Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma
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ClinicalTrials.gov Identifier: NCT01565538 |
Recruitment Status :
Completed
First Posted : March 28, 2012
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | Drug: Erlotinib Drug: Pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 123 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase II Trial of Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced EGFR Wild-Type and EGFR FISH-Positive Lung Adenocarcinoma |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Erlotinib
Erlotinib at the dose of 150 mg orally once a day continually until progression.
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Drug: Erlotinib
150 mg Given orally
Other Name: Tarceva |
Experimental: Pemetrexed
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
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Drug: Pemetrexed
500mg/m2 Given IV
Other Name: ALIMTA |
- Progression-Free Survival [ 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. ]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.
- Best Tumor Response [ Time Frame: From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization. ]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.
- Overall Survival [ Time Frame: From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization. ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565538
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 |
Principal Investigator: | Si-Yu Wang, Doctor | Sun Yat-sen University |
Responsible Party: | Si-Yu Wang, Professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT01565538 |
Other Study ID Numbers: |
wsy001 |
First Posted: | March 28, 2012 Key Record Dates |
Results First Posted: | September 15, 2014 |
Last Update Posted: | September 15, 2014 |
Last Verified: | September 2014 |
Cancer Non-small-cell lung cancer Adenocarcinoma EGFR gene mutation |
Chemotherapy Pemetrexed Erlotinib |
Adenocarcinoma Adenocarcinoma of Lung Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Erlotinib Hydrochloride Pemetrexed Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |