Summary
EudraCT Number:2021-000857-23
Sponsor's Protocol Code Number:D7020C00001
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2021-10-08
Trial results
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2021-000857-23
A.3Full title of the trial
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)
Estudio en fase I/II abierto, de escalada y expansión de dosis para evaluar la seguridad, farmacocinética, farmacodinámica y eficacia del anticuerpo biespecífico anti-TIGIT/anti-PD-1 AZD2936 en pacientes con cáncer de pulmón no microcítico avanzado o metastásico.
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung Cancer
Un estudio del anticuerpo biespecífico anti-TIGIT/anti-PD-1 AZD2936 en pacientes con cáncer de pulmón no microcítico avanzado o metastásico.
A.3.2Name or abbreviated title of the trial where available
ARTEMIDE-01
ARTEMIDE-01
A.4.1Sponsor's protocol code numberD7020C00001
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorAstraZeneca AB
B.1.3.4CountrySweden
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportAstraZeneca AB
B.4.2CountrySweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
B.5.2Functional name of contact pointUnidad de Investigación Clínica
B.5.3 Address:
B.5.3.1Street AddressSerrano Galvache, 56; Parque Norte, Edificio Álamo
B.5.3.2Town/ cityMadrid
B.5.3.3Post code28033
B.5.3.4CountrySpain
B.5.4Telephone number0034900200444
B.5.6E-mail[email protected]
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameAZD2936
D.3.2Product code AZD2936
D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNAZD2936
D.3.9.2Current sponsor codeAZD2936
D.3.9.3Other descriptive nameMonovalent bispecific humanized IgG1 antibody
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number50
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
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.
Cáncer de pulmón de células no pequeñas avanzado, Cáncer de pulmón de células no pequeñas metastásico, Cáncer de pulmón de células no pequeñas irresecable en estadio III, Cáncer de pulmón de células no pequeñas en estadio IV.
E.1.1.1Medical condition in easily understood language
Non-small Cell Lung Cancer, which is either localized but too big to be removed by surgery or has already spread throughout the body.
Cáncer de pulmón de células no pequeñas, que está localizado pero es demasiado grande para ser extraído quirúrgicamente o que ya se ha extendido por todo el cuerpo.
E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.1
E.1.2Level LLT
E.1.2Classification code 10080083
E.1.2Term Advanced lung cancer
E.1.2System Organ Class 100000004864
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Evaluate the safety, PK, pharmacodynamics, and efficacy of AZD2936 in adult participants with stage III unresectable or stage IV NSCLC.
Evaluar la seguridad, farmacocinética, farmacodinamia y eficacia de AZD2936 en participantes adultos con CPCNP en estadio III irresecable o estadio IV.
E.2.2Secondary objectives of the trial
To assess the immunogenicity of AZD2936 and to assess the PK profile compatibility of AZD2936 in 2L+ CPI experienced and 1L CPI naïve participants with stage III/IV unresectable NSCLC.
Evaluar la inmunogenicidad de AZD2936 y la compatibilidad del perfil farmacocinético de AZD2936 en pacientes con experiencia en 2L + CPI y 1L CPI sin tratamiento previo con CPCNP irresecable en estadio III/IV.
E.2.3Trial contains a sub-study No
E.3Principal 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 (Part A, Part B).
- No prior treatment (including IO agents) for NSCLC (Part C only).
- ECOG performance status of 0 or 1 at enrolment.
- Life expectancy of ≥ 12 weeks at enrolment.
- Adequate bone marrow, liver and kidney function.
- Consentimiento informado firmado.
- 18 años de edad, o mayor.
- CPCNP irresecable en estadio III o escamoso o no escamoso en estadio IV
no susceptible a cirugía curativa o radiación.
- Expresión de PD-L1 documentada por PD-L1 IHC según informe local.
- Progresión confirmada durante el tratamiento con un régimen que incluye CPI (Parte A, Parte B).
- No hubo tratamiento previo (incluidos los agentes IO) para el CPCNP (solo la Parte C).
- Estado funcional ECOG de 0 o 1 en el momento del reclutamiento.
- Esperanza de vida ≥ 12 semanas en el momento del reclutamiento.
- Función adecuada de la médula ósea, el hígado y los riñones.
E.4Principal 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.
- Sensibilización de mutaciones en el receptor del factor de crecimiento epidérmico (EGFR) o fusión de la quinasa del linfoma anaplásico (ALK).
- Resultado de prueba documentada para cualquier otra alteración genómica conocida para la cual hay terapia dirigida aprobada en primera línea según el estándar local de cuidados (por ejemplo, ROS1, fusiones NTRK, BRAF, mutación V600E)
- Tratamiento previo con terapia anti-TIGIT.
- Cualquier quimioterapia, radioterapia; terapia con fármaco en investigación, biológica u hormonal para el tratamiento contra el cáncer.
- Resistencia primaria o secundaria después del tratamiento con 2 o más regímenes que incluyen un IPC.
- Metástasis sintomática del sistema nervioso central (SNC).
- Evento tromboembólico en los 3 meses anteriores al reclutamiento.
- Otra neoplasia maligna invasiva en los 2 años anteriores al screening.
E.5 End points
E.5.1Primary end point(s)
Part A:
- Safety and tolerability of AZD2936, 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 AZD2936 due to toxicity.

