Protein - Other for Locally advanced or metastatic non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n- Histologically or cytologically documented locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC who are not eligible for curative surgery and/or definitive chemoradiotherapy\n- No prior systemic treatment for metastatic NSCLC\n- Known tumor PD-L1 status\n- Confirmed availability of representative tumor specimens\n- Adequate hematologic and end-organ function"}

Exclusion criteria

• {"criterion_text":"- NSCLC known to have a mutation in the EGFR gene or an ALK fusion oncogene. Known targetable c-ROS oncogene 1 (ROS1), BRAFV600E or RET proto-oncogene genomic aberrations\n- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Untreated or clinically unstable spinal cord compression\n- History of leptomeningeal disease\n- Uncontrolled tumor-related pain. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently)\n- Active or history of autoimmune disease or immune deficiency"}

Primary endpoints

• {"endpoint_text":"- 1. PFS after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1","definition_or_measurement_approach":"Time from randomization to first occurrence of disease progression or death from any cause; progression determined by investigator according to RECIST v1.1."}
• {"endpoint_text":"- 2. ORR, defined as the proportion of participants with a complete response or a partial response on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1","definition_or_measurement_approach":"Proportion of participants with confirmed complete or partial response on two consecutive occasions ≥4 weeks apart; responses determined by investigator according to RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- 1. OS after randomization, defined as the time from randomization to death from any cause","definition_or_measurement_approach":"Time from randomization to death from any cause."}
• {"endpoint_text":"- 2. Duration of response for participants with confirmed objective response, defined as the time from the first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1","definition_or_measurement_approach":"Time from first occurrence of confirmed objective response to disease progression or death; determined by investigator per RECIST v1.1."}
• {"endpoint_text":"- 3. PFS and OS in participants with PD-L1 expression, defined as tumor cells < 1%, 1%-49%, and < 50%, as assessed by retrospective central PD-L1 testing","definition_or_measurement_approach":"PFS and OS analysed by PD-L1 expression groups assessed by retrospective central PD-L1 testing; strata defined in the protocol as tumor cells <1%, 1%-49%, and <50%."}
• {"endpoint_text":"- 4. Change from baseline to Week 12 in patient-reported outcomes of lung cancer symptoms, physical functioning, role functioning, and global health status/quality of life, as assessed through the use of the European Organisation for Research and Treatment of Cancer Item Libraries","definition_or_measurement_approach":"Change from baseline to Week 12 in PRO measures of lung cancer symptoms, physical functioning, role functioning, and global health/QoL using EORTC item libraries."}
• {"endpoint_text":"- 5. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 The severity of cytokine release syndrome will also be determined according to the American Society for Transplantation and Cellular Therapy Consensus Grading Scale.","definition_or_measurement_approach":"Incidence and severity of AEs graded by NCI CTCAE v5.0; CRS severity graded by ASTCT Consensus Grading Scale."}
• {"endpoint_text":"- 6. Maximum concentration of tobemstomig","definition_or_measurement_approach":"Pharmacokinetic measure: Cmax of tobemstomig."}
• {"endpoint_text":"- 7. Time of maximum concentration of tobemstomig","definition_or_measurement_approach":"Pharmacokinetic measure: Tmax of tobemstomig."}
• {"endpoint_text":"- 8. Clearance of tobemstomig","definition_or_measurement_approach":"Pharmacokinetic measure: clearance (CL) of tobemstomig."}
• {"endpoint_text":"- 9. Volume of distribution at steady state of tobemstomig","definition_or_measurement_approach":"Pharmacokinetic measure: volume of distribution at steady state (Vss) of tobemstomig."}
• {"endpoint_text":"- 10. Area under the concentration-time curve tobemstomig","definition_or_measurement_approach":"Pharmacokinetic measure: AUC of tobemstomig."}
• {"endpoint_text":"- 11. Half‑life of tobemstomig","definition_or_measurement_approach":"Pharmacokinetic measure: half-life (t1/2) of tobemstomig."}
• {"endpoint_text":"- 12. Concentrations of tobemstomig in serum at specified timepoints","definition_or_measurement_approach":"Pharmacokinetic measure: serum concentrations of tobemstomig at specified sampling timepoints."}
• {"endpoint_text":"- 13.Prevalence of ADAs to tobemstomig at baseline and incidence of ADAs to tobemstomig during the study","definition_or_measurement_approach":"Immunogenicity: prevalence of anti-drug antibodies at baseline and incidence during the study."}

Methods

• Patient recruitment delegated to third-party Greenphire LLC (role listed as 'Patient Recruitement').
• Communication of study information to treating physicians/clinicians (document 'K2_Communication Study Info to Doctors' listed in submitted documents).

Italy

Latest Decision Or Authorization Date

31-03-2025

Number Of Sites

7

Number Of Participants

21

Germany

Latest Decision Or Authorization Date

28-03-2025

Number Of Sites

1

Number Of Participants

15

Spain

Latest Decision Or Authorization Date

26-03-2025

Number Of Sites

6

Number Of Participants

15

Belgium

Latest Decision Or Authorization Date

28-03-2025

Number Of Sites

4

Number Of Participants

12

France

Latest Decision Or Authorization Date

26-03-2025

Number Of Sites

6

Number Of Participants

18

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

IQVIA Limited

Responsibilities

Sponsor duty code: 1 (as listed in CTIS third-party duties)

Name

Almac Clinical Technologies LLC

Responsibilities

Sponsor duty code: 3 (as listed in CTIS third-party duties)

Third parties

• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"General Laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Speciality Laboratory; Biomarker Vendor","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Recruitement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"Sponsor duty code: 3","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duty code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Median Technologies","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}