Carcinoma, Non-Small-Cell LungPhase 1/2NCT05460273

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)

A Phase 1/2 study testing Datopotamab Deruxtecan (Dato-DXd) in people with Carcinoma, Non-Small-Cell Lung and Triple Negative Breast Cancer, run by AstraZeneca at 21 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Cancer
What is being tested?: Datopotamab Deruxtecan (Dato-DXd)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 21 sitesChina
Study dates: 11 Jul 2022to 30 Jun 2027
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Additional Inclusion Criteria for Cohort 1 (NSCLC):
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.

Show all 16Show fewer

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.
Additional Inclusion Criteria for Cohort 2 (TNBC)
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.

Who cannot join

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.
Additional Exclusion Criteria for Cohort 1 (NSCLC):
Has mixed SCLC and NSCLC histology.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

China21 sites

Research Site
Beijing, 100039
Research Site
Beijing, 100044
Research Site
Beijing, 100142
Research Site
Bengbu, 233004
Research Site
Changchun, 130012
Research Site
Changchun, 130021
Research Site
Chengdu, 610000
Research Site
Chongqing, 400030
Research Site
Dalian, 116023
Research Site
Fuzhou, 350001
Research Site
Guangzhou, 510060
Research Site
Guangzhou, 510100
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Jinan, 250030
Research Site
Jinan, 250117
Research Site
Nanchang, 330006
Research Site
Nanchang, 330009
Research Site
Shenyang, 110042
Research Site
Wuhan, 430022
Research Site
Wuhan, 430030

Other trials in China

About this study

Official title: 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)

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.

Read the detailed description

This is a Phase 1/Phase 2, multicentre, open-label, multiple-cohort study, which is designed to evaluate the efficacy, safety, Pharmacokinetic, and immunogenicity of Dato-DXd in adult Chinese participants with advanced or metastatic solid tumours. It is a single-arm study with no blinding.

This study is divided into different cohorts. Participants of the same cohort are with the same tumour type. The starting cohorts are Cohort 1 (NSCLC) and Cohort 2 (TNBC). Future cohorts will consist of other advanced or metastatic solid tumour types, including, but not limited to, advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma or urothelial carcinoma that is refractory or intolerant to SoC therapy or for which no Standard of Care therapy is available.

Cohort 1 and Cohort 2 will be prioritised for immediate enrolment and the protocol will be amended as needed for the future cohorts.

Cohort 1: The target population of Cohort 1 is adult Chinese participants with advanced or metastatic NSCLC with or without actionable genomic alterations(AGAs) (ie, alterations in genes with approved therapies, such as EGFR, ALK, or other known AGAs).

Eligible participants without AGAs will have been previously treated with platinum-based chemotherapy and anti-PD-1/anti-PD-L1 monoclonal antibody either in combination or sequentially. Participants without AGAs who received anti-PD-1/anti-PD-L1 monoclonal antibody as frontline therapy may have received the combination of platinum-based chemotherapy and anti-PD-1/anti-PD-L1 monoclonal antibody in the second-line setting.

Eligible participants with AGAs will have been previously treated with one or two prior lines of applicable targeted therapy that is approved for the participant's genomic alteration and platinum-based chemotherapy as the only prior line of cytotoxic therapy. Participants with AGAs may have received up to one anti-PD-1/anti-PD-L1 monoclonal antibody treatment alone or in combination with chemotherapy.

A total of approximately 40 eligible participants in China will be enrolled in this cohort, including approximately 6 participants with AGAs.

Cohort 2: The target population of Cohort 2 is adult Chinese participants with inoperable locally advanced or metastatic TNBC who have received at least 2 prior chemotherapy regimens for advanced breast cancer, counting the (neo)adjuvant therapy as a prior chemotherapy regimen if progression occurred within 12 months after completion of the therapy (DFI ≤ 12 months).

A total of approximately 78 eligible participants in China will be enrolled in this cohort. Cohort 2 will enroll at most around 20% (approximately N=15) of enrolled participants with a DFI ≤ 12 months.

Enrolled participants will be treated with Dato-DXd at 6.0 mg/kg via an IV infusion on Day 1,every 3 weeks.

The primary objective of the study is to estimate the effectiveness of Dato-DXd by assessment of confirmed ORR by independent central review.

Conditions: Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Cancer
Being tested: Datopotamab Deruxtecan (Dato-DXd)
Keywords: Non-small-cell Lung Cancer, Triple-negative Breast Cancer, Dato-DXd, DS-1062a
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Datopotamab Deruxtecan (Dato-DXd)Drug
Also called DS-1062a
Dato-DXd is an antibody-drug conjugate (ADC) that binds to TROP2.

Study groups in NCT05460273
Study group	Role	What they receive
Dato-DXd Arm	Experimental	This single-arm study consists of multiple cohorts, divided by indication. Receives: Drug: Datopotamab Deruxtecan (Dato-DXd)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as determined by investigator assessment per RECIST 1.1.
Measured: 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
Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investgator, or death due to any cause.
Measured: 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
Disease control rate is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1, as assessed by ICR
Measured: 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
Best overall response is defined as participant's best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression.
Measured: 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
Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1
Measured: 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.
Progression-Free Survival (PFS) , Assessed by ICR
Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by ICR, or death due to any cause.
Measured: 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.
Overall Survival (OS)
Overall survival is defined as the time from the date of the first dose of study intervention to the date of death due to any cause.
Measured: 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.
Progression-Free Survival (PFS) , Assessed by Investigator
Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by investigator, or death due to any cause.
Measured: 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 Investigator
Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investigator, or death due to any cause.
Measured: 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 Investigator
Best overall response is defined as participant's best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression.
Measured: 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 Investigator
Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1.
Measured: 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.
Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ Total Anti-TROP2 Antibody
PK parameters of Total Anti-TROP2 Antibody_Area under the curve
Measured: 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.
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Total Anti-TROP2 Antibody
PK parameters of Total Anti-TROP2 Antibody_Maximum observed concentration
Measured: 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.
Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _Dato-DXd
PK parameters of Dato-DXd_Area under the curve
Measured: 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.
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Dato-DXd
PK parameters of Dato-DXd_Maximum observed concentration
Measured: 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.
Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ MAAA-1181a
PK parameters of MAAA-1181a_Area under the curve
Measured: 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.
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ MAAA-1181a
PK parameters of MAAA-1181a_Maximum observed concentration
Measured: 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.
Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Total Anti-TROP2 Antibody
PK parameters of Total Anti-TROP2 Antibody_Time to maximum plasma concentration
Measured: 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.
Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Dato-DXd
Time to maximum plasma concentration
Measured: 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.
Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _ MAAA-1181a
PK parameters of MAAA-1181a_Time to maximum plasma concentration
Measured: 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.
Immunogenicity of Dato-DXd
The prevalence of ADA (positive at any visit)
Measured: 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 ICR
Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by ICR, or death due to any cause.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 202230 Jun 2027

First posted15 Jul 2022
Study start11 Jul 2022
Primary completion7 Nov 2023
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is a Phase 1/Phase 2, multicentre, open-label, multiple-cohort study, which is designed to evaluate the efficacy, safety, PK, and immunogenicity of Dato-DXd in adult Chinese participants with advanced or metastatic solid tumours.
Masking: None (open label)
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05460273
Sponsor's protocol ID: D9266C00001
Status last verified: Aug 2026
First submitted: 8 Jun 2022
Last updated: 31 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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