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
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Erlotinib Drug: Pemetrexed||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2013|
U.S. FDA Resources
Erlotinib at the dose of 150 mg orally once a day continually until progression.
150 mg Given orally
Other Name: Tarceva
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
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. ]
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
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Si-Yu Wang, Doctor||Sun Yat-sen University|