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Phase 2 Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR

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ClinicalTrials.gov Identifier: NCT01854034
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Lecia V. Sequist, Massachusetts General Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Intervention: Drug: AUY922

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AUY922 Treatment Arm AUY922 administered intravenously once a week at 70mg/m2

Participant Flow:   Overall Study
    AUY922 Treatment Arm
STARTED   29 
COMPLETED   29 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
AUY922 Treatment Arm AUY922 administered intravenously once a week at 70mg/m2

Baseline Measures
   AUY922 Treatment Arm 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Years]
Median (Full Range)
 
Participants Analyzed   29 
   60 
 (31 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   29 
Female      18  62.1% 
Male      11  37.9% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed   29 
United States   29 
Median Prior Lines of Therapy 
[Units: Therapies]
Median (Full Range)
 
Participants Analyzed   29 
   1 
 (1 to 5) 
Number of Participants with prior EGFR TKI [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   29 
   6 
[1] epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
Baseline ECOG PS [1] 
[Units: Participants]
Count of Participants
 
 
Participants Analyzed   29 
 9 
 
Participants Analyzed   29 
 18 
 
Participants Analyzed   29 
 2 
[1]

The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

  • 0: Asymptomatic (Fully active, able to carry on all pre-disease activities without restriction)
  • 1: Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
  • 2: Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)


  Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: From the start of treatment until the time of disease progression, median duration of follow-up of about 3 months ]

2.  Secondary:   Median Progression Free and Overall Survival   [ Time Frame: From the start of treatment until the time or death or disease progression ]

3.  Secondary:   The Number of Participants With Treatment Related Serious Adverse Events   [ Time Frame: From the start of treatment until 28 days after the end of treatment ]

4.  Secondary:   Exon 20 EGFR Mutations Among Participants That Responded to Treatment   [ Time Frame: Baseline, at the time of response ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lecia Van Dam Sequist, M.D.
Organization: Massachusetts General Hospital
phone: 617-724-4000
e-mail: lvsequist@partners.org



Responsible Party: Lecia V. Sequist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01854034     History of Changes
Other Study ID Numbers: 12-484
First Submitted: May 12, 2013
First Posted: May 15, 2013
Results First Submitted: February 8, 2018
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018