Status:
UNKNOWN
To Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Lung Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is an open-label, sing-arm, single site, phase IV clinical study. The main objective is to evaluate the efficacy of afatinib in LSQC patients with EGFR sensitive mutation, and to explore the clin...
Detailed Description
This is an open-label, sing-arm phase IV clinical study which will recruit about 20 patients in China. The main objective of this study is to evaluate the efficacy of afatinib in LSQC patients with E...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Selected patients must meet all of the following standards:
- The patient's or his/her legal representative's has signed and dated written informed consent before any specific study procedure.
- The patient is above 18 years old.
- Locally advanced (IIIB) or metastatic (stage IV) immunohistochemistry (IHC)-verified Lung squamous cell carcinoma (LSQC) with EGFR sensitive mutation patients, whom previously untreated or received platinum-based doublet chemotherapy as first-line treatment with subsequent disease progression, and had to be eligible for second-line treatment.
- The patient has NOT previously received EGFR-TKI treatment.
- ECOG Performance Status Score is 0\~2.
- The patient has sufficient bone marrow and organ function proved by baseline complete plasma count, plasma biochemistry and urinary biochemistry tests.
- Female patients of childbearing age must use adequate contraceptives, and breastfeeding is not allowed.
- Male patients must voluntarily to use contraceptives.
- Exclusion criteria
- Selected patients can not meet any one of the following standards:
- The patient has received EGFR-TKI treatment.
- The patient has any severe or uncontrolled systemic signs of illness, including uncontrolled hypertension, active easy-bleeding constitution, active infection, or significantly impaired function of bone marrow or organs, which researchers believe can significantly change the patient's risk/benefit balance.
- The patient has symptomatic central nervous system (CNS) metastases.
- The patient has the history of interstitial pneumonia, or radiation pneumonia which needs steroid treatment.
- The patient still has unrecovered toxic reaction with ≥ grade 3 (CTCAE5.0) caused by previously received treatment.
Exclusion
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04132102
Start Date
November 27 2018
End Date
August 31 2021
Last Update
October 29 2019
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030