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

Tracking Information

• First Submitted Date: March 22, 2015
• First Posted Date: March 26, 2015
• Last Update Posted Date: March 26, 2015
• Study Start Date: May 2015
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 25, 2015): Progression free survival (PFS) [ Time Frame: two years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 25, 2015)

• Overall survival (OS) [ Time Frame: two years ]
• Clinical benefit rate (CBR) [ Time Frame: two years ]
• Objective response rate (ORR) [ Time Frame: two years ]
• The adverse reaction [ Time Frame: two years ]
• Time to progression (TTP) [ Time Frame: two years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Trial of Erlotinib and Pemetrexed for Maintenance Treatment in Lung Adenocarcinoma
• Official Title: Comparative Clinical Trial of Erlotinib and Pemetrexed for Maintenance Treatment in Lung Adenocarcinoma
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Lung Adenocarcinoma

Intervention

Drug: Erlotinib, Pemetrexed

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

Study Arms

• Experimental: Experimental
  followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy
  Intervention: Drug: Erlotinib, Pemetrexed
• Active Comparator: Comparator
  followed classical chemotherapy for 4 cycles, use Pemetrexed interventional for the maintenance therapy
  Intervention: Drug: Erlotinib, Pemetrexed

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 25, 2015): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2019
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02399566
• Other Study ID Numbers: CCTEBMTLA-2015
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jianhua Chen, Hunan Province Tumor Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Hunan Province Tumor Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hunan Province Tumor Hospital
• Verification Date: March 2015