IFINATAMAB DERUXTECAN for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Histologically or cytologically confirmed diagnosis of Stage IV non-squamous non-small cell lung cancer (NSCLC)"}
• {"criterion_text":"- Participant/participants of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test; and is not breastfeeding and uses a highly effective contraceptive method"}
• {"criterion_text":"- Archival tumor tissue sample of a tumor lesion not previously irradiated has been provided"}
• {"criterion_text":"- Has provided tissue prior to treatment randomization from a newly obtained formalin-fixed sample from a new biopsy"}
• {"criterion_text":"- Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)"}
• {"criterion_text":"- Participants who are hepatitis B surface antigen (HBsAg) positive have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization"}
• {"criterion_text":"- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening"}
• {"criterion_text":"- Documented disease progression per RECIST 1.1 after receiving an anti-programmed cell death 1 protein (PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy"}
• {"criterion_text":"- Confirmation per local test report that epidermal growth factor receptor negative (EGFR-), anaplastic lymphoma kinase negative (ALK-), or c ros oncogene 1 negative (ROS1-) directed therapy is not indicated as primary therapy"}
• {"criterion_text":"- Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR"}
• {"criterion_text":"- Life expectancy of at least 3 months"}
• {"criterion_text":"- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization"}
• {"criterion_text":"- Is an individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent"}
• {"criterion_text":"- Has adequate organ function"}
• {"criterion_text":"- If capable of producing sperm refrains from donating sperm plus either abstains from penile-vaginal intercourse or uses a penile/external condom, with contraceptive use consistent with local regulations"}

Exclusion criteria

• {"criterion_text":"- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements"}
• {"criterion_text":"- Has inadequate washout period prior to randomization"}
• {"criterion_text":"- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention"}
• {"criterion_text":"- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy"}
• {"criterion_text":"- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration"}
• {"criterion_text":"- Has known additional malignancy that is progressing or has required active treatment within the past 3 years"}
• {"criterion_text":"- Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis"}
• {"criterion_text":"- Has evidence of any leptomeningeal disease"}
• {"criterion_text":"- Has history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and/or suspected ILD/pneumonitis"}
• {"criterion_text":"- Has active autoimmune disease that has required systemic treatment in the past 2 years"}
• {"criterion_text":"- Has active infection requiring systemic therapy"}
• {"criterion_text":"- Received radiation therapy to the lung"}
• {"criterion_text":"- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease"}
• {"criterion_text":"- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease"}
• {"criterion_text":"- Has known history of, or active, neurologic paraneoplastic syndrome"}
• {"criterion_text":"- Has history of allogeneic tissue/solid organ transplant"}
• {"criterion_text":"- Have not adequately recovered from major surgery or have ongoing surgical complications"}
• {"criterion_text":"- Has uncontrolled or significant cardiovascular disorder prior to randomization"}
• {"criterion_text":"- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses"}
• {"criterion_text":"- Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline"}
• {"criterion_text":"- Has known severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients"}
• {"criterion_text":"- Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including HIV infection)"}
• {"criterion_text":"- Has clinically significant corneal disease"}
• {"criterion_text":"- Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids"}

Primary endpoints

• {"endpoint_text":"- Objective Response (OR)","definition_or_measurement_approach":"Objective response per RECIST 1.1 as assessed by blinded independent central review (BICR) (as stated in trial objectives)."}
• {"endpoint_text":"- Percentage of participants with at least one adverse event (AE)","definition_or_measurement_approach":"Proportion/percentage of participants reporting ≥1 adverse event (AE) (safety endpoint, measured as percentage of participants with at least one AE)."}
• {"endpoint_text":"- Percentage of participants who discontinued medication due to an AE","definition_or_measurement_approach":"Proportion/percentage of participants who permanently discontinued study medication because of an adverse event."}

Secondary endpoints

• {"endpoint_text":"- Duration Of Response (DOR)","definition_or_measurement_approach":"Duration of response per RECIST 1.1 as assessed by blinded independent central review (BICR) (as stated in secondary objectives)."}
• {"endpoint_text":"- Progression-Free Survival (PFS)","definition_or_measurement_approach":"Progression-free survival per RECIST 1.1 as assessed by BICR (time from randomization to progression or death)."}
• {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Overall survival (time from randomization to death from any cause)."}

Germany

Earliest CTIS Part Ii Submission Date

18-07-2025

Latest Decision Or Authorization Date

08-12-2025

Processing Time Days

143

Number Of Sites

2

Number Of Participants

4

Hungary

Earliest CTIS Part Ii Submission Date

31-07-2025

Latest Decision Or Authorization Date

08-12-2025

Processing Time Days

130

Number Of Sites

3

Number Of Participants

12

Italy

Earliest CTIS Part Ii Submission Date

04-07-2025

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

158

Number Of Sites

4

Number Of Participants

4

Spain

Earliest CTIS Part Ii Submission Date

01-07-2025

Latest Decision Or Authorization Date

10-12-2025

Processing Time Days

154

Number Of Sites

2

Number Of Participants

8

Poland

Earliest CTIS Part Ii Submission Date

09-07-2025

Latest Decision Or Authorization Date

08-12-2025

Processing Time Days

152

Number Of Sites

4

Number Of Participants

7

Greece

Earliest CTIS Part Ii Submission Date

15-05-2025

Latest Decision Or Authorization Date

08-12-2025

Processing Time Days

207

Number Of Sites

2

Number Of Participants

6

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International Corp.

Responsibilities

Medical information (Physician Consulting)

Name

PPD Global Central Labs

Name

ICON

Responsibilities

Central Imaging/BICR

Name

Almac Clinical Technologies LLC

Name

Ventana (Roche Tissue Diagnostics)

Third parties

• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting)","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"ICON","duties_or_roles":"Central Imaging/BICR","organisation_type":"Industry"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Ventana (Roche Tissue Diagnostics)","duties_or_roles":"","organisation_type":"Industry"}