Informations générales (source: ClinicalTrials.gov)
Master Protocol: A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
Interventional
Phase 2
BeiGene (Voir sur ClinicalTrials)
mars 2023
juillet 2025
03 octobre 2024
The purpose of this study is to assess the antitumor activity, safety, and tolerability
of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is
structured as a master protocol with separate sub- studies. Sub-study 1 includes
participants with non-small cell lung cancer (NSCLC) with high programmed cell death
protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with
NSCLC with low or negative (PD-L1) expression (< 50%).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:38 | Contact (sur clinicalTrials) | |||
| 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 Nantes Hopital Nord Laennec - 44805 - SaintHerblain - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is
locally advanced or recurrent and not eligible for curative surgery and/or
definitive chemoradiotherapy, or metastatic NSCLC.
2. No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior
adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy
for locally advanced disease is allowed provided the last dose of chemotherapy
and/or radiotherapy occurred at least 6 months before randomization/enrollment.
3. Evaluable tumor PD-L1 expression as determined by a local laboratory or by central
laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1
expression will not be eligible for this study.
4. At least 1 measurable lesion as defined per RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
1. Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is
locally advanced or recurrent and not eligible for curative surgery and/or
definitive chemoradiotherapy, or metastatic NSCLC.
2. No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior
adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy
for locally advanced disease is allowed provided the last dose of chemotherapy
and/or radiotherapy occurred at least 6 months before randomization/enrollment.
3. Evaluable tumor PD-L1 expression as determined by a local laboratory or by central
laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1
expression will not be eligible for this study.
4. At least 1 measurable lesion as defined per RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
1. Has mixed small cell lung cancer.
2. Participants with known actionable mutations (including but not limited to EGFR,
ALK, BRAF, RET, and ROSI mutations) for which a targeted therapy is available per
local standard of care.
3. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any
other antibody or drug targeting T-cell costimulation or immune checkpoint pathways.
Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies
targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a
treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy
prior to radiologic recurrence of disease.
4. Has received any Chinese herbal medicine or Chinese patent medicines used to control
cancer ≤ 14 days before randomization/enrollment.
5. Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active
autoimmune diseases.
NOTE: Other protocol and sub-study protocol defined criteria may apply