問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberDS1062-A-U104 (D926FC00001)
NCT Number(ClinicalTrials.gov Identfier)NCT04612751
Active

2023-02-01 - 2026-12-31

Phase I

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 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Immunotherapy With or Without Carboplatin in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04)

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 柯政昌 Division of Thoracic Medicine
National Taiwan University Hospital Hsin-Chu Branch

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 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 JIN-YUAN SHIH Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General 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 Chun-Hui Lee
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced or Metastatic NSCLC

Objectives

Primary: Evaluate the safety and tolerability of Dato-DXd (datopotamab deruxtecan) combined with immunotherapy, with or without up to 4 cycles of carboplatin treatment. Secondary: Evaluate the efficacy of Dato-DXd combined with immunotherapy, with or without up to 4 cycles of carboplatin treatment. Evaluate the pharmacokinetic (PK) profile of Dato-DXd, durvalumab, AZD2936, MEDI5752, and AZD7789, with or without up to 4 cycles of carboplatin treatment. Evaluate the immunogenicity of Dato-DXd, durvalumab, AZD2936, MEDI5752, and AZD7789, with or without up to 4 cycles of carboplatin treatment.

Test Drug

凍晶注射劑
注射劑
注射劑
注射劑
注射劑

Active Ingredient

datopotamab deruxtecan
IMFINZI
Rilvegostomig
Volrustomig
Sabestomig

Dosage Form

243
270
270
270
270

Dosage

100mg
50mg
250mg
250 mg
750mg

Endpoints

Evaluation of the safety and tolerability of Dato-DXd (datopotamab deruxtecan) in combination with immunotherapy, with or without up to 4 cycles of carboplatin treatment.

Outcome assessment method: Total number of participants experiencing DLT at each Dato-DXd dose level and treatment cycle; descriptive statistics of TEAEs and other safety endpoints.

Indicators: DLT, TEAE, SAE, AESI, ECOG PS, vital signs measurements, standard clinical laboratory parameters (hematology, clinical chemistry, and urinalysis), ECG parameters, ECHO/MUGA scan findings, and ophthalmic findings. AEs will be coded using the latest version of MedDRA. AEs and laboratory test results will be graded using NCI-CTCAE version 5.0.

Inclution Criteria

Inclusion Criteria:

Participant ≥18 years old on the day of signing the ICF (local regulatory requirement to consent should be followed).
Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC, without EGFR or ALK genomic alterations (testing not required for participants with documented squamous histology) and no known genomic alterations in other actionable driver kinases with approved therapies. Participants whose tumors harbor KRAS mutations are eligible for this study.
For Cohorts 1 to 4, participants must be treatment-naïve or have received and radiologically progressed after only 1 prior line of systemic chemotherapy, without concomitant immune checkpoint inhibitors for advanced or metastatic NSCLC. For Cohorts 4a, 5 to 11, and 14, participants must be treatment-naïve for advanced or metastatic NSCLC. For Cohorts 12 to 13, participants must be CPI acquired resistant after 1 or 2 prior lines of systemic therapy for advanced or metastatic NSCLC, of which 1 should have contained an approved anti-PD-1/PD L1. Cohort 4a will enroll participants whose tumors have squamous histology only; Cohorts 5 Part 2A and Part 2B as well as Cohorts 12 and 13 will enroll participants whose tumors have non-squamous histology only.
Willing and able to undergo a mandatory tumor biopsy. A tumor biopsy that was recently collected (within 3 months of screening) after completion of the most recent anticancer treatment regimen may be substituted for the biopsy collected during screening. For Cohorts 12 and 13, a tumor sample taken ≤24 months prior to screening is acceptable.
Has measurable disease per RECIST1.1 within 28 days prior to Cycle 1 Day 1
Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 at screening
Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 day 1
For Cohorts 5 to 14 only: Documented IHC PD-L1 expression per analytically validated Ventana PD-L1 (SP263) IHC assay, 22C3 PharmDx assay, or 28-8 PharmDx assay

Exclusion Criteria

Exclusion Criteria:

Active or prior documented autoimmune or inflammatory disorders
Uncontrolled or significant cardiac disease
History of another primary malignancy with exceptions
active or uncontrolled hepatitis B or C virus or uncontrolled HIV infection
spinal cord compression or clinically active CNS metastases
History of (non-infectious) ILD/pneumonitis that required steroids
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illness
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
Clinically significant corneal disease

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    371 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB