A Phase 3, Randomized, Open-Label Study to Compare Ociperlimab (BGBA1217) Plus Tislelizumab (BGB-A317) Versus Durvalumab in Patients With Locally Advanced, Unresectable, PD L1 Selected Non- Small Cell Lung Cancer Whose Disease Has Not Progressed After Concurrent Chemoradiotherapy

Phase 3

Withdrawn

• Conditions: Non-Small Cell Lung Cancer (NSCLC); 10038666

• Registration Number: NL-OMON52181
• Lead Sponsor: BeiGene, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

Each patient eligible to participate in this study must meet all the following
criteria:
• Histologically or cytologically confirmed, unresectable locally advanced
Stage III NSCLC
(AJCC Cancer Staging Manual 2017, derived from International Association for
the Study of
Lung Cancer [IASLC]) prior to cCRT.
• Have completed >= 2 cycles of platinum-based chemotherapy concurrent with
radiotherapy.
For patients who are recovering from toxicities associated with the prior
treatment, the first
dose of study drug(s) may be delayed by up to 42 days from the end of the cCRT.
It is
recommended to screen the patients within 14 days after the completion of cCRT.
• Have not experienced PD following definitive, platinum-based cCRT.
CONFIDENTIAL
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• Agree to provide archival tissue (formalin-fixed paraffin-embedded block
containing tumor
[preferred] or approximately 6 to 15 freshly cut unstained slides) or fresh
biopsy (if archival
tissue is not available) for prospective central evaluation of PD-L1 levels and
retrospective
analysis of other biomarkers. PD-L1 status will be assessed centrally in either
a previously
obtained archival tumor tissue or fresh tissue obtained from a biopsy collected
prior to the
first dose of cCRT via VENTANA PD-L1 (SP263) assay. Only patients with PD-L1
expression on >= 1% of TC are eligible.

Exclusion Criteria

Patients who meet any of the following criteria are NOT eligible to enroll:
• Prior therapy with an anti-programmed cell death-1(PD-1), anti-PD-L1,
anti-PD-L2,
anti-T-cell immunoglobulin and ITIM domain (TIGIT), or any other antibody or
drugs
specifically targeting T-cell co-stimulation or checkpoint pathways.
• Diagnosed with NSCLC that harbors an epidermal growth factor receptor
(EGFR)sensitizing
mutation, anaplastic lymphoma kinase (ALK) gene translocation, ROS1 gene
translocation, or RET
gene rearrangement.
• Distant metastasis identified by imaging assessment and/or other examinations
after
definitive, platinum-based cCRT.
• Have received chemotherapy and radiotherapy with <= 1 cycle overlap for LA
NSCLC.
• Have received systemic anticancer treatment besides the specified cCRT.
• Any unresolved toxicity CTCAE > Grade 2 from the prior cCRT. Patients with
irreversible
toxicity that is not reasonably expected to be exacerbated by study treatment
may be
included (eg, hearing loss) after consultation with the medical monitor.
• Any grade pneumonitis from prior cCRT.
• Active autoimmune diseases or history of autoimmune diseases that may
relapse.
• Any active malignancy <= 2 years before the first dose of study drug(s) except
for the specific
cancer under investigation in this study and any locally recurring cancer that
has been treatedcuratively.
• Any conditions that required systemic treatment with either corticosteroids
(> 10 mg daily ofprednisone [in Japan, prednisolone] or equivalent) or other
immunosuppressive medication
<= 14 days before the first dose of study drug(s).
• History of interstitial lung disease, non-infectious pneumonitis, or
uncontrolled lung diseases
including pulmonary fibrosis, acute lung diseases, etc.
• Infections (including tuberculosis infection, etc) that required systemic
antibacterial,
antifungal, or antiviral therapy within 14 days before the first dose of study
drug(s).
• A history of severe hypersensitivity reactions to other monoclonal antibodies
or history of
hypersensitivity to the ingredients of tislelizumab or ociperlimab.
• Receipt of any immunotherapy (eg, interleukin, interferon, thymosin [not
approved in
Japan], etc) or any investigational therapies within 14 days or 5 half-lives
(whichever is
longer) before the first dose of study treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• PFS by the IRC, defined as the time from the date of randomization to the<br /><br>date of first documentation of disease progression as assessed<br /><br>by the IRC per RECIST v1.1 or death, whichever occurs first </p><br>