Last updated 33 days ago
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
210 patients around the world
Available in United States, Brazil, Spain
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 rilvegostomig (AZD2936) in adult participants with
stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose
escalation) and Parts B-E (dose expansion).
AstraZeneca
210Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
To 130 Years
All Gender
Medical requirements
- Written informed consentAged 18 or abovePart 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
- Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusionDocumented 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 therapyAny 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.
StudyARTEMIDE-01
SponsorAstraZeneca
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
To 130 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04995523
