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A Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (ARTEMIDE-01)

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ClinicalTrials.gov Identifier: NCT04995523
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody, AZD2936 is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Drug: AZD2936 Phase 1 Phase 2

Detailed Description:
This is a first-time-in-human (FTIH), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of AZD2936 in adult participants with stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose escalation) and Parts B-D (dose expansion).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The study includes 4 parts: Part A (dose escalation) and Parts B-D (dose expansion).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic Non-small Cell Lung Cancer
Actual Study Start Date : September 14, 2021
Estimated Primary Completion Date : December 7, 2023
Estimated Study Completion Date : December 7, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced NSCLC
AZD2936 Intravenous (IV) monotherapy
Drug: AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Experimental: Dose Expansion Part B: CPI experienced NSCLC
AZD2936 IV monotherapy
Drug: AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Experimental: Dose Expansion Part C: CPI Naive NSCLC
AZD2936 IV monotherapy
Drug: AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Experimental: Dose Expansion Part D: To be confirmed through a protocol amendment
AZD2936 IV monotherapy
Drug: AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody




Primary Outcome Measures :
  1. 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 [ Time Frame: Part A, B, C: From the time of informed consent until 90 days after the last dose of AZD2936 ]
    A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.

  2. Rate of AZD2936 discontinuation due to toxicity [ Time Frame: Part A, B, C: From first dose to the last dose of AZD2936 (an average of 6 months) ]
    Percentage of participants with AEs leading to discontinuation of AZD2936

  3. Objective Response Rate (ORR) [ Time Frame: Part B, C: From first dose of AZD2936 to progressive disease or death in the absence of disease progression (approximately 2 years) ]
    Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST v1.1


Secondary Outcome Measures :
  1. ORR [ Time Frame: Part A: From first dose of AZD2936 to progressive disease or death in the absence of disease progression (approximately 2 years) ]
    Percentage of participants with a confirmed CR or PR according to RECIST v1.1

  2. Disease control rate (DCR) [ Time Frame: Part A, B, C: From first dose of AZD2936 to progressive disease or death in the absence of disease progression (approximately 2 years) ]
    Percentage of participants who have a best objective response of confirmed CR or PR or who have SD lasting for at least a certain time of period after start of treatment

  3. Duration of response (DoR) [ Time Frame: Part A, B, C: From first dose of AZD2936 to progressive disease or death in the absence of disease progression (approximately 2 years) ]
    The time from first response according to RECIST v1.1 until progression or death in the absence of disease progression

  4. Durable response rate (DRR) [ Time Frame: Part A, B, C: From first dose of AZD2936 to progressive disease or death in the absence of disease progression (approximately 2 years) ]
    The percentage of participants according to RECIST v1.1 with a confirmed CR or PR lasting 6 months or more

  5. Progression-free survival (PFS) [ Time Frame: Part B, C: From first dose of AZD2936 to progressive disease or death in the absence of disease progression. (approximately 2 years) ]
    The time from first dose of study intervention until the date of objective disease progression or death in the absence of disease progression

  6. Measure the receptor occupancy (RO) of TIGIT and PD-1 on peripheral blood [ Time Frame: Part A, B: From first dose of study intervention, at predefined intervals throughout the administration of AZD2936 (approximately 2 years). The predefined intervals for Part A will be different from Part B and C. ]
    Evaluation of the target engagement of AZD2936 in peripheral blood

  7. PK of AZD2936: Maximum plasma concentration of the study drug (Cmax) [ Time Frame: From first dose of study intervention, at predefined intervals throughout the administration of AZD2936 (approximately 2 years). The predefined intervals for Part A will be different from Part B and C. ]
    Maximum observed plasma concentration of AZD2936

  8. PK of AZD2936: Area under the concentration-time curve (AUC) [ Time Frame: From first dose of study intervention, at predefined intervals throughout the administration of AZD2936 (approximately 2 years). The predefined intervals for Part A will be different from Part B and C. ]
    Area under the plasma concentration-time curve

  9. PK of AZD2936: Clearance [ Time Frame: From first dose of study intervention, at predefined intervals throughout the administration of AZD2936 (approximately 2 years). The predefined intervals for Part A will be different from Part B and C. ]
    A pharmacokinetic measurement of the volume of plasma from which the study intervention is completely removed per unit time.

  10. PK of AZD2936: Terminal elimination half-life (t 1/2) [ Time Frame: From first dose of study intervention, at predefined intervals throughout the administration of AZD2936 (approximately 2 years). The predefined intervals for Part A will be different from Part B and C. ]
    Terminal elimination half life

  11. Incidence of anti-drug antibodies (ADA) against AZD2936 in serum [ Time Frame: From first dose of study intervention, at predefined intervals throughout the administration of AZD2936 (approximately 2 years). The predefined intervals for Part A will be different from Part B and C. ]
    Immunogenicity of AZD2936



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Aged 18 or above
  • Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation.
  • Documented PD-L1 expression by PD-L1 IHC per local report.
  • Confirmed progression during treatment with a CPI-including regimen.
  • ECOG performance status of 0 or 1 at enrolment.
  • Life expectancy of ≥ 12 weeks at enrolment.
  • Adequate bone marrow, liver and kidney function

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.
  • Primary or secondary resistance after treatment with 2 or more regimens including a CPI.
  • Symptomatic central nervous system (CNS) metastasis.
  • Thromboembolic event within 3 months prior to enrolment.
  • Other invasive malignancy within 2 years prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04995523


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Australia
Research Site Not yet recruiting
Melbourne, Australia, 3000
Belgium
Research Site Recruiting
Bruxelles, Belgium, 1000
Research Site Not yet recruiting
Leuven, Belgium, 3000
Denmark
Research Site Recruiting
Copenhagen, Denmark, 2100
Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of, 03080
Research Site Not yet recruiting
Seoul, Korea, Republic of, 03722
Research Site Recruiting
Seoul, Korea, Republic of, 05505
Netherlands
Research Site Withdrawn
Amsterdam, Netherlands, 1066 CX
Research Site Not yet recruiting
Groningen, Netherlands, 9713 GZ
Research Site Not yet recruiting
Leiden, Netherlands, 2333 ZA
Research Site Withdrawn
Rotterdam, Netherlands, 3015 GD
Research Site Recruiting
Utrecht, Netherlands, 3584 CX
Spain
Research Site Not yet recruiting
Barcelona, Spain, 08035
Research Site Not yet recruiting
Madrid, Spain, 28027
Research Site Not yet recruiting
Madrid, Spain, 28041
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04995523    
Other Study ID Numbers: D7020C00001
2021-000857-23 ( EudraCT Number )
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
Access Criteria: 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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
TIGIT, Anti-TIGIT
PD-1, Anti-PD-1
NSCLC, Non-small Cell Lung Cancer
Advanced, Metastatic, Solid Tumor, Solid Tumour
Stage 3 NSCLC, Stage III NSCLC
Stage 4 NSCLC, Stage IV NSCLC
PD L1+ tumors
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms