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

NCT02399566 | Unknown Phase 4

• 1 other identifier: CCTEBMTLA-2015
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Keywords

erlotinib; pemetrexed; maintenance therapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  two years

Secondary Outcomes (5)

• Overall survival (OS)

  two years

• Clinical benefit rate (CBR)

  two years

• Objective response rate (ORR)

  two years

• The adverse reaction

  two years

• Time to progression (TTP)

  two years

Study Arms (2)

Experimental

EXPERIMENTAL

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

Drug: Erlotinib, Pemetrexed

Comparator

ACTIVE COMPARATOR

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

Drug: Erlotinib, Pemetrexed

Interventions

Erlotinib, Pemetrexed DRUG

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

Comparator; Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Erlotinib Hydrochloride; Pemetrexed

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

JIANHUA CHEN, MD

CONTACT

0086-731-89762221; cjh_1000@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 22, 2015
• First Posted: March 26, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 26, 2015

Record last verified: 2015-03