IFINATAMAB DERUXTECAN for Small cell lung cancer | Extensive-stage small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Sign and date the informed consent form prior to the start of any study-specific qualification procedures."}
• {"criterion_text":"- Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed."}
• {"criterion_text":"- Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC.)."}
• {"criterion_text":"- The subject must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content."}
• {"criterion_text":"- Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy-free interval of ≥30 days."}
• {"criterion_text":"- Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator."}
• {"criterion_text":"- Has documentation of radiological disease progression on or after the most recent systemic therapy."}
• {"criterion_text":"- Has ECOG PS of ≤1 within 7 days before C1D1."}
• {"criterion_text":"- Has no evidence of brain or leptomeningeal disease (spinal cord or central nervous system [CNS] metastases based on history and physical examination. For subjects with evidence of brain or leptomeningeal disease, they may be eligible if condition has been treated and a lack of progression within 4 weeks prior to initiation of study drug has been radiologically documented. Subjects must require no treatment with steroids or anticonvulsants and have a stable neurologic status for at least 2 weeks prior to the first dose of study drug."}

Exclusion criteria

• {"criterion_text":"- Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd."}
• {"criterion_text":"- Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities."}
• {"criterion_text":"- Has received any of the comparators used in this study or any topoisomerase I inhibitor."}
• {"criterion_text":"- Has inadequate washout period before randomization as specified in the protocol ."}
• {"criterion_text":"- Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event."}
• {"criterion_text":"- Has uncontrolled or significant cardiovascular disease."}
• {"criterion_text":"- Has clinically significant corneal disease."}
• {"criterion_text":"- Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Subjects may be eligible if they had history of radiation pneumonitis that did not require steroids."}
• {"criterion_text":"- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of randomization, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc) and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen."}

Primary endpoints

• {"endpoint_text":"- Objective Response Rate (ORR): The percentage of participants who show a confirmed complete response (no detectable cancer) or confirmed partial response (reduced tumor size) as assessed by blinded independent central review.","definition_or_measurement_approach":"Confirmed complete response or confirmed partial response as assessed by blinded independent central review."}
• {"endpoint_text":"- Overall Survival (OS): The time interval from the date of randomization to the date of death due to any cause.","definition_or_measurement_approach":"Time interval from randomization date to date of death from any cause."}

Secondary endpoints

• {"endpoint_text":"- ORR as assessed by the investigator, progression-free survival, duration of response, disease control rate, time to response, PROs measures of health-related quality of life, adverse events, antidrug antibody prevalence, correlation of B7-H3 protein expression in tumor tissue with clinical outcomes, and PK.","definition_or_measurement_approach":"As written: includes investigator-assessed ORR, PFS, DOR, disease control rate, time to response, patient-reported outcomes (health-related QoL), safety (AEs), antidrug antibody prevalence, correlation of tumor B7-H3 expression with outcomes, and pharmacokinetics (PK)."}

Methods

• Physician Referral Letters (documents listed: Physician Referral Letter / Dr-to-Patient Letter) — channel: HCP-to-patient referral; target audience: treating physicians and potential patient candidates; country-specific versions provided (examples: Spain, Germany, Netherlands, Hungary, Romania, France, Italy, Portugal, Poland, Czechia).
• Patient Brochures and Patient Wallet Cards — channel: printed/patient-facing materials distributed at sites; target audience: potential participants; country-specific/local-language versions available (EN, ES, FR, DE, IT, NL, PT, HU, PL, RO, GR/CZ etc.).
• Participant Study Guides / Patient Guides / Site pocket guides — channel: study/site materials to inform participants and site staff; target audience: enrolled participants and site staff; localized per country.
• Patient-facing digital content: patient-facing video transcripts, push notifications, PatientApp/BYOD materials and Patient FAQ — channel: digital/remote engagement; target audience: participants using the study app or digital tools (documents referencing PatientApp, push notifications, BYOD No PII, Patient FAQ, video transcript).
• Site-level recruitment procedures and study guides (K1/K2 recruitment arrangements, recruitment procedures) — channel: site-based recruitment workflows and HCP communications; target audience: site investigators and clinical staff; country-specific procedures and documented local-language materials listed.

Primary sponsor

Full Name

Daiichi Sankyo Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA Limited

Responsibilities

Multiple sponsor duties (codes listed in dossier)

Name

PPD Development L.P.

Responsibilities

PK/ADA Analysis

Name

Bioclinica Inc.

Responsibilities

Imaging services; ILD Adjudication; Central Imaging (multiple Bioclinica entities)

Name

Medable Inc.

Responsibilities

ePRO questionnaires

Name

Suvoda LLC

Responsibilities

sponsorDuties code: 3 (operational support)

Third parties

• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,2,5,8,9","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"Clin supply packaging, import/storage and investigational product (IP) shipment","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"Other Local lab, Imaging, Ophthalmology services for Greek sites; code: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"Archival Tumor Tissue Sample, Fresh Tumor Biopsy Sample","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc. (Princeton address)","duties_or_roles":"Imaging services","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc. (Philadelphia address)","duties_or_roles":"ILD Adjudication","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Japan","full_name":"Daiichi Sankyo Co. Ltd.","duties_or_roles":"Archival Tumor Tissue Sample, Fresh Tumor Biopsy Sample, Blood Sample","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc. (another address)","duties_or_roles":"Central Imaging","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Cisys Inc.","duties_or_roles":"Software as service for adjudication and eligibility","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties code: 8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"ePRO questionnaires","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Woodley Equipment Company Limited","duties_or_roles":"Provide ECGs if required for sites","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Archival Tumor Tissue Sample Fresh Tumor Biopsy Sample (B7-H3 IHC assay)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Fisher Bioservices Inc.","duties_or_roles":"long term storage","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Iqvia RDS Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: 1,12,8","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development L.P.","duties_or_roles":"PK/ADA Analysis","organisation_type":"Pharmaceutical company"}