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Clinical Trials List

Protocol NumberDS7300-127
NCT Number(ClinicalTrials.gov Identfier)NCT05280470

2022-06-01 - 2026-06-30

Phase II

Recruiting6

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/11/13

Investigators and Locations

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Lu Chiang Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳教恩 Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Extensive-stage Small-cell Lung Cancer

Objectives

This study aims to determine the recommended phase II dose of I-DXd based on the efficacy, safety, and pharmacokinetic (PK) results observed in treated extensive-stage small cell lung cancer (ES-SCLC) patients, and to investigate the antitumor activity of I-DXd in this population.

Test Drug

Ifinatamab Deruxtecan (I-DXd)

Active Ingredient

Ifinatamab Deruxtecan

Dosage Form

lyophilized powder for injection

Dosage

100 mg

Endpoints

1. Percentage of participants with treated small cell lung cancer (ES-SCLC) who received I-DXd therapy, based on blinded independent central review (BICR) objective response rate (ORR).

ORR is defined as the percentage of participants achieving the best overall response (BOR) among confirmed complete responses (CR) or partial responses (PR), assessed by BICR according to RECIST version 1.1. CR is defined as the disappearance of all target lesions, and PR is defined as a reduction of at least 30% in the total diameter of target lesions.

[Time range: up to approximately 24 months]

Inclution Criteria

Inclusion Criteria:

Participants must meet all the following criteria to be eligible for enrollment into the study:

Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures.
Participant must have at least one lesion, not previously irradiated, amenable to core biopsy.
Male or female subjects aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
Histologically or cytologically documented ES-SCLC.
At least one measurable lesion according to RECIST v1.1 as assessed by the investigator.
Prior therapy with at least one platinum-based line as systemic therapy for extensive-stage disease with at least two cycles of therapy (except in the case of early objective PD) and beginning with protocol version 3.0, a minimum of two previous lines of systemic therapy.
Documentation of radiological disease progression on or after most recent systemic therapy.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Exclusion Criteria

Exclusion Criteria:

Participants who meet any of the following criteria will be disqualified from entering the study:

Prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
Clinically active brain metastases, spinal cord compression or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
Any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
Clinically significant corneal disease.
Uncontrolled or significant cardiovascular disease.
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.
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses,
Chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/COPD) or topical steroids (for mild skin conditions) or intra-articular steroid injections.
History of malignancy other than SCLC within the 3 years prior to enrollment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal (GI) tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
History of allogeneic bone marrow, stem cell, or solid organ transplant.
Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0), Grade ≤1 or baseline.
History of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies.
Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
Has active or uncontrolled hepatitis B or C infection.
Active, known, or suspected autoimmune disease.
Any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses, psychiatric illness/social situations, substance abuse).
Has received a live vaccine within 30 days prior to the first dose of study drug.
Female who is pregnant or breast-feeding or intends to become pregnant during the study.
Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant.
Known human immunodeficiency virus (HIV) infection that is not well controlled.

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    150 participants

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