A Phase 3 Study of I-DXd in Subjects with Relapsed SCLC

Phase 3

• Conditions: relapsed small cell lung cancer (SCLC)

• Registration Number: JPRN-jRCT2031230631
• Lead Sponsor: Inoguchi Akihiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-14
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 468

Inclusion 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 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 at least one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy.
6. Has at least one 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.
9. Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy.

Exclusion Criteria

1. Has received prior treatment with orlotamab, enoblituzumab, or other humanized anti-B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
2. Has received prior treatment with an ADC that consists of an exatecan derivative (eg, trastuzumab deruxtecan).
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 complete pneumonectomy, or requirement for supplemental oxygen.

Study & Design

• Study Type: Interventional
• Study Design: Not specified