Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug shows promise against tough cancers in first chinese trial

NCT ID NCT05460273

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This study tests a new drug called Dato-DXd in Chinese patients with advanced non-small-cell lung cancer or triple-negative breast cancer that has spread or stopped responding to treatment. The drug targets and kills cancer cells by attaching to them and blocking growth. About 119 participants will receive the drug every 3 weeks until their cancer worsens. The goal is to see how well it shrinks tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

119 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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. 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. Key Exclusion Criteria: * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Carcinoma, non-small-cell lung are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung Triple-negative breast cancer

Contacts and locations

Locations

  • 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.