EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

Nonsmall Cell Lung Cancer Clinical Trial

Official title:

EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03002844
• Other study ID #: ShanghaiPH002
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 14, 2016
• Last updated: December 25, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2016
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Caicun Zhou, MD PHD
• Phone: 8613301825532
• Email: caicunzhoudr[@]163.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial Summary

BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Description:

BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent

2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)

3. Must have measurable or non-measurable disease

4. Must be able to comply with study and follow-up procedures

Exclusion Criteria:

1. Small cell, carcinoid, or mixed small cell lung cancer

2. Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer

3. Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC

4. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication

5. History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications

6. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption

7. Pregnancy or lactation

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Gene Mutation
• Nonsmall Cell Lung Cancer

Intervention

Drug:
• EGFR-TK Inhibitor
EGFR-TKI (gefitinib 250mg per day)
• EGFR-TKI
EGFR-TKI (gefitinib 250mg per day)
• EGFR-TKI and Chemotherapy
pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress Free Survival		up to 12 months	Yes
Secondary	Overall Survival		up to 24 months	Yes
Secondary	Overall Response Rate		up to 12 months	Yes
Secondary	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Safety	up to 12 months	Yes