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Trial record 1 of 4 for:    AZD2936
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Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (ARTEMIDE-01)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04995523
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : May 30, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The study includes 4 parts: Part A: Dose escalation; B & C: Dose expansion non-randomized; D: Randomized RP2D & alternative dose.
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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 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 : July 14, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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
Other Name: Rilvegostomig
Experimental: Dose Expansion Part B: CPI experienced NSCLC
AZD2936 IV monotherapy
 Drug: AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Other Name: Rilvegostomig
Experimental: Dose Expansion Part C: CPI Naive NSCLC
AZD2936 IV monotherapy
 Drug: AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Other Name: Rilvegostomig
Experimental: Dose Expansion Part D: CPI Naive NSCLC
AZD2936 IV monotherapy
 Drug: AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Other Name: Rilvegostomig


Outcome Measures
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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 and D: 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 and D: 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 and D: From first dose of AZD2936 to progressive disease (PD) 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 PD 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 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). ]
    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 and D: From first dose of AZD2936 to PD 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 and D: From first dose of AZD2936 to PD 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 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). ]
    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. ]
    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, C and D. ]
    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, C and D. ]
    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, C and D. ]
    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, C and D. ]
    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, C and D. ]
    Immunogenicity of AZD2936


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
  • 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.
  • 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 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

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 (Treatment with one previous systemic chemotherapy will be allowed).
  • 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.
Contacts and Locations
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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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United States, California
Research Site Withdrawn
Orange, California, United States, 92868
United States, Illinois
Research Site Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
Research Site Withdrawn
Baltimore, Maryland, United States, 21201
United States, Minnesota
Research Site Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Texas
Research Site Withdrawn
Houston, Texas, United States, 77030
United States, Virginia
Research Site Recruiting
Fairfax, Virginia, United States, 22031
Australia
Research Site Recruiting
Melbourne, Australia, 3000
Belgium
Research Site Recruiting
Anderlecht, Belgium, 1070
Research Site Recruiting
Leuven, Belgium, 3000
Brazil
Research Site Recruiting
Florianópolis, Brazil, 88034-000
Research Site Recruiting
Porto Alegre, Brazil, 90035903
Research Site Not yet recruiting
Rio de Janeiro, Brazil, 20231-050
Research Site Recruiting
Sao Paulo, Brazil, 01246-000
China
Research Site Recruiting
Chengdu, China, 610041
Denmark
Research Site Active, not recruiting
Copenhagen, Denmark, 2100
France
Research Site Not yet recruiting
Dijon, France, 21079
Research Site Recruiting
Toulouse Cedex 09, France, 31059
Japan
Research Site Recruiting
Kashiwa, Japan, 227-8577
Research Site Not yet recruiting
Niigata-shi, Japan, 951-8566
Research Site Not yet recruiting
Sendai-shi, Japan, 980-0873
Research Site Recruiting
Tokyo, Japan, 104-0045
Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of, 03082
Research Site Recruiting
Seoul, Korea, Republic of, 03722
Research Site Recruiting
Seoul, Korea, Republic of, 05505
Malaysia
Research Site Not yet recruiting
Kuala Lumpur, Malaysia, 59100
Research Site Not yet recruiting
Kuching, Malaysia, 93586
Netherlands
Research Site Recruiting
Groningen, Netherlands, 9713 GZ
Research Site Recruiting
Leiden, Netherlands, 2333 ZA
Research Site Recruiting
Utrecht, Netherlands, 3584 CX
Singapore
Research Site Not yet recruiting
Singapore, Singapore, 308433
Spain
Research Site Recruiting
Barcelona, Spain, 08035
Research Site Recruiting
Madrid, Spain, 28027
Research Site Recruiting
Madrid, Spain, 28041
Taiwan
Research Site Recruiting
Taichung, Taiwan, 40201
Research Site Recruiting
Taichung, Taiwan
Research Site Not yet recruiting
Tainan City, Taiwan, 70403
Research Site Not yet recruiting
Taipei City, Taiwan, 110
Research Site Withdrawn
Taipei, Taiwan, 10002
Thailand
Research Site Not yet recruiting
Bangkok, Thailand, 10700
Research Site Not yet recruiting
Muang, Thailand, 50200
Research Site Not yet recruiting
Mueang Chanthaburi, Thailand, 22000
United Kingdom
Research Site Withdrawn
Leicester, United Kingdom, LE1 5WW
Research Site Withdrawn
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
AstraZeneca
More Information
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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: May 30, 2023
Last Verified: May 2023
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: Yes
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