TELISOTUZUMAB ADIZUTECAN for Non-small cell lung cancer (non-squamous)

Stratification factors

• c-Met IHC status

Inclusion criteria

• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1."}
• {"criterion_text":"- All participants must consent to provide recently obtained FFPE tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met IHC testing and study stratification. c-Met IHC results are required prior to randomization."}
• {"criterion_text":"- Participants must have at least one non-irradiated measurable disease per RECIST version 1.1. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans."}
• {"criterion_text":"- Any toxicities from prior systemic anti-cancer therapy must have resolved to CTCAE Grade 1 or baseline level (except for alopecia [any grade] or Grade ≤ 2 peripheral neuropathy)."}
• {"criterion_text":"- Participants should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months."}

Exclusion criteria

• {"criterion_text":"- History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest CT scan."}
• {"criterion_text":"- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis."}
• {"criterion_text":"- History of any malignancy other than disease under study except for a. Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator. b. Successfully treated nonmelanoma skin cancer. c. Localized carcinoma in situ of the cervix. d. Breast Cancer; lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured."}
• {"criterion_text":"- Participants has leptomeningeal disease, or subject has spinal cord compression not definitively treated with surgery or radiation."}

Primary endpoints

• {"endpoint_text":"- Phase 2: Objective response (OR) based on Blinded independent central review (BICR) assessment per RECIST version 1.1","definition_or_measurement_approach":"Objective response assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1."}
• {"endpoint_text":"- Phase 3: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.","definition_or_measurement_approach":"Progression-free survival assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- Phase 2: PFS based on BICR assessment per RECIST version 1.1.","definition_or_measurement_approach":"Progression-free survival assessed by Blinded Independent Central Review (BICR) per RECIST v1.1."}
• {"endpoint_text":"- Phase 2: Duration of response (DoR) based on BICR assessment per RECIST version 1.1.","definition_or_measurement_approach":"Duration of response assessed by BICR per RECIST v1.1."}
• {"endpoint_text":"- Phase 2: Disease control rate (DC) based on BICR assessment per RECIST version 1.1.","definition_or_measurement_approach":"Disease control rate assessed by BICR per RECIST v1.1."}
• {"endpoint_text":"- Phase 2: Overall Survival","definition_or_measurement_approach":"Overall survival (time to death from any cause)."}
• {"endpoint_text":"- Phase 3: Overall Survival","definition_or_measurement_approach":"Overall survival (time to death from any cause)."}
• {"endpoint_text":"- Phase 3: OR based on BICR assessment per RECIST version 1.1.","definition_or_measurement_approach":"Objective response assessed by BICR per RECIST v1.1."}
• {"endpoint_text":"- Phase 3: DoR based on BICR assessment per RECIST version 1.1.","definition_or_measurement_approach":"Duration of response assessed by BICR per RECIST v1.1."}
• {"endpoint_text":"- Phase 3: DC based on BICR assessment per RECIST version 1.1.","definition_or_measurement_approach":"Disease control assessed by BICR per RECIST v1.1."}
• {"endpoint_text":"- Phase 3: Change from baseline at Week 12 in physical functioning as measured by the EORTC QLQ‑C30","definition_or_measurement_approach":"Change from baseline at Week 12 measured by the physical functioning domain of the EORTC QLQ-C30 questionnaire."}
• {"endpoint_text":"- Phase 3: Change from baseline at Week 12 in key lung cancer symptoms as measured by the EORTC QLQ-LC13.","definition_or_measurement_approach":"Change from baseline at Week 12 measured by the EORTC QLQ-LC13 symptom scales."}
• {"endpoint_text":"- Phase 3: Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30.","definition_or_measurement_approach":"Change from baseline at Week 12 in Global Health Status/Quality of Life measured by the EORTC QLQ-C30."}

Belgium

Earliest CTIS Part Ii Submission Date

24-07-2025

Latest Decision Or Authorization Date

25-08-2025

Processing Time Days

32

Number Of Sites

4

Number Of Participants

9

Italy

Earliest CTIS Part Ii Submission Date

21-05-2025

Latest Decision Or Authorization Date

04-11-2025

Processing Time Days

167

Number Of Sites

5

Number Of Participants

18

Spain

Earliest CTIS Part Ii Submission Date

21-07-2025

Latest Decision Or Authorization Date

24-11-2025

Processing Time Days

126

Number Of Sites

5

Number Of Participants

15

Portugal

Earliest CTIS Part Ii Submission Date

12-08-2025

Latest Decision Or Authorization Date

25-08-2025

Processing Time Days

13

Number Of Sites

3

Number Of Participants

8

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Clario

Responsibilities

Central Imaging

Name

Iqvia Biotech Limited

Responsibilities

code 3

Name

Labcorp Central Laboratory Services SARL

Responsibilities

code 4

Name

Medidata Solutions Inc.

Responsibilities

eCOA/ePRO

Name

WCG Clinical Inc.

Responsibilities

External ILD Adjudication

Name

Greenphire LLC

Responsibilities

Subject Reimbursement

Name

Veeva Systems Inc.

Responsibilities

code 7

Name

Ventana Medical Systems Inc.

Responsibilities

code 4

Third parties

• {"country":"United States","full_name":"Clario","duties_or_roles":"Central Imaging","organisation_type":"Industry"}
• {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA/ePRO","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Subject Reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"External ILD Adjudication","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}