OnCo
trialsTrialPositive

TROPION-Lung05

The study that got Datroway approved for EGFR-mutant lung cancer after other treatments fail.

137 patients (78 EGFR-mutant). ORR 35.8% overall, 43.6% in EGFR-mutant; median DOR 7.0 months. Pooled with TROPION-Lung01 EGFR-mutant patients (ORR 45%) to support accelerated approval in June 2025.

Setting
Actionable-genomic-alteration NSCLC after targeted therapy and platinum: datopotamab deruxtecan single arm
Phase
Phase 2
Sponsor
AstraZeneca / Daiichi Sankyo
Registry
Headline result
ORR 43.6% in EGFR-mutant disease.
Reported
2023
Enrolled
137
Replication
Single-arm phase 2 that supported the EGFR-mutant NSCLC approval; TROPION-Lung15 (randomised) will be the confirmatory trial.

Outcomes

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In plain words
What these results mean for people, not percentages
137 people took part
Objective response rate (BICR)primaryresponse endpoint
  • 35.8 vs 43.6 out of 100 had their tumour shrink with Datopotamab deruxtecan, all compared with EGFR-mutant subgroup; 7.8 fewer per 100.
  • On this measure the first group did worse, not better.
  • A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
  • These results apply to the people the trial enrolled: Actionable-genomic-alteration NSCLC after targeted therapy and platinum: datopotamab deruxtecan single arm. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

137 participants enrolled.

Objective response rate (BICR)primary
Datopotamab deruxtecan, all35.8 of 100
n = 137
EGFR-mutant subgroup43.6 of 100
n = 78
Source
EndpointArmnValueHR (95% CI)pSource
Objective response rate (BICR)primaryDatopotamab deruxtecan, all13735.8%link
EGFR-mutant subgroup7843.6%
Replication
Single-arm phase 2 that supported the EGFR-mutant NSCLC approval; TROPION-Lung15 (randomised) will be the confirmatory trial.

Connected

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