Clinical trial · Interventional
A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer
Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation
NCT04818333CI-TRIAL-00077948unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification, or mutation
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A1811 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-A1811
- description
- SHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment
- interventionNames
- Drug: SHR-A1811
Primary outcomes (5)
- measure
- Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811
- timeFrame
- From Day 1 to90 days after last dose ，appropriately to 3 years
- description
- Assess safety and tolerability of SHR-A1811 by way of adverse events (CTCAE v5.0)
- measure
- Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811
- timeFrame
- From Day 1 to90 days after last dose ，appropriately to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. advanced non-small cell lung cancer with HER2 expression , amplification, or mutation 4. has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy. 5. There is at least one measurable lesion according to RECIST V1.1 criteria Exclusion Criteria: 1. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1. 2. Has received HER2 antibody drug conjugates, 3. Central nervous system metastasis or meningeal metastasis with clinical symptoms 4. Has active infection requiring systemic treatment.
References
Publications (2)
- DERIVEDLi Z, Wang Y, Sun Y, Wang L, Li X, Sun L, He Z, Yang H, Wang Y, Wang Q, Song Z, Hong W, Wang Y, Xia G, Yu Y, Peng M, Song Y, Wang D, Meng R, Fang J, Luo Y, Liang W, Hu S, Wang Z, Song K, Li Y, Yang L, Shi W, Lu S. Trastuzumab rezetecan, a HER2-directed antibody-drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study. Lancet Oncol. 2025 Apr;26(4):437-446. doi: 10.1016/S1470-2045(25)00012-9. Epub 2025 Feb 25. PMID 40020696
- DERIVEDLi Z, Song Z, Hong W, Yang N, Wang Y, Jian H, Liang Z, Hu S, Peng M, Yu Y, Wang Y, Jiao Z, Zhao K, Song K, Li Y, Shi W, Lu S. SHR-A1811 (antibody-drug conjugate) in advanced HER2-mutant non-small cell lung cancer: a multicenter, open-label, phase 1/2 study. Signal Transduct Target Ther. 2024 Jul 15;9(1):182. doi: 10.1038/s41392-024-01897-y. PMID 39004647