A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)
Phase 1/2, Multicentre, Open-label, Multiple-cohort Study of Dato-DXd in Chinese Patients With Advanced Non-small-cell Lung Cancer, Triple-negative Breast Cancer, Gastric/Gastroesophageal Junction Cancer, Urothelial Cancer, and Other Solid Tumours (TROPION-PanTumor02)
1 other identifier
interventional
119
1 country
21
Brief Summary
Researchers are looking for a better way to treat advanced Triple-Negative Breast Cancer (TNBC) and Non-Small-Cell Lung Cancer (NSCLC). "Advanced" usually means that the cancer keeps growing even with treatment. The cancer may also be "metastatic", which means that it has spread to other parts of the body or the surrounding tissue. The study drug, Datopotamab deruxtecan, is designed to work by attaching to the tumor cells and stopping the tumor growth. Datopotamab deruxtecan is also known as Dato-DXd. In this study, the researchers want to find out how well Dato-DXd works to stop tumors from growing in Chinese participants with NCSLC or TNBC. This is the first time Dato-DXd is being studied in Chinese population. Participants in this study will get Dato-DXd through a needle as an injection. They will get 1 dose of Dato-DXd every 3 weeks until their cancer gets worse or they leave the study for another reason. Participants will visit their study sites at least once every 3 weeks for as long as they are in the study. The study doctors will take blood samples every 3 weeks and take images of the participants' tumors every 6 weeks until the participant leaves the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2022
Longer than P75 for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2022
CompletedStudy Start
First participant enrolled
July 11, 2022
CompletedFirst Posted
Study publicly available on registry
July 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2023
CompletedResults Posted
Study results publicly available
June 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedMarch 11, 2026
February 1, 2026
1.3 years
June 8, 2022
October 31, 2024
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Confirmed Objective Response Rate(ORR) Assessed by Independent Central Review(ICR)
Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as assessed by ICR per RECIST 1.1.
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
Secondary Outcomes (22)
Confirmed Objective Response Rate(ORR) Assessed by Investigator
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
Duration of Response (DoR), Assessed by Investigator
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
Disease Control Rate (DCR), Assessed by ICR
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
Best Overall Response (BoR) , Assessed by ICR
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
Time To Response (TTR) , Assessed by ICR
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
- +17 more secondary outcomes
Study Arms (1)
Dato-DXd Arm
EXPERIMENTALThis single-arm study consists of multiple cohorts, divided by indication.
Interventions
Dato-DXd is an antibody-drug conjugate (ADC) that binds to TROP2.
Eligibility Criteria
You may qualify if:
- Capable of giving signed informed consent.
- Participant must be ≥ 18 years at the time of screening.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- At least one lesion not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline and can be accurately measured at baseline and is suitable for accurate repeated measurements.
- \- Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease at the beginning of study intervention.
- For the subset of participants without AGAs:
- Documented negative test results for EGFR and ALK genomic alterations. If test results for EGFR and ALK are not available, participants are required to undergo testing performed locally for these genomic alterations.
- Participants must meet one of the required prior therapy requirements for advanced or metastatic NSCLC.
- For the subset of participants with AGAs:
- \- Documented positive test results for one or more actionable genomic alteration: EGFR, ALK, ROS1, METex14 skipping, RET or other AGAs with approved therapies
- \- Received one or two prior lines of applicable targeted therapy for the participant's genomic alteration at the time of screening.
- Pathologically documented oestrogen and progesterone receptor-negative and HER2-negative expression.
- Inoperable locally advanced or metastatic breast cancer.
- Received at least 2 prior chemotherapy regimens for locally advanced or metastatic breast cancer and previously treated with a taxane in any setting.
You may not qualify if:
- Has leptomeningeal carcinomatosis or metastasis
- Has clinically significant corneal disease
- Has known active hepatitis or uncontrolled hepatitis B or C infection
- Has a history of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Prior exposure to specific therapies without an adequate treatment washout period prior to enrolment.
- \- Has mixed SCLC and NSCLC histology.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyocollaborator
Study Sites (21)
Research Site
Beijing, 100039, China
Research Site
Beijing, 100044, China
Research Site
Beijing, 100142, China
Research Site
Bengbu, 233004, China
Research Site
Changchun, 130012, China
Research Site
Changchun, 130021, China
Research Site
Chengdu, 610000, China
Research Site
Chongqing, 400030, China
Research Site
Dalian, 116023, China
Research Site
Fuzhou, 350001, China
Research Site
Guangzhou, 510060, China
Research Site
Guangzhou, 510100, China
Research Site
Hangzhou, 310022, China
Research Site
Harbin, 150081, China
Research Site
Jinan, 250030, China
Research Site
Jinan, 250117, China
Research Site
Nanchang, 330006, China
Research Site
Nanchang, 330009, China
Research Site
Shenyang, 110042, China
Research Site
Wuhan, 430022, China
Research Site
Wuhan, 430030, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- It is a single-arm, multi-cohort study with no blinding.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2022
First Posted
July 15, 2022
Study Start
July 11, 2022
Primary Completion
November 7, 2023
Study Completion (Estimated)
June 30, 2026
Last Updated
March 11, 2026
Results First Posted
June 13, 2025
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.