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The study that got Datroway approved for EGFR-mutant lung cancer after other treatments fail.
TROPION-Lung05, trial NCT04484142 sponsored by AstraZeneca and Daiichi Sankyo and reported in 2023, is the phase 2 study that supported approval of datopotamab deruxtecan for EGFR-mutant non-small-cell lung cancer after targeted therapy and platinum chemotherapy have failed. It enrolled 137 patients with actionable genomic alterations in a single-arm design, the objective response rate by blinded review was higher in the 78 EGFR-mutant patients than overall, and pooled with EGFR-mutant patients from TROPION-Lung01 the data supported accelerated approval in June 2025. OnCo links it to TROP2 and EGFR as targets and to TROPION-Lung01. As a single-arm phase 2 it cannot show that the drug improves survival over the alternatives, and the randomised TROPION-Lung15 trial will be the confirmatory study. Datopotamab deruxtecan has its own page.
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 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate (BICR)primary | Datopotamab deruxtecan, all | 137 | 35.8% | - | - | link |
| EGFR-mutant subgroup | 78 | 43.6% |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Datopotamab deruxtecan, Daiichi Sankyo, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Datopotamab deruxtecan, TROP2, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Datopotamab deruxtecan, TROP2, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Datopotamab deruxtecan, Daiichi Sankyo, TROP2, Topoisomerase-I inhibitors (and ADC payloads).
Shares Datopotamab deruxtecan, TROP2, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Datopotamab deruxtecan, TROP2, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Datopotamab deruxtecan, TROP2, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Datopotamab deruxtecan, Daiichi Sankyo, TROP2, Non-small-cell lung cancer.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/