Clinical Trial of Erlotinib and Pemetrexed for Maintenance Treatment in Lung Adenocarcinoma

Lung Adenocarcinoma Clinical Trial

Official title:

Comparative Clinical Trial of Erlotinib and Pemetrexed for Maintenance Treatment in Lung Adenocarcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02399566
• Other study ID #: CCTEBMTLA-2015
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 22, 2015
• Last updated: March 25, 2015
• Start date: May 2015
• Est. completion date: January 2019

Study information

• Verified date: March 2015
• Source: Hunan Province Tumor Hospital
• Contact: JIANHUA CHEN, MD
• Phone: 0086-731-89762221
• Email: cjh_1000[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare effects of erlotinib and pemetrexed as maintenance therapy for lung adenocarcinoma. Primary Outcome is the progression free survival (PFS). Based on prediction of different potential benefit groups, this study may help the oncologist to optimize and improve the maintenance therapy plan for lung adenocarcinoma.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically diagnosed stage III/IV Lung Adenocarcinoma;

• Age of 18-75years; Gender Not Required;

• Received systemic clinical examination, including chest X-ray, abdomen B ultrasound, head CT scan, radionuclide bone scan;

• Received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is SD or above SD (efficacy evaluation time is 21 days, if it is SD, then the longest diameter of target lesions shall not increase);

• Adequate hematologic, renal, and hepatic function, Specific index as follows: liver function: S-Bilirubin =1.5 ULN ; Transaminase=2 ULN. renal function: S-Creatinine =1.2 ULN; blood urea nitrogen =1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC=4.0×10^9/l, ANC=2.0×10^9/l platelet count =100×10^9/l, Hb=100 g/l;

• ECOG PS 0-2,Life expectancy = 3 months; endure more than two cycle chemotherapy;

• The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter = 10mm by spiral CT, MRI);

• No history of serious drug allergy;

• Informed consent should be obtained before treatment.

Exclusion Criteria:

• Not histologically or cytologically diagnosed as Lung Adenocarcinoma

• The age of >75 years or <18 years.

• Major organ dysfunction and Serious Heart Disease (congestive heart-failure, incontrollable high-risk arrhythmia, unstable angina, alular disease, myocardial infarct and Resistant hypertension,);

• Serious complications and investigator consider it is unsuited enrolling;

• Pregnant or lactating women;

• Allergic to research drug;

• Received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is PD

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Adenocarcinoma
• Lung Neoplasms

Intervention

Drug:
• Erlotinib, Pemetrexed
followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		two years	Yes
Secondary	Overall survival (OS)		two years	Yes
Secondary	Clinical benefit rate (CBR)		two years	Yes
Secondary	Objective response rate (ORR)		two years	Yes
Secondary	The adverse reaction		two years	Yes
Secondary	Time to progression (TTP)		two years	Yes