Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

Si-Yu Wang123 enrolled

Overview

Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.

Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most patients. Second-line treatment options available to patients who suffer failure of first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival of NSCLC from EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive lung adenocarcinoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Lung Cancer

Interventions

ErlotinibDRUG

150 mg Given orally

PemetrexedDRUG

500mg/m2 Given IV

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically confirmed Lung adenocarcinoma * Wld-type EGFR * Stage IIIB/IV * Failure to prior chemotherapy * Life expectancy of more than 3 months * Tissue sample desired for genomic study * Age ≥ 18 years * Performance status (WHO) \< 3 * Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9gr/mm\^3) * Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl) * Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated * Informed consent Exclusion Criteria: * Have previously received pemetrexed or TKIs * Other concurrent uncontrolled illness

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Progression-Free Survival

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame: From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.

Secondary Outcomes

Best Tumor Response

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time frame: From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.

Overall Survival

Time frame: From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.

Data from ClinicalTrials.gov

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