A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung Cancer

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 (ARTEMIDE-01) - ARTEMIDE-01

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000857-23-NL

Enrollment

192

Registered

2021-07-23

Start date

2021-09-03

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer, stage III unresectable Non-small Cell Lung Cancer, stage IV Non-small Cell Lung Cancer. MedDRA version: 20.1 Level: LLT Classification code 10080083 Term: Advanced lung cancer System Organ Class: 100000004864

Interventions

Product Name: AZD2936 Product Code: AZD2936 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: rilvegostomig CAS Number: 2640305-01-5 Current Sponsor code: AZD2

Eligibility

Sex/Gender

All

Inclusion 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. - Confirmed progression during treatment with a CPI-including regimen (Part A, Part B). - No prior IO treatment for NSCLC (Part C, Part D). - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 96

Exclusion criteria

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 regimens 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). - Symptomatic central nervous system (CNS) metastasis. - Thromboembolic event within 3 months prior to enrolment. - Other invasive malignancy within 2 years prior to screening.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the safety, PK, pharmacodynamics, and efficacy of rilvegostomig in adult participants with stage III unresectable or stage IV NSCLC.;Secondary Objective: To assess the immunogenicity of rilvegostomig and to assess the PK profile compatibility of rilvegostomig in 2L+ CPI experienced and 1L CPI naïve participants with stage III/IV unresectable NSCLC.;Primary end point(s): Part A: - Safety and tolerability of rilvegostomig, assessed by the percentage of patients with adverse events, immune-mediated adverse events and dose-limiting toxicities as well as the rate of discontinuation of rilvegostomig due to toxicity. Part B and Part C: - Safety and tolerability of rilvegostomig at the recommended Phase II dose, assessed by the percentage of patients with adverse events, immune-mediated adverse events and dose-limiting toxicity-like events as well as the rate of discontinuation of rilvegostomig due to toxicity. - Preliminary anti-tumour activity of rilvegostomig, assessed by objective response rate (ORR) according to RECIST 1.1 Part D: -Safety and tolerability of rilvegostomig at the recommended Phase II dose and a higher dose, assessed by the percentage of patients with adverse events, immune-mediated adverse events and dose-limiting toxicity-like events as well as the rate of discontinuation of rilvegostomig due to toxicity. - Preliminary anti-tumour activity of rilvegostomig, assessed by objective response rate (ORR) according to RECIST 1.1 All parts of study: Vital signs and abnormal laboratory parameters;Timepoint(s) of evaluation of this end point: Safety: from time of informed consent until 90 days after the last dose of study intervention. Efficacy: from first dose of study intervention to progressive disease or death (in absence of disease progression).	—

Measure

Time frame

Main Objective: Evaluate the safety, PK, pharmacodynamics, and efficacy of rilvegostomig in adult participants with stage III unresectable or stage IV NSCLC.;Secondary Objective: To assess the immunogenicity of rilvegostomig and to assess the PK profile compatibility of rilvegostomig in 2L+ CPI experienced and 1L CPI naïve participants with stage III/IV unresectable NSCLC.;Primary end point(s): Part A: - Safety and tolerability of rilvegostomig, assessed by the percentage of patients with adverse events, immune-mediated adverse events and dose-limiting toxicities as well as the rate of discontinuation of rilvegostomig due to toxicity. Part B and Part C: - Safety and tolerability of rilvegostomig at the recommended Phase II dose, assessed by the percentage of patients with adverse events, immune-mediated adverse events and dose-limiting toxicity-like events as well as the rate of discontinuation of rilvegostomig due to toxicity. - Preliminary anti-tumour activity of rilvegostomig, assessed by objective response rate (ORR) according to RECIST 1.1 Part D: -Safety and tolerability of rilvegostomig at the recommended Phase II dose and a higher dose, assessed by the percentage of patients with adverse events, immune-mediated adverse events and dose-limiting toxicity-like events as well as the rate of discontinuation of rilvegostomig due to toxicity. - Preliminary anti-tumour activity of rilvegostomig, assessed by objective response rate (ORR) according to RECIST 1.1 All parts of study: Vital signs and abnormal laboratory parameters;Timepoint(s) of evaluation of this end point: Safety: from time of informed consent until 90 days after the last dose of study intervention. Efficacy: from first dose of study intervention to progressive disease or death (in absence of disease progression).

