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Continued access to treatment for patients with advanced cancer

A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

Phase 3 Interventional Daiichi Sankyo · NCT06174987

This study is testing if patients with advanced cancer who have benefited from previous treatments can safely continue receiving a specific drug to see if it helps them longer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorDaiichi Sankyo Industry-sponsored
Locations28 sites (Miami, Florida and 27 other locations)
Trial IDNCT06174987 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter rollover study aims to provide ongoing treatment for participants who have shown clinical benefit from previous therapies sponsored by Daiichi Sankyo or AstraZeneca. The study includes various sub-protocols for different study drugs, focusing on the long-term safety and efficacy of T-DXd in patients with advanced or metastatic cancer. Participants must be currently enrolled in a parent study and demonstrate no evidence of disease progression to qualify for continued treatment.

Who should consider this trial

Good fit: Ideal candidates are patients currently enrolled in a Daiichi Sankyo or AstraZeneca-sponsored study who have shown clinical benefit and have no evidence of disease progression.

Not a fit: Patients who have unresolved adverse events or have been off T-DXd therapy for more than 18 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer patients with advanced cancer continued access to effective therapies, potentially improving their quality of life and treatment outcomes.

How similar studies have performed: Other studies involving continued access to therapies for advanced cancer patients have shown promise, indicating that this approach may be beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements.
* Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
* No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s).

Exclusion Criteria:

* Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria
* Participant who has been off T-DXd therapy for \>18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study

Where this trial is running

Miami, Florida and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced CancerMetastatic CancerAdvanced cancerMetastatic cancerT-DXdDS8201a
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.