Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04132102
Other study ID # XK-LS-001
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 27, 2018
Est. completion date August 31, 2021

Study information

Verified date October 2019
Source Shanghai Chest Hospital
Contact Yongfeng Yu, Master
Phone 18017321559
Email yuyongfeng212@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 31, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Afatinib
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.

Locations

Country Name City State
China Shanghai Chest Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Objective response rate (ORR) ORR refers to the incidence of complete remission (CR) or partial remission (PR) (determined according to RECIST1.1 standards) Up to 12 months
Secondary 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) Up to 12 months
Secondary 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. Up to 12 months
See also
  Status Clinical Trial Phase
Withdrawn NCT04267913 - Testing of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel to the Usual Standard of Care for Advanced Squamous Cell Lung Cancer (A Lung-MAP Treatment Trial) Phase 2
Not yet recruiting NCT03725423 - Apatinib for Advanced Lung Squmamous Carcinoma Phase 4
Recruiting NCT06255197 - Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers
Active, not recruiting NCT04152018 - Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors. Phase 1
Recruiting NCT05778253 - The Role of ctDNA Testing Plus AI-based Pathology in Resectable LSCC
Recruiting NCT02876978 - Anti-GPC3 CAR T for Recurrent or Refractory Lung Squamous Cell Carcinoma Phase 1
Completed NCT01807546 - Oral Rigosertib for Squamous Cell Carcinoma Phase 2
Active, not recruiting NCT01386385 - Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery Phase 1/Phase 2
Active, not recruiting NCT00334815 - Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery Phase 2
Recruiting NCT05782764 - A Study of Endostar Combined With Chemotherapy and Immunotherapy in Lung Squamous Cell Carcinom Phase 4
Recruiting NCT05010330 - Identify Prognostic Biomarkers of Lung Cancer
Recruiting NCT06436040 - Mechanism Study to Investigate Difference in Efficacy of Neoadjuvant Chemoimmunotherapy in Lung Squamous Cell Carcinoma
Recruiting NCT05024266 - Tislelizumab Combined With Chemotherapy as Neoadjuvant Therapy for Stage IIIA-IIIB (N2) Lung Squamous Cell Carcinoma Phase 2
Recruiting NCT04802876 - Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors Phase 2