Recruiting NCT04144569
PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PD-1 Combined With Pyrotinib.
- Who it may be relevant to
- Registry conditions: HER2 Insertion Mutation Positive Advanced NSCLC. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
the Effectiveness and Safety Study on PD-1 Combined With Pyrotinib for First-line Chemotherapy Failed HER2 Insertion Mutation Advanced Non-small Cell Lung Cancer
Overview
The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced Non-small Cell Lung Cancer
Interventions
- Drug PD-1 Combined With Pyrotinib
PD-1 Combined With Pyrotinib
Primary outcome measures
- PFS [Time frame: Approximately 1 years]
Secondary outcome measures (2)
- ORR [Time frame: Approximately 1 years]
- OS [Time frame: Approximately 1 years]
Eligibility criteria
Inclusion criteria
- Advanced non-small cell lung cancer confirmed by histology or cytology
- HER2 insertion mutation-positive
- Failure with first-line standard chemotherapy
- with measurable lesions.
Exclusion criteria
- no measurable tumor lesions
- Patients received PD-1 or Pyrotinib before
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Hunan Provincal Tumor Hospital — Changsha
Identifiers
NCT: NCT04144569 · POETHIS