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Closed (no longer recruiting)Last updated: 30 April 2024

ARTEMIDE-01: This phase I/II study is evaluating how safe and effective a new cancer drug (AZD2936) is in people with advanced or metastatic non-small cell lung cancerPhase 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

Clinical summary

Summary

This study consists of 4 parts: Part A (dose escalation) and Parts B-D (dose expansion). AZD2936 will be given intravenously as monotherapy an in four parts.

Conditions

This trial is treating patients with non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18 - 130

Phase

I/II

Trial Acronym

ARTEMIDE-01

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

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 Antibody in Participants With Advanced or Metastatic Non-small Cell Lung Cancer

Eligibility

Inclusion

  • 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 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

Exclusion

  • 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.
  • 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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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