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 Zhang
Indication
NSCLC