Clinical trial · Interventional
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer
NCT06430437CI-TRIAL-00101285recruitingPhase 3ClinicalTrials.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)
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
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 |
|---|---|---|---|
| Non-Small Cell Lung Cancer With HER2- Mutations | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin | Drug | — | UNRESOLVED |
| SHR-A1811 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-A1811
- interventionNames
- Drug: SHR-A1811
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care（PD-1/ PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin）
- interventionNames
- Drug: PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin
Primary outcomes (1)
- measure
- Progression-free survival (PFS) based on blinded independent central review (BICR)
- timeFrame
- Until progression, assessed up to approximately 2 years
- description
- Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)
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. 18-75 years old (inclusive of both ends) 3. ECOG score of 0 or 1. 4. Patients with histologically or cytologically confirmed advanced or metastatic NSCLC. 5. Subjects with central laboratory- confirmed functional HER2 mutations 6. No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC. 7. Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1 8. Protocol-defined adequate organ function including cardiac, renal, hepatic function Exclusion Criteria: 1. Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology. 2. Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release. 3. Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis. 4. With poorly controlled tumor-related pain. 5. previous or current with other malignancies. 6. Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia. 7. Subjects with active or previous autoimmune diseases. 8. Subjects with uncontrolled or severe cardiovascular diseases. 9. Subjects with active hepatitis B or hepatitis C.
References
Publications (0)
Data not yet available
No reference posted for this study.