Part B:
- Safety and tolerability of AZD2936, 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 AZD2936 due to toxicity.
- Preliminary anti-tumour activity of AZD2936, assessed by objective response rate (ORR) according to RECIST 1.1
Parte A:
- Seguridad y tolerabilidad de AZD2936, evaluada por el porcentaje de
pacientes con eventos adversos, eventos adversos inmunomediados y
toxicidades limitantes de la dosis, así como la tasa de interrupción de AZD2936 debido a la toxicidad.

Parte B:
- Seguridad y tolerabilidad de AZD2936, evaluada por el porcentaje de
pacientes con eventos adversos, eventos adversos inmunomediados y
toxicidades limitantes de la dosis, así como la tasa de interrupción de AZD2936 debido a la toxicidad.
- Actividad antitumoral preliminar de AZD2936, evaluada por objetivo
tasa de respuesta (ORR) según RECIST 1.1
E.5.1.1Timepoint(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).
Seguridad: desde la firma del consentimiento informado hasta 90 días después de la última dosis de intervención del estudio.
Eficacia: desde la primera dosis de la intervención del estudio hasta la progresión de la enfermedad o muerte (si no hay progresión de la enfermedad).
E.5.2Secondary end point(s)
Part A:
- Preliminary anti-tumour activity of AZD2936, 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 AZD2936 in peripheral blood, assessed by TIGIT and PD-1 receptor occupancy (RO) on peripheral blood T cells and NK cells.

Part B:
- Preliminary anti-tumour activity of AZD2936, 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 AZD2936 in peripheral blood, assessed by TIGIT and PD-1 receptor occupancy (RO) on peripheral blood T cells and NK cells.
Parte A:
- Actividad antitumoral preliminar de AZD2936, evaluada por tasa de respuesta objetiva (ORR), tasa de control de enfermedad (DCR), duración de respuesta (DoR) y tasa de respuesta duradera (DRR) según RECIST 1.1.
- Compromiso de objetivo de AZD2936 en sangre periférica, evaluado por TIGIT y ocupación del receptor PD-1 (RO) en células T de sangre periférica y células NK.

Parte B:
- Actividad antitumoral preliminar de AZD2936, evaluada por tasa de control de enfermedad (DCR), duración de la respuesta (DoR), tasa de respuesta duradera (RRD) y supervivencia libre de progresión (SLP) según RECIST 1.1.
- Compromiso de objetivo de AZD2936 en sangre periférica, evaluado por TIGIT y ocupación del receptor PD-1 (RO) en células T de sangre periférica y células NK.
E.5.2.1Timepoint(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).
Seguridad: desde el momento de la firma en consentimiento informado hasta 90 días después de la última dosis de intervención del estudio.
Eficacia: desde la primera dosis de la intervención del estudio hasta la progresión de la enfermedad o muerte (si no hay progresión de la enfermedad).
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response Yes
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Yes
E.7.1.1First administration to humans Yes
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised No
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned3
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA23
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
Australia
Belgium
China
Denmark
France
Germany
Italy
Japan
Korea, Republic of
Netherlands
Poland
Spain
United Kingdom
United States
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the SoA for the last participant in the study globally.
El final del estudio se define como la fecha de la última visita del último
paciente en el estudio o el último procedimiento programado que se muestra en el SoA para el último paciente en el estudio a nivel mundial.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months9
E.8.9.1In the Member State concerned days28
E.8.9.2In all countries concerned by the trial years2
E.8.9.2In all countries concerned by the trial months2
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 40
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 107
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state20
F.4.2 For a multinational trial
F.4.2.1In the EEA 38
F.4.2.2In the whole clinical trial 147
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
None
Ninguno
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2021-12-28
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2021-12-02
P. End of Trial
P.End of Trial StatusOngoing