Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)
Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.
Timeline
- Start
- 2020-12-21
- Primary completion
- 2024-05-10
- Completion
- 2027-02-15
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper Dato-DXd significantly improved PFS versus docetaxel in patients with advanced/metastatic NSCLC, driven by patients with nonsquamous histology. reads as mixed primary results PMID 39250535 ↗
paper OS showed a numerical benefit but did not reach statistical significance. reads as mixed primary results PMID 39250535 ↗
release “TROPION-Lung01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival” reads as mixed primary results astrazeneca.com ↗
release “did not meet the prespecified threshold for statistical significance at this interim analysis.” reads as mixed primary results astrazeneca.com ↗
release “TROPION-Lung01 Phase III trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the primary endpoint of progression-free survival” reads as mixed primary results astrazeneca.com ↗
release “however, results did not reach statistical significance at the time of this data cut-off” reads as mixed primary results astrazeneca.com ↗
release “TROPION-Lung01 previously met the dual primary endpoint of progression-free survival in the overall trial population” reads as met primary endpoint astrazeneca.com ↗
release “TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival” reads as met primary endpoint astrazeneca.com ↗
Publications
- Sands J, Ahn MJ. Datopotamab deruxtecan versus docetaxel for non-small cell lung cancer: a plain language summary of the TROPION-Lung01 study. Future Oncol. 2026 Feb;22(3):271-284. doi: 10.1080/14796694.2025.2586004. Epub 2025 Nov 21.
- Ahn MJ, Lisberg A, Goto Y, Sands J, Hong MH, Paz-Ares L, Pons-Tostivint E, Perol M, Felip E, Sugawara S, Hayashi H, Cho BC, Blumenschein G Jr, Shum E, Lee JS, Heist RS, Cornelissen R, Chang WC, Kowalski D, Zebger-Gong H, Chargualaf M, Gu W, Lan L, Howarth P, Joseph R, Okamoto I. A Pooled Analysis of Datopotamab Deruxtecan in Patients With EGFR-Mutated NSCLC. J Thorac Oncol. 2025 Nov;20(11):1669-1682. doi: 10.1016/j.jtho.2025.06.002. Epub 2025 Jun 12.
- Ahn MJ, Tanaka K, Paz-Ares L, Cornelissen R, Girard N, Pons-Tostivint E, Vicente Baz D, Sugawara S, Cobo M, Perol M, Mascaux C, Poddubskaya E, Kitazono S, Hayashi H, Hong MH, Felip E, Hall R, Juan-Vidal O, Brungs D, Lu S, Garassino M, Chargualaf M, Zhang Y, Howarth P, Uema D, Lisberg A, Sands J; TROPION-Lung01 Trial Investigators. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. 2025 Jan 20;43(3):260-272. doi: 10.1200/JCO-24-01544. Epub 2024 Sep 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Datopotamab deruxtecan | Monoclonal antibody | 6 mg/kg | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |