Skip to content

A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, with Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503920-14-00
Acronym
BO42777
Enrollment
39
Registered
2024-02-13
Start date
2024-01-02
Completion date
Unknown
Last updated
2025-08-11

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

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Brief summary

1. Progression-free survival (PFS), as determined by Blinded independent central review (BICR) per RECIST v1.1

Detailed description

1. PFS, defined as the time from randomization to the first documented disease progression, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurs first, 2. Time to central nervous system (CNS) progression, as determined by BICR and investigator per RECIST v1.1, 3. Distant metastasis-free survival (DMFS), as determined by BICR and investigator per RECIST v1.1, 4. Objective response rate (ORR), as determined by BICR and investigator per RECIST v1.1, 5. Duration of response (DOR), as determined by BICR and investigator per RECIST v1.1, 6. Overall survival (OS), 7. Time-to-confirmed deterioration (TTCD), in the following patient-reported scales and lung cancer symptoms: Physical functioning, Role functioning, Cough, Chest pain, Dyspnea, 8. Change from baseline score as measured through the use of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at 5, 11, and 17 months in the following patient-reported scales and lung cancer symptoms: Physical functioning, Role functioning, Cough, Chest pain, Dyspnea, 9. Incidence, type, and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 10. Changes in vital signs, physical findings, and clinical laboratory results during and following administration of protocol-specified investigational medicinal products (IMPs)

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Progression-free survival (PFS), as determined by Blinded independent central review (BICR) per RECIST v1.1

Secondary

MeasureTime frame
1. PFS, defined as the time from randomization to the first documented disease progression, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurs first, 2. Time to central nervous system (CNS) progression, as determined by BICR and investigator per RECIST v1.1, 3. Distant metastasis-free survival (DMFS), as determined by BICR and investigator per RECIST v1.1, 4. Objective response rate (ORR), as determined by BICR and investigator per RECIST v1.1, 5. Duration of response (DOR), as determined by BICR and investigator per RECIST v1.1, 6. Overall survival (OS), 7. Time-to-confirmed deterioration (TTCD), in the following patient-reported scales and lung cancer symptoms: Physical functioning, Role functioning, Cough, Chest pain, Dyspnea, 8. Change from baseline score as measured through the use of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at 5, 11, and 17 months in the follo

Countries

Belgium, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed

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