Trial Review

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/ct2/show/NCT04745689




Registration number
NCT04745689
Ethics application status
Date submitted
16/12/2020
Date registered
9/02/2021
Date last updated
15/12/2022

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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04745689
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04745689