A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
Recruiting
Phase 3
Interventional Study
Non-Small Cell Lung Cancer With HER2- Mutations
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
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About This Trial
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
Trial Locations
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Eligibility Criteria
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 …
Contacts