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A multicenter study for pyrotinib maleate in the treatment of advanced non-small cell lung adenocarcinoma with HER2 mutation

A multicenter study for pyrotinib maleate in the treatment of advanced non-small cell lung adenocarcinoma with HER2 mutation

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800020262
Enrollment
Unknown
Registered
2018-12-21
Start date
2019-01-02
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged at least 18 years old; 2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-3; 3. Histologically or cytologic confirmed Non-small cell lung cancer, Phase IIIB or IV according to IASLC 2009; 4. Confirmed HER2 mutation by Central Laboratoryincluded PCRFISH, NGS; 5. At least one measurable lesion exists.(RECIST 1.1); 6. With no intervention in the study, patients may use pyrotinib in first or more lines; 7. Failed prior therapies.(RECIST 1.1); 8. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. There is a third interstitial fluid (such as a large amount of pleural effusion and ascites) that cannot be controlled by drainage or other methods, and the clinical treatment effect cannot be evaluated; 2. Radiotherapy, chemotherapy, surgery or other targeted therapy for non-small cell lung adenocarcinoma within 1 week prior to the study and did not progress from previous treatment; 3. The other conditions that patients are not eligible to enroll this observational study.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
ORR;DCR;OS;

Countries

China

Contacts

Public ContactYiping Zhang

Zhejiang Cancer Hospital

zjzlyy16@163.com+86 13750881678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026