Clinical Trials List
Protocol NumberDS7300-188
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
台灣第一三共股份有限公司
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chin-Wei Kuo Division of General Internal Medicine
- Wen-Pin Su Division of Hematology & Oncology
- 黃怡璇 Division of Hematology & Oncology
- 鍾秉軒 Division of Hematology & Oncology
- 蔡政軒 Division of General Internal Medicine
- Yu-Min Yeh Division of Hematology & Oncology
- Chien-Chung Lin Division of General Internal Medicine
- Shang-Yin Wu Division of Hematology & Oncology
- Seu-Chun Yang Division of General Internal Medicine
- Wu-Chou Su Division of Hematology & Oncology
- 黃怡菁 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu-Chao Lin Division of General Internal Medicine
- Chia-Hsiang Li Division of General Internal Medicine
- Chih-Yen Tu Division of Thoracic Medicine
- 陳鴻仁 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 趙恒勝 Division of Thoracic Medicine
- YEN-HAN TSENG Division of Thoracic Medicine
- 張毓帆 Division of Ophthalmology
- Yuh-Min Chen Division of Thoracic Medicine
- Yung-Hung Luo Division of Thoracic Medicine
- 廖映庭 Division of Thoracic Medicine
- 蕭慈慧 Division of Thoracic Medicine
- Chia-I Shen Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Inn-Wen Chong Division of Thoracic Medicine
- Chih-Jen Yang Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
- KUAN-LI WU Division of Thoracic Medicine
- 李玫萱 Division of Thoracic Medicine
- 郭家佑 Division of Thoracic Medicine
- 莊政皓 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳教恩 Division of Hematology & Oncology
- Chih-Hung Chen Division of Hematology & Oncology
- 林定佑 Division of Hematology & Oncology
- 柯皓文 Division of Hematology & Oncology
- Chih-Liang Wang Division of Hematology & Oncology
- 邱立忠 Division of Hematology & Oncology
- Chien-Ying Liu Division of Hematology & Oncology
- Ping-Chih Hsu Division of Hematology & Oncology
- 枋岳甫 Division of Hematology & Oncology
- 黃宗禎 Division of Hematology & Oncology
- Chih-Hsi Kuo Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Chi Lin Division of Hematology & Oncology
- 吳尚俊 Division of General Internal Medicine
- 廖斌志 Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
- 林宗哲 Division of Hematology & Oncology
- YEN-TING LIN Division of General Internal Medicine
- 黃得瑞 Division of Hematology & Oncology
- 郭柏邑 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Chao-Hua Chiu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- JENG-SEN TSENG Division of Thoracic Medicine
- KUO-HSUAN HSU Division of Thoracic Medicine
- YEN-HSIANG HUANG Division of Thoracic Medicine
- 李柏昕 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
SMALL CELL LUNG CANCER (SCLC)
Objectives
To compare the efficacy of I-DXd with
that of TPC, as measured by ORR per
BICR and OS, in subjects with relapsed
SCLC
Test Drug
injection
Active Ingredient
Ifinatamab Deruxtecan
Lurbinectedin
TOPOTECAN HYDROCHLORIDE
Lurbinectedin
TOPOTECAN HYDROCHLORIDE
Dosage Form
245
245
270
240
245
270
240
Dosage
100 mg
4 mg
1 mg/ml
4 mg
1 mg/ml
Endpoints
ORR per BICR is defined as the proportion of subjects with a
BOR of confirmed CR or confirmed PR per BICR according to
RECIST v1.1.
OS is defined as the time interval from the date of
randomization to the date of death due to any cause.
BOR of confirmed CR or confirmed PR per BICR according to
RECIST v1.1.
OS is defined as the time interval from the date of
randomization to the date of death due to any cause.
Inclution Criteria
1. Sign and date the informed consent form (ICF) 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 ICF 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. Required tumor tissue can be provided as one of the following:
a. If medically feasible, newly obtained pretreatment tumor biopsy from at least 1 lesion
amenable to biopsy.
b. If the tumor is inaccessible or the subject is medically unfit for collection of the
pretreatment tumor biopsy, archival tumor tissue collected from a biopsy performed
within 6 months of consent and performed after treatment with their most recent
anticancer therapy regimen.
c. If the newly obtained pretreatment biopsy is not feasible or the procedure is unsuccessful
and an appropriate archival sample (ie, collected within 6 months prior to study consent
and performed after treatment with their most recent anticancer therapy regimen) is not
available, an archival tumor biopsy from initial diagnosis.
If, after all efforts have been made, no qualifying tumor tissue is available, the subject may be
considered for study eligibility at the investigator’s discretion after discussion with the
Sponsor medical monitor.
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. Subjects with or
without prior immune-checkpoint inhibitor therapy are eligible. Subjects treated with a platinum-
based line of therapy for prior limited-stage-small cell lung cancer (LS-SCLC) may be eligible for
the study if the disease has progressed on treatment or within 6 months from platinum therapy
completion: the platinum-based line of therapy will count as 1L of therapy. If the investigator
believes a subject may benefit from platinum rechallenge, such subject may not participate in the
study. Subjects must not have received more than one prior line of systemic therapy. One line of
therapy will be defined as 1 or more drugs received prior to newly documented disease
progressions. Any switch between carboplatin and cisplatin for toxicity reasons will be regarded
as one line overall.
6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
Measurable lesions should not be from a previously irradiated site. If the lesion at a previously
irradiated site is the only selectable target lesion, a radiological assessment showing significant
progression of the irradiated lesion should be provided 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 before C1D1.
