 (1 cycle= 21 days)
Secondary outcome [50] 0 0
Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib
Timepoint [50] 0 0
Pre-dose on Cycle 1 Day 1 and Day 8; pre-dose on Cycle 5 Day 1 and Day 8 (1 cycle= 21 days)
Secondary outcome [51] 0 0
Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of SEA-TGT
Timepoint [51] 0 0
Pre-dose on Cycle 1 Day 1; pre-dose on Cycle 5 Day 1 (1 cycle= 21 days)
Secondary outcome [52] 0 0
Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab
Timepoint [52] 0 0
Cycle 1: pre-dose on Day 1, Cycle 5: pre-dose on Day 1 (1 cycle= 21 days)
Secondary outcome [53] 0 0
Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib
Timepoint [53] 0 0
Pre-dose on Cycle 1 Day 1 and Day 8; pre-dose on Cycle 5 Day 1 and Day 8 (1 cycle= 21 days)
Secondary outcome [54] 0 0
Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of SEA-TGT
Timepoint [54] 0 0
Pre-dose on Cycle 1 Day 1; pre-dose on Cycle 5 Day 1 (1 cycle= 21 days)
Secondary outcome [55] 0 0
Phase 1b of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT
Timepoint [55] 0 0
Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 21 months) (1 cycle= 21 days)
Secondary outcome [56] 0 0
Phase 2 of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT
Timepoint [56] 0 0
Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 21 months) (1 cycle= 21 days)
Secondary outcome [57] 0 0
Phase 2 of Sub-Study B: Objective Response Rate by PD-L1 Expression in Available Tumor Tissue
Timepoint [57] 0 0
From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (maximum of 21 months)

Eligibility
Key inclusion criteria
Inclusion Criteria Umbrella Phase 1b & 2:

* Histologically or cytologically confirmed locally advanced/metastatic (Stage IIIB-IV) NSCLC.
* At least one measurable lesion per RECIST v1.1 at Screening.
* ECOG Performance Status 0 or 1.
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1.
* Adequate hepatic, renal, and bone marrow function.

Additional Inclusion Criteria for Sub-Study A Phase 1b &2:

-BRAFV600E mutation in tumor tissue or plasma as determined by a local laboratory PCR or NGS assay and documented in a local pathology report.

Additional Inclusion Criteria for Sub-Study A Phase 1b only:

-Any line of therapy for locally advanced/metastatic NSCLC.

Additional Inclusion Criteria for Sub-Study A Phase 2 only:

-Previously untreated for locally advanced/metastatic NSCLC

Additional Inclusion Criteria for Sub-Study B Phase 1b only::

-Any line of therapy for locally advanced/metastatic NSCLC.

Additional Inclusion Criteria for Sub-Study B Phase 2 only:

* Previously untreated for locally advanced/metastatic NSCLC (Arms B1 & B2), or
* One or 2 prior lines of therapy for advanced/metastatic NSCLC (Arm B3), including immune checkpoint inhibitor treatment + chemotherapy, and have progressed during or after that therapy.
* PD-L1 TPS =1%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria Umbrella Phase 1b &2:

* Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
* Active non-infectious pneumonitis, pulmonary fibrosis, or known history of immune-mediated pneumonitis.
* Active infection requiring systemic therapy.
* Clinically significant cardiovascular disease.
* Other malignancy within 2 years of first dose, with exceptions.
* Symptomatic brain metastasis, with exceptions.

Additional Exclusion Criteria for Sub-Study A Phase 1b&2:

* EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement.
* Prior treatment with any BRAF inhibitor or MEK inhibitor.

Additional Exclusion Criteria for Sub-Study A Phase 2 only:

-Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.

Additional Exclusion Criteria for Sub-Study B Phase 1b&2:

-Documentation of any tumor-driving molecular alteration (eg, BRAF, EGFR, ALK)

Additional Exclusion Criteria for Sub-Study B Phase 2 only:

* Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.(Arms B1 & B2)
* Confirmed progressive disease on 1st or 2nd imaging tumor assessment after initiation of therapy for advanced/metastatic NSCLC.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
GenesisCare North Shore - St Leonards
Recruitment hospital [4] 0 0
North Shore Radiology and Nuclear Medicine - St Leonards
Recruitment hospital [5] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerpen
Country [11] 0 0
Belgium
State/province [11] 0 0
Gent
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taichung
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taipei City
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taipei
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04585815