To Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation
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|ClinicalTrials.gov Identifier: NCT04132102|
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : October 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Squamous Cell Carcinoma||Drug: Afatinib||Phase 4|
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 EGFR sensitive mutation, and to explore the clinical factors which might be predictive for the effectiveness in LSQC.
Target patient population: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.
Investigational product, the dose and administration method: Afatinib is a member of the second generation TKIs, which binds irreversibly to the erbB family of receptors. Afatinib will be administrated orally with the starting dose of 40 mg tablets, once per day. If patients can't tolerate drug related AEs with 40mg, patients can receive 30mg once per day after AEs recovered to Grade 0-1 (CTCAE 5.0).
Study assessment: The collected data include the patient's demographic characteristics, information needed to determine whether the patient is eligible (including medical history, attributes of previous and current disease, and EGFR mutation status in tumor tissues), efficacy of objective response rate(ORR), progression-free survival (PFS), overall survival (OS), and safety (including serious adverse events and dose change-induced adverse events).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single-arm Clinical Study to Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation|
|Actual Study Start Date :||November 27, 2018|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: Afatinib treatment group
This is an open-label, sing-arm phase IV clinical study
Afatinib is a member of the second generation TKIs, which binds irreversibly to the erbB family of receptors. Afatinib will be administrated orally with the starting dose of 40 mg tablets, once per day. If patients can't tolerate drug related AEs with 40mg, patients can receive 30mg once per day after AEs recovered to Grade 0-1.
Other Name: GIOTRIF®
- Progression-free survival (PFS) [ Time Frame: Up to 12 months ]PFS refers to the time from initial prescription of afatinib to the time of disease progression or death recorded in CRF in this study, no matter whether the patient withdraw from the treatment before disease progression or receive other anti-cancer treatment or not. For the patient without progression or death at the time of analysis, the latest assessment date will be used as interpolation (censoring). (Or, if there's no tumor assessment after baseline visit, baseline visit date will be used
- Objective response rate (ORR) [ Time Frame: Up to 12 months ]ORR refers to the incidence of complete remission (CR) or partial remission (PR) (determined according to RECIST1.1 standards)
- Overall survival (OS) [ Time Frame: Up to 12 months ]OS refers to the time from the patient entering into the group to the time of death. When it comes to the analysis of patients with unknown survival status, the last date when learning of the patient's survival will be used as interpolation (censoring)
- Rate of SAEs, dose change-induced AEs, and AEs of particular concerns. [ Time Frame: Up to 12 months ]Serious adverse events [SAEs], dose change-induced AEs, and AEs of particular concerns.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132102
|Contact: Yongfeng Yu, Masterfirstname.lastname@example.org|
|Shanghai Chest Hospital||Recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: Yongfeng Yu, Master|
|Study Director:||Yongfeng Yu, Master||Shanghai Chest Hospital|