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To Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation

Primary Purpose

Lung Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Afatinib
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Squamous Cell Carcinoma focused on measuring LSQC, EGFR mutation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Selected patients must meet all of the following standards:

    1. The patient's or his/her legal representative's has signed and dated written informed consent before any specific study procedure.
    2. The patient is above 18 years old.
    3. 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.
    4. The patient has NOT previously received EGFR-TKI treatment.
    5. ECOG Performance Status Score is 0~2.
    6. The patient has sufficient bone marrow and organ function proved by baseline complete plasma count, plasma biochemistry and urinary biochemistry tests.
    7. Female patients of childbearing age must use adequate contraceptives, and breastfeeding is not allowed.

    8. Male patients must voluntarily to use contraceptives.

      Exclusion criteria

  • Selected patients can not meet any one of the following standards:

    1. The patient has received EGFR-TKI treatment.
    2. 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.
    3. The patient has symptomatic central nervous system (CNS) metastases.
    4. The patient has the history of interstitial pneumonia, or radiation pneumonia which needs steroid treatment.
    5. The patient still has unrecovered toxic reaction with ≥ grade 3 (CTCAE5.0) caused by previously received treatment.

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Afatinib treatment group

Arm Description

This is an open-label, sing-arm phase IV clinical study

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
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

Secondary Outcome Measures

Objective response rate (ORR)
ORR refers to the incidence of complete remission (CR) or partial remission (PR) (determined according to RECIST1.1 standards)
Overall survival (OS)
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.
Serious adverse events [SAEs], dose change-induced AEs, and AEs of particular concerns.

Full Information

First Posted
November 27, 2018
Last Updated
October 25, 2019
Sponsor
Shanghai Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04132102
Brief Title
To Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 clinical factors which might be predictive for the effectiveness in LSQC.
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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Squamous Cell Carcinoma
Keywords
LSQC, EGFR mutation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Afatinib treatment group
Arm Type
Experimental
Arm Description
This is an open-label, sing-arm phase IV clinical study
Intervention Type
Drug
Intervention Name(s)
Afatinib
Other Intervention Name(s)
GIOTRIF®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR refers to the incidence of complete remission (CR) or partial remission (PR) (determined according to RECIST1.1 standards)
Time Frame
Up to 12 months
Title
Overall survival (OS)
Description
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)
Time Frame
Up to 12 months
Title
Rate of SAEs, dose change-induced AEs, and AEs of particular concerns.
Description
Serious adverse events [SAEs], dose change-induced AEs, and AEs of particular concerns.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongfeng Yu, Master
Phone
18017321559
Email
yuyongfeng212@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongfeng Yu, Master
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongfeng Yu, Master

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation

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