Chemotherapy Combined With Immunotherapy in HER 2 Insertion or Amplification Advanced NSCLC
Sponsor
Hunan Province Tumor Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04324125
Collaborator
(none)
70
1
48
1.5
Study Details
Study Description
Brief Summary
This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus PD-1 antibody in HER 2 insertion or amplification.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
Main enrolled criteria:
Her2 insertion advanced NSCLC Her 2 amplification advanced NSCLC Failed with standard chemotherapy No history of PD-1/ PD-L1 antibody using
Study Design
Study Type:
Observational
Anticipated Enrollment
:
70 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Chemotherapy or Chemotherapy Plus PD-1 Antibody in HER 2 Insertion or Amplification Advanced Non-small Cell Lung Cancer
Actual Study Start Date
:
Mar 24, 2020
Anticipated Primary Completion Date
:
Mar 24, 2023
Anticipated Study Completion Date
:
Mar 24, 2024
Outcome Measures
Primary Outcome Measures
- PFS [may 2020- may 2021 (1 year)]
Progression free survival
Secondary Outcome Measures
- OS [may 2020- may 2021 (1 year)]
Overall survival
- ORR [may 2020- may 2021 (1 year)]
To measure the patients's overall response rate
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
≥18,Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
-
HER 2 Insertion or Amplification
-
First Diagnosis and Treatment
-
Treatment Plan is Chemotherapy or Chemotherapy plus PD-1 antibody
Exclusion Criteria:
-
Patients received antitumor treatment before
-
Patients with contraindication of chemotherapy
-
Pregnant or breast feeding women
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Yongchang Zhang | Changsha | Hunan | China | 410013 |
Sponsors and Collaborators
- Hunan Province Tumor Hospital
Investigators
- Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Yongchang Zhang,
professor,
Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier:
NCT04324125
Other Study ID Numbers:
- CRONUS
First Posted:
Mar 27, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: