Asset profile

Datopotamab Deruxtecan

Antibody–drug conjugate

Approvedregulatory verdict

Evidence outlook

Approved — HR+/HER2- Metastatic Breast Cancer, Non-Small Cell Lung Cancer

Regulatory approval supersedes design-level evidence grading — the trials behind approval are preserved below as the drug's evidence history.

How the evidence outlook works ↗

Upcoming events

(26 total)

Estimated primary-completion dates from ClinicalTrials.gov — registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
September 2026 (1)
Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2026-09-30 · NCT06417814 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2027 (6)
May 2027 (2)
Phase 1/2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-05-28 · NCT04644068 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-05-31 · NCT06974604 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

June 2027 (1)
Phase 3Non-Small Cell Lung CancerActive not recruiting
Est. primary completion 2027-06-30 · NCT06564844 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

July 2027 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-07-28 · NCT06103864 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

September 2027 (1)
Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-09-20 · NCT05629585 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

November 2027 (1)
Phase 3Non-Small Cell Lung CancerActive not recruiting
Est. primary completion 2027-11-01 · NCT05687266 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2028 (10)
January 2028 (2)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-01-01 · NCT06533826 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-01-01 · NCT06176261 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

February 2028 (2)
Phase 2Triple Negative Breast CancerRecruiting
Est. primary completion 2028-02 · NCT06954480 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-02-02 · NCT07205822 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

March 2028 (2)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-03-11 · NCT07471776 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-03-21 · NCT06350097 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

April 2028 (2)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-04 · NCT07535437 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2Non-Small Cell Lung CancerActive not recruiting
Est. primary completion 2028-04 · NCT04940325 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

June 2028 (1)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-06-30 · NCT06822543 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

November 2028 (1)
Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2028-11-20 · NCT06112379 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2029 (5)
January 2029 (1)
Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2029-01-29 · NCT07291037 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

April 2029 (1)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2029-04-06 · NCT07098338 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

May 2029 (1)
Phase 3Non-Small Cell Lung CancerActive not recruiting
Est. primary completion 2029-05-11 · NCT05555732 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

August 2029 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2029-08-01 · NCT07738341 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

December 2029 (1)
Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2029-12-28 · NCT06357533 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2030 (3)
March 2030 (1)
Phase 3Non-Small Cell Lung CancerActive not recruiting
Est. primary completion 2030-03-04 · NCT05215340 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

May 2030 (1)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2030-05-28 · NCT05061550 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

December 2030 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-12 · NCT01042379 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2031 (1)
November 2031 (1)
Phase 2Breast Cancer, Residual Disease, Triple Negative Breast Cancer (TNBC), Stage II/IIIRecruiting
Est. primary completion 2031-11-01 · NCT07069595 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

See the full readout calendar ↗

All registered studies

Research

Unlock the complete ClinicalTrials.gov registry

Research includes every linked study, indication filters, phase grouping and featured-trial cross-links.

Competitive landscape

Research

Unlock the competitor landscape

Research compares assets by shared mechanism and indication, including each competitor's stage in the relevant market.