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

NCT ID: NCT02399566

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-01-31

Brief 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.

Conditions

Lung Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental

followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy

Group Type: EXPERIMENTAL

Erlotinib, Pemetrexed

Intervention Type: DRUG

followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy.

Comparator

followed classical chemotherapy for 4 cycles, use Pemetrexed interventional for the maintenance therapy

Group Type: ACTIVE_COMPARATOR

Erlotinib, Pemetrexed

Intervention Type: DRUG

followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy.

Interventions

Erlotinib, Pemetrexed

followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Province Tumor Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jianhua Chen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

JIANHUA CHEN, MD

Role: CONTACT

cjh_1000@163.com

0086-731-89762221

Other Identifiers

CCTEBMTLA-2015

Identifier Type: -

Identifier Source: org_study_id