ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02399566
Recruitment Status : Not yet recruiting
First Posted : March 26, 2015
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Jianhua Chen, Hunan Province Tumor Hospital

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 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


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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399566


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

Sponsors and Collaborators
Hunan Province Tumor Hospital

Responsible Party: Jianhua Chen, MD, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT02399566     History of Changes
Other Study ID Numbers: CCTEBMTLA-2015
First Posted: March 26, 2015    Key Record Dates
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
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Pemetrexed
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors