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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04995523




Registration number
NCT04995523
Ethics application status
Date submitted
16/07/2021
Date registered
9/08/2021

Titles & IDs
Public title
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
Scientific title
Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
Secondary ID [1] 0 0
2023-508262-15-00
Secondary ID [2] 0 0
D7020C00001
Universal Trial Number (UTN)
Trial acronym
ARTEMIDE-01
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD2936

Experimental: Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC) - Rilvegostomig Intravenous (IV) monotherapy

Experimental: Dose Expansion Part B: CPI experienced NSCLC - Rilvegostomig IV monotherapy

Experimental: Dose Expansion Part C: CPI Naive NSCLC - Rilvegostomig IV monotherapy

Experimental: Dose Expansion Part D: CPI Naive NSCLC - Rilvegostomig IV monotherapy

Experimental: Dose Expansion Part E: treatment Naive Squamous NSCLC - Rilvegostomig IV monotherapy


Treatment: Drugs: AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with adverse events (AEs) and immune mediated AEs (imAEs), serious AEs (SAEs), dose limiting toxicities (DLTs), vital signs, and abnormal laboratory parameters
Timepoint [1] 0 0
Part A, B, C, D and E: From the time of informed consent until 90 days after the last dose of rilvegostomig
Primary outcome [2] 0 0
Rate of rilvegostomig discontinuation due to toxicity
Timepoint [2] 0 0
Part A, B, C, D and E: From first dose to the last dose of rilvegostomig (an average of 6 months)
Primary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Part B, C, D and E: From first dose of rilvegostomig to progressive disease (PD) or death in the absence of disease progression (approximately 2 years)
Secondary outcome [1] 0 0
ORR
Timepoint [1] 0 0
Part A: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Secondary outcome [2] 0 0
Disease control rate (DCR)
Timepoint [2] 0 0
Part A, B, C, E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).
Secondary outcome [3] 0 0
Duration of response (DoR)
Timepoint [3] 0 0
Part A, B, C, D and E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Secondary outcome [4] 0 0
Durable response rate (DRR)
Timepoint [4] 0 0
Part A, B, C, D and E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Secondary outcome [5] 0 0
Progression-free survival (PFS)
Timepoint [5] 0 0
Part B, C, E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).
Secondary outcome [6] 0 0
Measure the receptor occupancy (RO) of TIGIT and PD-1 on peripheral blood
Timepoint [6] 0 0
Part A, B: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B.
Secondary outcome [7] 0 0
PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)
Timepoint [7] 0 0
From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Secondary outcome [8] 0 0
PK of rilvegostomig: Area under the concentration-time curve (AUC)
Timepoint [8] 0 0
From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Secondary outcome [9] 0 0
PK of rilvegostomig: Clearance
Timepoint [9] 0 0
From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Secondary outcome [10] 0 0
PK of rilvegostomig: Terminal elimination half-life (t 1/2)
Timepoint [10] 0 0
From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Secondary outcome [11] 0 0
Incidence of anti-drug antibodies (ADA) against rilvegostomig in serum
Timepoint [11] 0 0
From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.

Eligibility
Key inclusion criteria
* Written informed consent
* Aged 18 or above
* Part A and Part B: Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part C and Part D: Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part E: Stage IV squamous NSCLC not amenable to curative surgery or radiation.
* Documented PD-L1 expression by PD-L1 IHC per local report.
* Part A and Part B: Confirmed progression during treatment with a CPI-including regimen.
* Part C and Part D: No prior I/O treatment for metastatic NSCLC.
* Part E: No prior treatment for metastatic NSCLC.
* ECOG performance status of 0 or 1 at enrolment.
* Life expectancy of = 12 weeks at enrolment.
* Have at least 1 measurable lesion per RECIST v1.1.
* Adequate bone marrow, liver and kidney function
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion
* Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation)
* Previous treatment with an anti-TIGIT therapy
* Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
* Part A and Part B: Primary or secondary resistance after treatment with 2 or more regiments including a CPI.
* Part C and Part D: Any prior systemic treatment with an immune oncology agent (prior administration of immune-oncology agent for curative intent to treat other invasive malignancy is permitted).

Treatment with one previous systemic chemotherapy will be allowed.

* Part E: Any prior systemic treatment for metastatic NSCLC, including but not limited to chemotherapy, anti-PD-1, anti-PD-L1, anti-CTLA-4.
* Symptomatic central nervous system (CNS) metastasis.
* Thromboembolic event within 3 months prior to enrolment.
* Other invasive malignancy within 2 years prior to screening.

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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/03/2028
Actual
Sample size
Target
199
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
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
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Belgium
State/province [7] 0 0
Anderlecht
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Brazil
State/province [9] 0 0
Florianópolis
Country [10] 0 0
Brazil
State/province [10] 0 0
Natal
Country [11] 0 0
Brazil
State/province [11] 0 0
Porto Alegre
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio de Janeiro
Country [13] 0 0
Brazil
State/province [13] 0 0
Sao Paulo
Country [14] 0 0
China
State/province [14] 0 0
Chengdu
Country [15] 0 0
China
State/province [15] 0 0
Chongqing
Country [16] 0 0
China
State/province [16] 0 0
Wuhan
Country [17] 0 0
Denmark
State/province [17] 0 0
Copenhagen
Country [18] 0 0
France
State/province [18] 0 0
Dijon
Country [19] 0 0
France
State/province [19] 0 0
Toulouse
Country [20] 0 0
Georgia
State/province [20] 0 0
Tbilisi
Country [21] 0 0
Japan
State/province [21] 0 0
Kashiwa
Country [22] 0 0
Japan
State/province [22] 0 0
Niigata-shi
Country [23] 0 0
Japan
State/province [23] 0 0
Sendai-shi
Country [24] 0 0
Japan
State/province [24] 0 0
Tokyo
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seoul
Country [26] 0 0
Malaysia
State/province [26] 0 0
Kuala Lumpur
Country [27] 0 0
Malaysia
State/province [27] 0 0
Kuching
Country [28] 0 0
Moldova, Republic of
State/province [28] 0 0
Chisinau
Country [29] 0 0
Netherlands
State/province [29] 0 0
Groningen
Country [30] 0 0
Netherlands
State/province [30] 0 0
Leiden
Country [31] 0 0
Netherlands
State/province [31] 0 0
Utrecht
Country [32] 0 0
Singapore
State/province [32] 0 0
Singapore
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taichung
Country [36] 0 0
Taiwan
State/province [36] 0 0
Tainan City
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei City
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taipei
Country [39] 0 0
Thailand
State/province [39] 0 0
Bangkok
Country [40] 0 0
Thailand
State/province [40] 0 0
Muang
Country [41] 0 0
Thailand
State/province [41] 0 0
Mueang Chanthaburi
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Leicester
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Manchester

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
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
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.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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 rerefer 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 datain 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://astrazenecagroup-dt.pharmacm.com/DT/Home


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/NCT04995523