Erudio Healtherudio.com
Clinical trial · no report yet · Phase 1
NCT03260491
U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer
- NCT03260491 ↗
- Active, not recruiting
- Daiichi Sankyo
- Focused
We haven't built an HCP commentary report on NCT03260491 yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on NCT03260491 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer
- Phase
- Phase 1
- Status
- Active, not recruiting
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Interventions
- HER3-DXd (FL-DP); HER3-DXd (CTM-1 Lyo-DP); HER3-DXd (CTM-3 Lyo-DP)
- Arms
- Dose Escalation: Cohort 1, 3.2 mg/kg · Experimental
- Dose Escalation: Cohort 2, 4.8 mg/kg · Experimental
- Dose Escalation: Cohort 3, 5.6 mg/kg · Experimental
- Dose Escalation: Cohort 4, 6.4 mg/kg · Experimental
- Dose Expansion: Cohort 1, EGFR mutant · Experimental
- Dose Expansion: Cohort 2, EGFR wild-type · Experimental
- Dose Expansion: Cohort 3a, EGFR mutant · Experimental
- Dose Expansion: Cohort 3b, EGFR mutant · Experimental
- Dose Expansion: Cohort 4, EGFR mutant · Experimental
- Dose Expansion: Cohort 5, KRAS-G12C mutant NSCLC · Experimental
- Enrollment
- 312
- Primary outcomes
- Dose-limiting toxicities (DLTs) during dose escalation
- Summary of adverse events during dose escalation
- Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) Committee during dose expansion (Dose Expansion Cohorts 1, 2, 3a, 3b, and Cohort 5)
- Maximum serum concentration (Cmax) of HER3-DXd, total anti-HER3 antibody, and MAAA-1181a during dose expansion (Cohort 4)
- Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and up to last quantifiable time (AUC[last]) of HER3-DXd, total anti-HER3 antibody, and MAAA-1181a during dose expansion (Cohort 4)
- Sponsor
- Daiichi Sankyo with Merck Sharp & Dohme LLC
- Start
- Oct 30, 2017
- Primary completion
- Dec 1, 2025
- Results posted
- No
- Registry record
- NCT03260491 · updated Oct 26, 2026
Publications
linked from the registry- Jackman D, Pao W, Riely GJ, Engelman JA, Kris MG, Janne PA, Lynch T, Johnson BE, Miller VA. Clinical definition of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. J Clin Oncol. 2010 Jan 10;28(2):357-60. doi: 10.1200/JCO.2009.24.7049. Epub 2009 Nov 30. PubMed 19949011
- Steuer CE, Hayashi H, Su WC, Nishio M, Johnson ML, Kim DW, Massarelli E, Felip E, Gold KA, Murakami H, Baik CS, Kim SW, Smit EF, Fujimura M, Fan PD, Truchon K, Su X, Sternberg DW, Janne PA. Patritumab Deruxtecan (HER3-DXd; MK-1022) in Non-Small Cell Lung Cancer After Platinum-Based Chemotherapy and Immunotherapy. J Clin Oncol. 2025 Sep;43(25):2816-2826. doi: 10.1200/JCO-24-02744. Epub 2025 Jun 24. PubMed 40554742