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

NCT04132102 | Unknown Phase 4

• 1 other identifier: XK-LS-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Squamous Cell Carcinoma

Keywords

LSQC; EGFR mutation

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 12 months

Secondary Outcomes (3)

• Objective response rate (ORR)

  Up to 12 months

• Overall survival (OS)

  Up to 12 months

• Rate of SAEs, dose change-induced AEs, and AEs of particular concerns.

  Up to 12 months

Study Arms (1)

Afatinib treatment group

EXPERIMENTAL

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

Drug: Afatinib

Interventions

Afatinib DRUG

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.

Also known as: GIOTRIF®

Afatinib treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Interventions

Afatinib

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yongfeng Yu, Master

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Yongfeng Yu, Master

CONTACT

18017321559; yuyongfeng212@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: October 18, 2019
• Study Start: November 27, 2018
• Primary Completion: April 30, 2021
• Study Completion: August 31, 2021
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

CN (1)