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Difficulty recruiting
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The purpose of this multicenter randomized study is to compare the effectiveness and safety of erlotinib and pemetrexed in the maintenance treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC)
A randomized multi-center prospective study to compare the 12-month effectiveness (survival) and safety of erlotinib and pemetrexed as maintenance treatment in two groups of patients with locally advanced or metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology, whose disease has not progressed immediately following platinum-based chemotherapy for 4 cycles administered per routine daily practice in each study center
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed Arm | Other | Vials containing powder for concentrate for solution for infusion equivalent to 500 mg of pemetrexed (as disodium) |
|
| Erlotinib Arm | Other | Film coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | Vials containing powder for concentrate for solution for infusion equivalent to 500 mg of pemetrexed (as disodium) administered as 500mg/m2 IV over 10 minutes on the first day of each 21-day cycle, until disease progression or unacceptable toxic effects |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) in eligible patients randomized to erlotinib or pemetrexed treatment arms | Progression Free Survival is defined as the time from date of randomization to the date of tumor progression or death from any cause, assessed until at least 12 months after randomization. Progression is defined using response evaluation criteria in solid tumors (RECIST version 1.1) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival (OS) Time between eligible patients randomized to erlotinib or pemetrexed treatment of therapy | Overall survival time is defined as the time from date of randomization until the date of death from any cause, assessed until at least 12 months after randomization | 12 months |
| Overall response rate and duration between eligible patients randomized to erlotinib or pemetrexed treatment arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Hussein Cancer Center (KHCC) | Amman | 11118 | Jordan | |||
| American University of Beirut Medical Center |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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Eligible patients will be randomized into either the arm of Erlotinib 150 mg once daily, or the arm of Pemetrexed 500 mg/m2 administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle, until disease progression or unacceptable toxic effects.
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|
| Erlotinib | Drug | Film coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride) administered once daily until disease progression or unacceptable toxic effects |
|
|
Overall response defined using RECIST version 1.1 and the duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started) or until at least 12 months after randomization as assessed every 6 weeks |
| 12 months |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) to erlotinib and pemetrexed | Incidence rates, severity, relationship of adverse events (AEs) and serious AE (SAE) to treatment drugs, number of AEs leading to permanent treatment discontinuation and clinically relevant changes in laboratory tests will be recorded, estimated and presented | 12 months |
| Beirut |
| 1107 2020 |
| Lebanon |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D011799 | Quinazolines |