A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

JRCT ID: jRCT2031230631

Registered date:14/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: relapsed small cell lung cancer (SCLC)
• Date of first enrollment: 22/08/2024
• Target sample size: 540
• Countries of recruitment: Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,France,Japan,Germany,Japan,Hungary,Japan,Italy,Japan,Korea,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Rumania,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan,Czechia,Japan,Greece,Japan
• Study type: Interventional

Intervention(s)

Experimental: Ifinatamab deruxtecan (I-DXd)
I-DXd at a dose of 12 mg/kg is administered via an intravenous infusion Q3W.

Active Comparator: Treatment of Physician's Choice
Participants will receive treatment per local standard of care (SOC)
Drug: Amrubicin
Drug: Lurbinectedin
Drug: Topotecan

Outcome(s)

• Primary Outcome: Objective response rate (ORR) per blinded independent central review (BICR), overall survival (OS)

Secondary Outcome

efficacy (objective response rate (ORR), progression-free survival (PFS), duration of response (DoR), disease control rate (DCR), time to response (TTR))
Patient-reported general health status and symptoms
safety
immunogenicity
B7-H3 protein expression and its relationship
pharmacokinetic parameters

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
2. Adults >=18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
3. Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
4. The subject must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
5. 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.
6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
7. Has documentation of radiological disease progression on or after the most recent systemic therapy.
8. Has ECOG PS of <=1 within 7 days prior to Cycle 1 Day 1 (C1D1).
9. Has no evidence of brain or leptomeningeal disease (spinal cord or central nervous system [CNS] metastases) based on history and physical examination. 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.

Exclude criteria

1. Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
3. Has received any of the comparators used in this study or any topoisomerase I inhibitor
4. Has inadequate washout period before randomization as specified in the protocol.
5. Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
6. Has uncontrolled or significant cardiovascular disease.
7. Has clinically significant corneal disease.
8. Has history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.
9. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Secondary Sponsor: Merck Sharp & Dohme LLC
• Secondary ID(s): NCT06203210