IFINATAMAB DERUXTECAN for Small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Has histologically or cytologically confirmed small cell lung cancer (SCLC) that is extensive stage defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy"}
• {"criterion_text":"- Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample"}
• {"criterion_text":"- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)"}

Exclusion criteria

• {"criterion_text":"- Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure"}
• {"criterion_text":"- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids"}
• {"criterion_text":"- Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention"}
• {"criterion_text":"- Known additional malignancy that is progressing or has required active treatment within the past 3 years"}
• {"criterion_text":"- Untreated or symptomatic brain metastases"}
• {"criterion_text":"- Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive and/or detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA]), or hepatitis C (hepatitis C virus [HCV] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible."}
• {"criterion_text":"- Part 1 only: Radiation therapy to the lung >30 Gy within 6 months before the start of study intervention"}
• {"criterion_text":"- Part 1 only: Abdominal radiation within 4 weeks before start of study intervention"}
• {"criterion_text":"- Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone [LHRH]) within 2 weeks before start of study intervention"}
• {"criterion_text":"- Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer"}
• {"criterion_text":"- Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention"}
• {"criterion_text":"- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis"}
• {"criterion_text":"- Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention"}
• {"criterion_text":"- Part 1 only: Clinically significant corneal disease"}
• {"criterion_text":"- Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease"}
• {"criterion_text":"- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses"}
• {"criterion_text":"- Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART"}
• {"criterion_text":"- History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association > class II), and/or uncontrolled cardiac arrhythmia"}
• {"criterion_text":"- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention"}
• {"criterion_text":"- Active clinically significant infection requiring systemic therapy"}
• {"criterion_text":"- History of allogeneic tissue/solid organ transplant"}
• {"criterion_text":"- History of leptomeningeal disease"}

Primary endpoints

• {"endpoint_text":"- Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":""}
• {"endpoint_text":"- Part 1: Objective Response Rate (ORR)","definition_or_measurement_approach":"Per RECIST 1.1 (as stated in main objectives)"}

Secondary endpoints

• {"endpoint_text":"- Part 1, Part 2 (Arm 5 and Arm 6), and Part 3 (Arm 7): Duration of Response (DOR)","definition_or_measurement_approach":"Per RECIST 1.1 (stated in secondary objectives)"}
• {"endpoint_text":"- Part 1, Part 2 (Arm 6), and Part 3 (Arm 7): Progression-Free Survival (PFS)","definition_or_measurement_approach":"Per RECIST 1.1 (stated in secondary objectives)"}
• {"endpoint_text":"- Part 2 (Arm 5 and Arm 6) and Part 3 (Arm 7): ORR","definition_or_measurement_approach":"Per RECIST 1.1 (stated in secondary objectives)"}
• {"endpoint_text":"- Maximum Concentration (Cmax) of gocatamig","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cmax of ifinatamab deruxtecan (I-DXd)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cmax of Anti-B7-H3 Antibody","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cmax of Deruxtecan (DXd)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cmax of durvalumab","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to maximum concentration (Tmax) of gocatamig","definition_or_measurement_approach":""}
• {"endpoint_text":"- Tmax of I-DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Tmax of Anti-B7-H3 Antibody","definition_or_measurement_approach":""}
• {"endpoint_text":"- Tmax of DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of gocatamig","definition_or_measurement_approach":""}
• {"endpoint_text":"- AUCt of I-DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- AUCt of Anti-B7-H3 Antibody","definition_or_measurement_approach":""}
• {"endpoint_text":"- AUCt of DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- erminal Half-Life (t1/2) of gocatamig","definition_or_measurement_approach":""}
• {"endpoint_text":"- t1/2 of I-DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- t1/2 of Anti-B7-H3 Antibody","definition_or_measurement_approach":""}
• {"endpoint_text":"- t1/2 of DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Steady State Maximum Concentration (Cmax,ss) of gocatamig","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cmax,ss of I-DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cmax,ss of Anti-B7-H3 Antibody","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cmax,ss of DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cmax,ss of durvalumab","definition_or_measurement_approach":""}
• {"endpoint_text":"- Steady State Ctrough (Ctrough,ss) of gocatamig","definition_or_measurement_approach":""}
• {"endpoint_text":"- Ctrough,ss of I-DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Ctrough,ss of Anti-B7-H3 Antibody","definition_or_measurement_approach":""}
• {"endpoint_text":"- Ctrough,ss of DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Ctrough,ss of durvalumab","definition_or_measurement_approach":""}
• {"endpoint_text":"- Steady State Time to Maximum Concentration (Tmax,ss) of gocatamig","definition_or_measurement_approach":""}
• {"endpoint_text":"- Tmax,ss of I-DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Tmax,ss of Anti-B7-H3 Antibody","definition_or_measurement_approach":""}
• {"endpoint_text":"- Tmax,ss of DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Area Under the Steady State Concentration-Time Curve Over Dosing Interval t (AUCt,ss) of gocatamig","definition_or_measurement_approach":""}
• {"endpoint_text":"- AUCt,ss of I-DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- AUCt,ss of Anti-B7-H3 Antibody","definition_or_measurement_approach":""}
• {"endpoint_text":"- AUCt,ss of DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- 39.\tSteady state t1/2 (t1/2,ss) of gocatamig","definition_or_measurement_approach":""}
• {"endpoint_text":"- t1/2,ss of I-DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- t1/2,ss of Anti-B7-H3 Antibody","definition_or_measurement_approach":""}
• {"endpoint_text":"- t1/2,ss of DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Accumulation Ratio (AC) of gocatamig","definition_or_measurement_approach":""}
• {"endpoint_text":"- AC of I-DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- AC of Anti-B7-H3 Antibody","definition_or_measurement_approach":""}
• {"endpoint_text":"- AC of DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of Anti-Drug Antibodies (ADAs) Against gocatamig","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of ADAs Against I-DXd","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of ADAs against durvalumab","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

17-02-2025

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

382

Number Of Sites

8

Number Of Participants

59

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA Limited

Responsibilities

Bl for Citokines

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services)

Name

Almac Clinical Services LLC

Responsibilities

sponsorDuties code 3

Name

PPD Global Central Labs

Responsibilities

Central lab – collect and send to 3rd party labs

Name

PPD BioA

Responsibilities

Analysis of I-DXd ADA and PK

Name

Bioclinica Inc.

Responsibilities

sponsorDuties code 8

Name

Smithers PDS LLC

Responsibilities

Analysis of PK and ADA for MK6070

Third parties

• {"country":"United Kingdom","full_name":"Almac Diagnostics","duties_or_roles":"RNA-seg WES – tissue samples And Bl for Genetic Analysis","organisation_type":"Industry"}
• {"country":"United States","full_name":"Roche Tissue Diagnostics","duties_or_roles":"Tissue testing for DLL3 and B7H3","organisation_type":"Industry"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Bl for Citokines","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties code 3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Central lab – collect and send to 3rd party labs","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Median Technologies","duties_or_roles":"Imaging Vendor","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta Biosciences","duties_or_roles":"Ref Lab – Immunophenotyping","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code 8","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"Analysis of PK and ADA for MK6070","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD BioA","duties_or_roles":"Analysis of I-DXd ADA and PK","organisation_type":"Industry"}