A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of rilvegostomig (AZD2936) Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung Cancer (ARTEMIDE-01)
- Conditions
- LungcancerNon-small cell lungcarcinoma10038666
- Registration Number
- NL-OMON54261
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
Disease for part D only:
•Stage IV squamous or non-squamous NSCLC.
•PD-L1 TPS >= 50%
•provision of archival tumor tissue (or fresh tumor tissue biopsy must
be confirmed if archival tumor tissue is not available and if clinically
feasible) is mandatory at screening for all study parts
•No sensitizing EGFR mutations or ALK fusions.
•No documented test result for other known genomic alteration for which a
targeted therapy is approved in first line per local standard of care (ROS1,
NTRK fusions, BRAF, V600E mutation, etc.)
Prior therapy:
•Part D (Dose Expansion): Must meet one of the definitions below:
(i) No prior treatment for NSCLC, and not in need of rapid disease control via
chemotherapy-containing regimen, or
(ii) Prior treatment for NSCLC with one regimen consisting of chemotherapy only.
•No unresolved toxicities of >= Grade 2 (CTCAE v5.0) from prior therapy
(excluding
vitiligo, alopecia, endocrine disorders that are controlled with replacement
hormone
therapy, asymptomatic laboratory abnormalities).
Overall condition:
•ECOG performance status 0 or 1 at enrolment.
•Life expectancy of >= 12 weeks at enrolment.
•Adequate bone marrow, liver and kidney function.
- Participants with either of the following are excluded:
(a) Sensitizing epidermal growth factor receptor mutations or anaplastic
lymphoma kinase fusions (documented test result is mandatory for patients with
non-squamous histology). For patients with squamous histology mutation, testing
is mandatory only
if participant is a never smoker or in the presence of a mixed histology.
(b) Documented test result for any other known genomic alteration for which a
targeted therapy is approved in first line per local standard of care (eg,
ROS1, NTRK fusions, BRAF, V600E mutation, etc).
- part D only:
Any prior systemic treatment with an immune-oncology agent, including but
not limited to anti-PD-1, anti-PD-L1, anti-CTLA-4. Treatment with one previous
systemic chemotherapy will be allowed.
- Symptomatic central nervous system (CNS) metastasis.
(a) Note: Participants with known CNS lesions should be asymptomatic,
adequately treated with stereotactic radiation therapy, craniotomy, gamma knife
therapy, or whole brain radiotherapy, with no subsequent evidence of CNS
progression (documented with magnetic resonance imaging [MRI] scans showing the
absence of brain metastasis progression after radiotherapeutic intervention);
participants must not require steroid exceeding 10 mg prednisone or 2 mg/day of
dexamethasone or equivalent; participants with a history of CNS metastases must
have MRI of the brain at screening. Participants with CNS metastases who are
receiving steroids must be on a stable dose of steroids for >= 7 days prior to
study entry and prior to baseline imaging.
- Thromboembolic event within 3 months before the first dose of investigational
product.
- History of organ transplant.
- Active primary immunodeficiency/active infectious disease(s):
(a) Active infection including tuberculosis (TB) (clinical evaluation that
includes clinical history, physical examination, and radiographic findings and
TB testing in line with local practice).
(b) Human immunodeficiency virus (HIV) (positive for HIV-1 or HIV-2 antibodies).
(c) Chronic or active hepatitis B, chronic or active hepatitis C; however,
participants who have chronic hepatitis B and are receiving suppressive
antiviral therapy are allowed to be enrolled if alanine aminotransferase (ALT)
is normal and viral load is controlled. Controlled hepatitis B viral load is
defined as serum hepatitis B virus DNA < 100 U/mL by polymerase chain reaction
(PCR). Participants with controlled hepatitis B viral load must remain on
antiviral therapy, per institutional practice, during the study treatment and
follow-up period to ensure adequate viral suppression. Participants who have
chronic hepatitis C are allowed to be enrolled if ALT is normal and hepatitis C
virus (HCV) RNA undetectable by PCR, either spontaneously or in response to a
successful prior course of anti-hepatitis C therapy (Regev et al,
2020).Controlled hepatitis C viral load is defined as undetectable hepatitis C
RNA by PCR
either spontaneously or in response to a successful prior course of
anti-hepatitis C therapy.
(d) Acute hepatitis A.
(e) For all participants in the study, all local institutional standards for
coronavirus disease 2019 (COVID-19) must be followed for testing. For
participants with a known previous COVID-19 infection, either
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method