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Clinical Trials/JPRN-jRCT2031220297
JPRN-jRCT2031220297
Recruiting
Phase 1

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. - ARTEMIDE-01

Hibi Kazushige0 sites18 target enrollmentAugust 27, 2022
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Conditionson-Small-Cell Lung Carcinoma

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
on-Small-Cell Lung Carcinoma
Sponsor
Hibi Kazushige
Enrollment
18
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 27, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hibi Kazushige

Eligibility Criteria

Inclusion Criteria

  • •Written informed consent
  • •\- Aged 18 or above
  • •\- Part A: 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 : 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 or more 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 : 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.
  • •\- Symptomatic central nervous system (CNS) metastasis.
  • •\- Thromboembolic event within 3 months prior to enrolment.
  • •\- Other invasive malignancy within 2 years prior to screening.

Outcomes

Primary Outcomes

Not specified

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