Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03054038|
Recruitment Status : Suspended (Pause for COVID-19 Response)
First Posted : February 15, 2017
Last Update Posted : May 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Carcinoma||Drug: Afatinib Biological: Necitumumab Other: Laboratory Biomarker Analysis||Phase 1|
I. To determine the maximum tolerated dose of combination afatinib and necitumumab therapy in EGFR mutation positive non-small cell lung cancer (NSCLC) patients who have progressed following first- and third-generation EGFR tyrosine kinase inhibitors (TKIs).
II. To determine the efficacy and safety profile of afatinib and necitumumab combination therapy in patients with EGFR mutation positive NSCLC patients who have progressed following first- and third-generation EGFR TKIs.
OUTLINE: This is a dose-escalation study.
Patients receive afatinib orally (PO) once daily (QD) on days 1-28 and necitumumab intravenously (IV) over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days and then every 3 months for up to 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Combination Afatinib and Necitumumab in EGFR Mutation Positive NSCLC With Acquired Resistance to First or Third Generation EGFR TKIs|
|Actual Study Start Date :||July 20, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Patients receive afatinib PO QD on days 1-28 and necitumumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Given by mouth
Other: Laboratory Biomarker Analysis
- Maximum tolerated dose experience a dose-limiting toxicity [ Time Frame: Up to 28 days ]Highest dosage at which 0 or 1/6 patients
- Objective response rate [ Time Frame: Up to one year ]Complete response assessed by RECIST version (v) 1.1
- Objective response rate [ Time Frame: Up to one year ]Partial response assessed by RECIST version (v) 1.1
- Overall survival [ Time Frame: From the first dose of study treatment to the time of death from any cause on study, assessed up to 1 year ]Assessed by RECIST v1.1
- Duration of response [ Time Frame: Up to 1 year ]Assessed by RECIST v1.1
- Incidence of adverse events [ Time Frame: Up to 1 year ]Assessed by NCI CTCAE
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): NCT03054038
|United States, California|
|City of Hope National Medical Center|
|Duarte, California, United States, 91010|
|Stanford Cancer Institute|
|Stanford, California, United States, 94035|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Leora Horn, M.D.||Vanderbilt-Ingram Cancer Center|