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

• ClinicalTrials.gov Identifier: NCT02399566
• Recruitment Status: Unknown
• First Posted: March 26, 2015
• Last Update Posted: March 26, 2015
• Sponsor: Hunan Province Tumor Hospital
• Information provided by (Responsible Party): Jianhua Chen, Hunan Province Tumor Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Adenocarcinoma	Drug: Erlotinib, Pemetrexed	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Clinical Trial of Erlotinib and Pemetrexed for Maintenance Treatment in Lung Adenocarcinoma
• Study Start Date: May 2015
• Estimated Primary Completion Date: January 2018
• Estimated Study Completion Date: January 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental; followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy	Drug: Erlotinib, Pemetrexed; followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy.
Active Comparator: Comparator; followed classical chemotherapy for 4 cycles, use Pemetrexed interventional for the maintenance therapy	Drug: Erlotinib, Pemetrexed; followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy.

Outcome Measures

Primary Outcome Measures :

1. Progression free survival (PFS) [ Time Frame: two years ]

Secondary Outcome Measures :

1. Overall survival (OS) [ Time Frame: two years ]
2. Clinical benefit rate (CBR) [ Time Frame: two years ]
3. Objective response rate (ORR) [ Time Frame: two years ]
4. The adverse reaction [ Time Frame: two years ]
5. Time to progression (TTP) [ Time Frame: two years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: JIANHUA CHEN, MD; 0086-731-89762221; cjh_1000@163.com

Sponsors and Collaborators

Hunan Province Tumor Hospital

More Information

• Responsible Party: Jianhua Chen, MD, Hunan Province Tumor Hospital
• ClinicalTrials.gov Identifier: NCT02399566
• Other Study ID Numbers: CCTEBMTLA-2015
• First Posted: March 26, 2015
• Last Update Posted: March 26, 2015
• Last Verified: March 2015

Keywords provided by Jianhua Chen, Hunan Province Tumor Hospital:

erlotinib; pemetrexed; maintenance therapy

Additional relevant MeSH terms:

Adenocarcinoma; Adenocarcinoma of Lung; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pemetrexed; Erlotinib Hydrochloride; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Protein Kinase Inhibitors