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Phase 3 Study Comparing Zimberelimab with Domvanalimab to Pembrolizumab in Advanced Non-Small Cell Lung Cancer
EU CTIS ID: 2022-503071-28-00
What this study is testing
To evaluate the efficacy of zimberelimab and domvanalimab combination therapy compared to pembrolizumab in OS (Arm D vs Arm E)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed, treatment naïve, locally advanced or metastatic (stage IIIB IV per AJCC version 8), squamous or non-squamous NSCLC with documented high PD L1 expression (TC ≥ 50%) as determined by the VENTANA SP263 IHC assay, as assessed by central laboratories).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Must have at least 1 measurable lesion per RECIST v1.1
- Adequate organ and marrow function
- If a participant has brain or meningeal metastases, the participant must meet the following criteria: a. Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose, b) Participants with previously treated brain metastases may participate provided they have stable central nervous system (CNS) disease for at least 4 weeks prior to enrollment, c) Stable CNS disease is defined as resolution of all neurologic symptoms to baseline, having no evidence of new or enlarging brain metastases, and not requiring use of corticosteroids for CNS disease for at least 14 days prior to the start of study treatment. Participants who have had brain metastases resected or have received whole brain radiotherapy ending at least 4 weeks (or stereotactic radiotherapy ending at least 2 weeks) prior to initiation of study treatment are permitted d) Carcinomatous meningitis is excluded regardless of clinical stability
You likely can't join if
- Presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved by local health authority and available
- Use of any live vaccines against infectious diseases within 28 days of first dose
- Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
- Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- Bangladesh
- United States
- Australia
- Bosnia and Herzegovina
- China
- Brazil
- Thailand
- Korea, Republic of
- South Africa
- Malaysia
- Vietnam
- Mexico
- Philippines
- Serbia
- Taiwan
- Switzerland
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong; Bangladesh; United States; Australia; Bosnia and Herzegovina; China and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.