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Secondary

Measure	Time frame
Secondary end point(s): Part A: - Preliminary anti-tumour activity of rilvegostomig, assessed by objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and durable response rate (DRR) according to RECIST 1.1 - Target engagement of rilvegostomig in peripheral blood, assessed by TIGIT and PD-1 receptor occupancy (RO) on peripheral blood T cells Part B: - Preliminary anti-tumour activity of rilvegostomig at the recommended Phase II dose, assessed by disease control rate (DCR), duration of response (DoR), durable response rate (DRR) and progression-free survival (PFS) according to RECIST 1.1 - Target engagement of rilvegostomig in peripheral blood, assessed by TIGIT and PD-1 receptor occupancy (RO) on peripheral blood T cells Part C: - Preliminary anti-tumour activity of rilvegostomig at the recommended Phase II dose, assessed by disease control rate (DCR), duration of response (DoR), durable response rate (DRR) and progression-free survival (PFS) according to RECIST 1.1 Part D: - Preliminary anti-tumour activity of rilvegostomig at the recommended Phase II dose and a higher dose, assessed by disease control rate (DCR), duration of response (DoR), durable response rate (DRR) and progression-free survival (PFS) according to RECIST 1.1 All parts of study: - PK profile compatibility of rilvegostomig with the study dosing schedule in patients with stage III/IV unresectable NSCLC, assessed by serum concentrations, PK parameters (Cmax, AUC, clearance, etc.) - Immunogenicity of rilvegostomig, assessed by the incidence of ADAs against rilvegostomig in serum;Timepoint(s) of evaluation of this end point: Safety: from time of informed consent until 90 days after the last dose of study intervention. Efficacy: For Part A, B and C, from first dose of study intervention to progressive disease or death (in absence of disease progression) ; For Part D, from randomization to progressive disease or death (in absence of disease progression)	—

Measure

Time frame

Secondary end point(s): Part A: - Preliminary anti-tumour activity of rilvegostomig, assessed by objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and durable response rate (DRR) according to RECIST 1.1 - Target engagement of rilvegostomig in peripheral blood, assessed by TIGIT and PD-1 receptor occupancy (RO) on peripheral blood T cells Part B: - Preliminary anti-tumour activity of rilvegostomig at the recommended Phase II dose, assessed by disease control rate (DCR), duration of response (DoR), durable response rate (DRR) and progression-free survival (PFS) according to RECIST 1.1 - Target engagement of rilvegostomig in peripheral blood, assessed by TIGIT and PD-1 receptor occupancy (RO) on peripheral blood T cells Part C: - Preliminary anti-tumour activity of rilvegostomig at the recommended Phase II dose, assessed by disease control rate (DCR), duration of response (DoR), durable response rate (DRR) and progression-free survival (PFS) according to RECIST 1.1 Part D: - Preliminary anti-tumour activity of rilvegostomig at the recommended Phase II dose and a higher dose, assessed by disease control rate (DCR), duration of response (DoR), durable response rate (DRR) and progression-free survival (PFS) according to RECIST 1.1 All parts of study: - PK profile compatibility of rilvegostomig with the study dosing schedule in patients with stage III/IV unresectable NSCLC, assessed by serum concentrations, PK parameters (Cmax, AUC, clearance, etc.) - Immunogenicity of rilvegostomig, assessed by the incidence of ADAs against rilvegostomig in serum;Timepoint(s) of evaluation of this end point: Safety: from time of informed consent until 90 days after the last dose of study intervention. Efficacy: For Part A, B and C, from first dose of study intervention to progressive disease or death (in absence of disease progression) ; For Part D, from randomization to progressive disease or death (in absence of disease progression)

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Countries

Australia, Belgium, Brazil, China, Denmark, France, Japan, Korea, Republic of, Malaysia, Netherlands, Singapore, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactClinical Study Information Center

AstraZeneca

Information.Center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026