Overview

This trial is active, not recruiting.

Condition lung, carcinoma
Treatment erlotinib
Phase phase 2
Target EGFR
Sponsor Sun Yat-sen University
Collaborator First Affiliated Hospital, Sun Yat-Sen University
Start date January 2014
End date April 2015
Trial size 60 participants
Trial identifier NCT02066038, 2013-FXY-025

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
erlotinib Tarceva
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 Outcomes

Measure
Response Evaluation Criteria in Solid Tumors(RECIST) 1.1
time frame: eight weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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
Principal investigator Hao Long, Prof
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.