9. 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. Subjects with untreated brain
metastases will be allowed if they are asymptomatic, the investigator determines there is no
immediate CNS-specific treatment required, there is no significant surrounding edema, and the
procedures.
2. Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the ICF 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. Required tumor tissue can be provided as one of the following:
a. If medically feasible, newly obtained pretreatment tumor biopsy from at least 1 lesion
amenable to biopsy.
b. If the tumor is inaccessible or the subject is medically unfit for collection of the
pretreatment tumor biopsy, archival tumor tissue collected from a biopsy performed
within 6 months of consent and performed after treatment with their most recent
anticancer therapy regimen.
c. If the newly obtained pretreatment biopsy is not feasible or the procedure is unsuccessful
and an appropriate archival sample (ie, collected within 6 months prior to study consent
and performed after treatment with their most recent anticancer therapy regimen) is not
available, an archival tumor biopsy from initial diagnosis.
If, after all efforts have been made, no qualifying tumor tissue is available, the subject may be
considered for study eligibility at the investigator’s discretion after discussion with the
Sponsor medical monitor.
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. Subjects with or
without prior immune-checkpoint inhibitor therapy are eligible. Subjects treated with a platinum-
based line of therapy for prior limited-stage-small cell lung cancer (LS-SCLC) may be eligible for
the study if the disease has progressed on treatment or within 6 months from platinum therapy
completion: the platinum-based line of therapy will count as 1L of therapy. If the investigator
believes a subject may benefit from platinum rechallenge, such subject may not participate in the
study. Subjects must not have received more than one prior line of systemic therapy. One line of
therapy will be defined as 1 or more drugs received prior to newly documented disease
progressions. Any switch between carboplatin and cisplatin for toxicity reasons will be regarded
as one line overall.
6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
Measurable lesions should not be from a previously irradiated site. If the lesion at a previously
irradiated site is the only selectable target lesion, a radiological assessment showing significant
progression of the irradiated lesion should be provided 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 before C1D1.
9. 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. Subjects with untreated brain
metastases will be allowed if they are asymptomatic, the investigator determines there is no
immediate CNS-specific treatment required, there is no significant surrounding edema, and the
Exclusion 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 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. Subjects
who received any of the TPC options except for topotecan as 1L therapy may be eligible, provided
that a different TPC option from the one given as prior therapy is administered (TPC cannot be
repeated). The subject should not present any formal contraindication for the remaining TPC.
4. Has inadequate washout period before randomization, defined as follows:
a. Major surgery (placement of vascular access will not be regarded as a major surgery)
<4 weeks; surgery for low-invasive cases (eg, colostomy) <2 weeks.
b. Radiation therapy <4 weeks; palliative stereotactic radiation therapy without abdominal
radiation ≤2 weeks; radiation therapy to the lung >30 Gy <6 months; palliative
radiotherapy affecting lung areas at lower dose <3 weeks; cranial irradiation, including
whole brain radiation therapy and stereotactic radiosurgery ≤2 weeks.
c. Any systemic anticancer therapy (including immunotherapy [other than antibodies] and
investigational drugs) <3 weeks or 5 half-lives, whichever is longer; hormonal therapy
(except for luteinizing hormone-releasing hormone agonists/antagonists) <2 weeks.
d. Antibody-based anticancer therapy <3 weeks.
e. Chloroquine or hydroxychloroquine ≤14 days.
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, including the following:
a. Has a corrected QT interval (by Fridericia’s formula) >470 ms (females) or >450 ms
(males) based on average of the Screening triplicate 12-lead electrocardiogram.
b. Diagnosed or suspected long QT syndrome or known family history of long QT
syndrome.
c. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia,
ventricular fibrillation, or Torsade de Pointes.
d. Subject has bradycardia of less than 50 bpm unless the subject has a pacemaker.
targeted agents, including I-DXd.
2. Prior discontinuation of an 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. Subjects
who received any of the TPC options except for topotecan as 1L therapy may be eligible, provided
that a different TPC option from the one given as prior therapy is administered (TPC cannot be
repeated). The subject should not present any formal contraindication for the remaining TPC.
4. Has inadequate washout period before randomization, defined as follows:
a. Major surgery (placement of vascular access will not be regarded as a major surgery)
<4 weeks; surgery for low-invasive cases (eg, colostomy) <2 weeks.
b. Radiation therapy <4 weeks; palliative stereotactic radiation therapy without abdominal
radiation ≤2 weeks; radiation therapy to the lung >30 Gy <6 months; palliative
radiotherapy affecting lung areas at lower dose <3 weeks; cranial irradiation, including
whole brain radiation therapy and stereotactic radiosurgery ≤2 weeks.
c. Any systemic anticancer therapy (including immunotherapy [other than antibodies] and
investigational drugs) <3 weeks or 5 half-lives, whichever is longer; hormonal therapy
(except for luteinizing hormone-releasing hormone agonists/antagonists) <2 weeks.
d. Antibody-based anticancer therapy <3 weeks.
e. Chloroquine or hydroxychloroquine ≤14 days.
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, including the following:
a. Has a corrected QT interval (by Fridericia’s formula) >470 ms (females) or >450 ms
(males) based on average of the Screening triplicate 12-lead electrocardiogram.
b. Diagnosed or suspected long QT syndrome or known family history of long QT
syndrome.
c. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia,
ventricular fibrillation, or Torsade de Pointes.
d. Subject has bradycardia of less than 50 bpm unless the subject has a pacemaker.
The Estimated Number of Participants
-
Taiwan
27 participants
-
Global
540 participants
