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Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in Ⅲb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

Primary Purpose

Lung, Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Erlotinib

About this trial

This is an interventional treatment trial for Lung, Carcinoma focused on measuring chemotherapy, maintenance therapy, erlotinib

Eligibility Criteria

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

Inclusion Criteria:

Patients between 18 and 75 years of age.
Present with histologically proven or cytological diagnosis of non-Squamous NSCLC Stage IIIB or IV as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy,such as surgery or radiotherapy and so on.
No prior systemic chemotherapy or targeted therapy for lung cancer before screening.
Confirmed activating mutation of EGFR-ie, an exon 19 deletion or an exon 21 L858R point mutation.
Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1.
Adequate organ function.
Prior radiation therapy allowed to <25% of the bone marrow . Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
Signed informed consent document on file.
Estimated life expectancy of ≥12 weeks.
Patient compliance and geographic proximity that allow adequate follow up.

Exclusion Criteria:

Known severe hypersensitivity to erlotinib.
Patients with uncontrolled brain metastasis.
Pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures.
Inability to comply with protocol or study procedures.
A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
Interstitial pneumonia.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Pemetrexed 500mg/m2+Carboplatin area under curve(AUC)=5, every 3 weeks, maximum 4 cycles, Erlotinib 150mg/d every cycle d2-15, and Erlotinib 150mg/d from the last cycle until disease progression

Outcomes

Primary Outcome Measures

Response Evaluation Criteria in Solid Tumors(RECIST) 1.1

Patients were imaged with computed tomography (CT) scan

Secondary Outcome Measures

Full Information

NCT ID

NCT02066038

First Posted

February 16, 2014

Last Updated

February 16, 2014

Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT02066038

Brief Title

Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in Ⅲb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

Official Title

A Multi-center, Open-labeled Phase 2 Study of First Line Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in ⅢB/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, has been recommended as the first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients' progression-free survival. The OPTIMAl trial indicated that those who received TKI and chemotherapy during the whole treatment window survived longest. Unfortunately, previous studies(INTACT, TRIBUTE et al) that concurrently combined TKI and cytotoxic regimens failed to improve survival in unselected patients. To avoid the potential synergistic antagonism, the FAST-ACT II trial committed a sequential strategy and find a superiority in the combination arm upon chemotherapy even in EGFR-mutated group. However, pharmaceutically, the continuous administration of an EGFR-TKI before subsequent chemotherapy in FAST-ACT II could obviate the effects of cytotoxic agents due to the erlotinib-induced G1 arrest. On the basis of these and other studies, the investigators hypothesized that a better sequential combination strategy of EGFR-TKI and chemotherapy (adding a EGFR-TKI wash-out window before chemotherapy) would be more efficacious than chemotherapy alone. In this study, the investigators investigate the efficacy(PFS:progression free survival), safety, and adverse-event profile of chemotherapy plus intermittent and maintenance of erlotinib, when these drugs were used as first-line treatment in who had non-squamous lung carcinoma with EGFR gene mutation in China.

6. Conditions and Keywords

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

Lung, Carcinoma

Keywords

chemotherapy, maintenance therapy, erlotinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Pemetrexed 500mg/m2+Carboplatin area under curve(AUC)=5, every 3 weeks, maximum 4 cycles, Erlotinib 150mg/d every cycle d2-15, and Erlotinib 150mg/d from the last cycle until disease progression

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Other Intervention Name(s)

Tarceva

Intervention Description

150mg po on days 2-15 of each 3 week cycle for 4 cycles and 150mg po per day after 4 cycles until disease progression

Primary Outcome Measure Information:

Title

Response Evaluation Criteria in Solid Tumors(RECIST) 1.1

Description

Patients were imaged with computed tomography (CT) scan

Time Frame

eight weeks

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: Patients between 18 and 75 years of age. Present with histologically proven or cytological diagnosis of non-Squamous NSCLC Stage IIIB or IV as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy,such as surgery or radiotherapy and so on. No prior systemic chemotherapy or targeted therapy for lung cancer before screening. Confirmed activating mutation of EGFR-ie, an exon 19 deletion or an exon 21 L858R point mutation. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1. Adequate organ function. Prior radiation therapy allowed to <25% of the bone marrow . Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. Signed informed consent document on file. Estimated life expectancy of ≥12 weeks. Patient compliance and geographic proximity that allow adequate follow up. Exclusion Criteria: Known severe hypersensitivity to erlotinib. Patients with uncontrolled brain metastasis. Pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures. Inability to comply with protocol or study procedures. A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study. A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. Interstitial pneumonia.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hao Long, Prof

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in Ⅲb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

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