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Clinical Trials List

Protocol NumberDS7300-188
NCT Number(ClinicalTrials.gov Identfier)NCT06203210
Active

2024-05-21 - 2029-02-22

Phase III

Not yet recruiting1

Recruiting7

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 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)

  • Trial Applicant

     Daiichi Sankyo Taiwan Ltd. 

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/24

Investigators and Locations

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical 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 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 Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine
Taipei Medical University 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

Small Cell Lung Cancer

Objectives

In patients with relapsed SCLC, ifinatamab deruxtecan (I-DXd) treatment improved objective response rate (ORR) and prolonged overall survival compared to physician-selected therapy (TPC).

Test Drug

凍晶乾燥注射劑
凍晶乾燥注射劑
凍晶注射劑
注射用凍晶粉末

Active Ingredient

Ifinatamab Deruxtecan
1013011100
1013000310
TOPOTECAN HYDROCHLORIDE

Dosage Form

245
245
243
048

Dosage

100mg
4mg
1mg/ml

Endpoints

1. Comparison of the efficacy of I-DXd and TPC in patients with relapsed SCLC (based on ORR and OS as determined by BICR). ORR as determined by BICR is defined as the proportion of patients who achieved a CR or PR as confirmed by BICR according to RECIST v1.1.

[Approximately 5 years from baseline to patient disease progression, death, loss to follow-up, or withdrawal of consent.]

2. OS (Overall Survival)

[Approximately 5 years from randomization date to date of death from any cause.]

Inclution Criteria

Inclusion Criteria

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

Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
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.
Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
Has documentation of radiological disease progression on or after the most recent systemic therapy.
Has ECOG PS of ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1).
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.

Exclusion Criteria

Exclusion Criteria

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

Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (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.
Has received any of the comparators used in this study or any topoisomerase I inhibitor.
Has inadequate washout period before randomization as specified in the protocol.
Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
Has uncontrolled or significant cardiovascular disease.
Has clinically significant corneal disease.
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. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids.

Examples of suspected ILD/pneumonitis by imaging include the presence of lung parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE) and any radiographic features consistent with ILA, including but not limited to, extensive ground glass opacities, reticular opacities, traction bronchiectasis, and honeycombing.

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.

The Estimated Number of Participants

  • Taiwan

    27 participants

  • Global

    540 participants

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