Register a trial

This website allows the public to search and find relevant clinical trials. It is also for approved external groups to reconnect to the ANZCTR’s API.


Registration, updating trial details and changing user account details are not yet available.


If you are concerned about obtaining a prospective registration label for your trial on time, we recommend registering your trial on ClinicalTrials.gov or your closest WHO-recognised Primary Registry (see https://www.who.int/clinical-trials-registry-platform/network/primary-registries).


We apologise for this disruption. As soon as we know when registering and updating trials will become available, this information will be listed on this website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04745689




Registration number
NCT04745689
Ethics application status
Date submitted
16/12/2020
Date registered
9/02/2021

Titles & IDs
Public title
Study of AZD2811 + Durvalumab in ES-SCLC
Scientific title
A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction With Platinum-Based Chemotherapy Combined With Durvalumab, for the First-Line Treatment of Patients With Extensive Stage Small-Cell Lung Cancer
Secondary ID [1] 0 0
D6132C00001
Universal Trial Number (UTN)
Trial acronym
TAZMAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small-Cell Lung Cancer 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 - Durvalumab
Treatment: Drugs - AZD2811
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Etoposide

Experimental: AZD2811 + Durvalumab - Induction:

Durvalumab + Platinum Chemotherapy (Carboplatin or cisplatin \& Etoposide)

Maintenance:

AZD2811 + Durvalumab


Treatment: Drugs: Durvalumab
IV infusions through induction phase.

IV infusions through maintenance phase until PD or other discontinuation criteria.

Treatment: Drugs: AZD2811
IV infusions through maintenance phase until PD or other discontinuation criteria.

Treatment: Drugs: Carboplatin
IV infusions through induction phase if chosen by Investigator.

Treatment: Drugs: Cisplatin
IV infusions through induction phase if chosen by Investigator.

Treatment: Drugs: Etoposide
IV infusions through induction phase.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maintenance participants alive and progression free (APF12) per RECIST 1.1 [Efficacy]
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [1] 0 0
Maintenance participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18)
Timepoint [1] 0 0
Up to 18 months
Secondary outcome [2] 0 0
Maintenance participants alive and progression free at 6 months (APF6) and 9 months (APF9) using investigator assessments according to RECIST 1.1
Timepoint [2] 0 0
Up to 9 months
Secondary outcome [3] 0 0
Objective response rate (ORR) for all participants using investigator assessments according to RECIST 1.1
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1
Timepoint [4] 0 0
Approximately 3 years
Secondary outcome [5] 0 0
Overall survival (OS) in maintenance participants
Timepoint [5] 0 0
Approximately 3 years
Secondary outcome [6] 0 0
Assess safety and tolerability profile in terms safety assessments, adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event [CTCAE] v5.0, and dose modifications
Timepoint [6] 0 0
Approximately 3 years
Secondary outcome [7] 0 0
Cmin of durvalumab
Timepoint [7] 0 0
Predose Maintenance Day 1 of Cycles 5 and 7 (up to approximately 3 years)
Secondary outcome [8] 0 0
Cmax of durvalumab
Timepoint [8] 0 0
Predose Maintenance Day 1 of Cycles 5 and 7 (up to approximately 3 years)
Secondary outcome [9] 0 0
AZD2811 PK: Pharmacokinetics of AZD2811 and its metabolites by measuring whole blood concentration
Timepoint [9] 0 0
Approximately 3 years
Secondary outcome [10] 0 0
EORTC 30: Health related quality of life based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire - Cancer (QLQ-C30) v3.0.
Timepoint [10] 0 0
Approximately 3 years
Secondary outcome [11] 0 0
EORTC 13: Lung cancer specific quality of life based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire - Lung Cancer (QLQ-LC13) v1.0.
Timepoint [11] 0 0
Approximately 3 years

Eligibility
Key inclusion criteria
* Documented evidence of extensive stage SCLC (ES-SCLC)
* Participants must be considered suitable to receive an induction platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC
* No prior exposure to immune-mediated therapy
* Life expectancy =12 weeks at Day 1.
* ECOG 0 or 1 at enrolment.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy
* Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS
* Active infection including tuberculosis, HIV, hepatitis B and C
* Active or prior documented autoimmune or inflammatory disorders
* Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.

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
Single group
Other design features
Phase
Phase 2
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
23/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Cheongju-si
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Jinju-si
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul
Country [5] 0 0
Poland
State/province [5] 0 0
Bydgoszcz
Country [6] 0 0
Poland
State/province [6] 0 0
Olsztyn
Country [7] 0 0
Poland
State/province [7] 0 0
Poznan
Country [8] 0 0
Spain
State/province [8] 0 0
Sevilla
Country [9] 0 0
Spain
State/province [9] 0 0
Valencia

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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 refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04745689