Informations générales (source: ClinicalTrials.gov)
A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined With AB154 in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (ARC-10)
Interventional
Phase 3
Arcus Biosciences, Inc. (Voir sur ClinicalTrials)
février 2021
juillet 2027
29 juin 2024
This is a phase 3 study to evaluate zimberelimab (AB122) combined with domvanalimab
(AB154) compared to pembrolizumab in front-line, PD-L1-high, locally advanced or
metastatic NSCLC.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 29/03/2024 01:30:45 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Poitiers - Poitiers - France | Contact (sur clinicalTrials) | ||||
| CHU Rennes Hopital Pontchaillou - Rennes - France | Contact (sur clinicalTrials) | ||||
| Hôpital Ambroise Paré - Boulogne-Billancourt - France | Contact (sur clinicalTrials) | ||||
| Hopital Larrey - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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:
1. Have no evidence of progression by neurologic symptoms or signs for at least 4
weeks prior to the first dose.
2. 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. 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.
3. Carcinomatous meningitis is excluded regardless of clinical stability.
- 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:
1. Have no evidence of progression by neurologic symptoms or signs for at least 4
weeks prior to the first dose.
2. 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. 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.
3. Carcinomatous meningitis is excluded regardless of clinical stability.
- 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.
Other protocol defined Inclusion/Exclusion criteria may apply.