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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.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502738-18-00
Acronym
BGB-LC-201
Enrollment
22
Registered
2023-08-22
Start date
2023-09-15
Completion date
Unknown
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Non-small Cell Lung Cancer, Non-small Cell Lung Cancer

Brief summary

Confirmed overall response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1

Detailed description

Progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and disease control rate (DCR) as assessed by the investigator per RECIST v1.1., The incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE v5.0 in reference arms and experimental arms., Plasma or serum concentrations of tislelizumab and investigational agents at specified timepoints., Immunogenic responses to tislelizumab and investigational protein therapeutics, evaluated through the detection of antidrug antibodies (ADA).

Interventions

DRUGTislelizumab
DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion
DRUGALIMTA 500 mg powder for concentrate for solution for infusion
DRUGApealea 60 mg powder for solution for infusion.
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

Sponsors

Beigene Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Confirmed overall response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1

Secondary

MeasureTime frame
Progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and disease control rate (DCR) as assessed by the investigator per RECIST v1.1., The incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE v5.0 in reference arms and experimental arms., Plasma or serum concentrations of tislelizumab and investigational agents at specified timepoints., Immunogenic responses to tislelizumab and investigational protein therapeutics, evaluated through the detection of antidrug antibodies (ADA).

Countries

France, Italy, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026