Clinical trial
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
Name
POETHIS
Description
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
Trial arms
Trial start
2019-01-30
Estimated PCD
2023-12-30
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
PD-1 Combined With Pyrotinib
PD-1 Combined With Pyrotinib
Arms:
PD-1 Combined With Pyrotinib
Size
30
Primary endpoint
PFS
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-12-27
1 organization
1 product
1 indication
Organization
Yongchang ZhangProduct
PD-1 Combined With PyrotinibIndication
NSCLC