Back to results

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

Primary Purpose

Lung Adenocarcinoma

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Erlotinib, Pemetrexed

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma focused on measuring erlotinib, pemetrexed, maintenance therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression free survival (PFS)

Secondary Outcome Measures

Overall survival (OS)

Clinical benefit rate (CBR)

Objective response rate (ORR)

The adverse reaction

Time to progression (TTP)

Full Information

NCT ID

NCT02399566

First Posted

March 22, 2015

Last Updated

March 25, 2015

Sponsor

Hunan Province Tumor Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02399566

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

May 2015 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hunan Province Tumor Hospital

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Adenocarcinoma

Keywords

erlotinib, pemetrexed, maintenance therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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

Arm Title

Comparator

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Erlotinib, Pemetrexed

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression free survival (PFS)

Time Frame

two years

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Time Frame

two years

Title

Clinical benefit rate (CBR)

Time Frame

two years

Title

Objective response rate (ORR)

Time Frame

two years

Title

The adverse reaction

Time Frame

two years

Title

Time to progression (TTP)

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

JIANHUA CHEN, MD

Phone

0086-731-89762221

cjh_1000@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs