Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations

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. Identifier: NCT00977470
Recruitment Status : Active, not recruiting
First Posted : September 15, 2009
Results First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Stanford University
Yale University
University of Maryland
Genentech, Inc.
Information provided by (Responsible Party):
Lecia V. Sequist, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Interventions: Drug: Erlotinib
Drug: Hydroxychloroquine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Erlotinib Erlotinib: 150 mg taken orally once daily
Erlotinib and Hydroxychloroquine

Erlotinib: 150 mg taken orally once daily

Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib

Participant Flow:   Overall Study
    Erlotinib   Erlotinib and Hydroxychloroquine
STARTED   38   38 
COMPLETED   0   0 
NOT COMPLETED   38   38 
Lack of Efficacy                32                30 
Physician Decision                2                0 
Adverse Event                1                2 
Protocol Violation                1                0 
Withdrawal by Subject                0                2 
Death                0                2 
clinical decline                0                1 
prolonged recovery post-surgery                0                1 
Still on-study                2                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.
No text entered.

Reporting Groups
Erlotinib Erlotinib: 150 mg taken orally once daily
Erlotinib and Hydroxychloroquine

Erlotinib: 150 mg taken orally once daily

Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib

Total Total of all reporting groups

Baseline Measures
   Erlotinib   Erlotinib and Hydroxychloroquine   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   38   76 
[Units: Years]
Median (Full Range)
 (43 to 84) 
 (37 to 82) 
 (37 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      24  63.2%      23  60.5%      47  61.8% 
Male      14  36.8%      15  39.5%      29  38.2% 
Smoking History 
[Units: Participants]
Count of Participants
Never smoked      28  73.7%      20  52.6%      48  63.2% 
<= 10 pack years      4  10.5%      8  21.1%      12  15.8% 
> 10 pack years/current      6  15.8%      10  26.3%      16  21.1% 
[Units: Participants]
Count of Participants
Adenocarcinoma      33  86.8%      31  81.6%      64  84.2% 
Non-small cell lung cancer, Not Otherwise Specifie      5  13.2%      7  18.4%      12  15.8% 
Brain metastases 
[Units: Participants]
Count of Participants
 11   16   27 
Prior chemotherapy 
[Units: Participants]
Count of Participants
 9   13   22 

  Outcome Measures

1.  Primary:   Median Progression Free Survival   [ Time Frame: From start of treatment until report of disease progression, assessed up to 10 years. ]

2.  Primary:   Nine-month Progression-free Survival Rate   [ Time Frame: Nine months ]

3.  Secondary:   Treatment Related Toxicity, > 10% Frequency, Any Grade   [ Time Frame: 2 years ]

4.  Secondary:   Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.   [ Time Frame: 2 years ]

5.  Other Pre-specified:   Circulating Tumor Cell Quantification   [ Time Frame: Until disease progression (median of 10.8 months) ]

6.  Other Pre-specified:   EGFR Mutational Status   [ Time Frame: 2 years ]

7.  Other Pre-specified:   Percent of Participants in Which FMISO-PET ([18F]-Fluoromisonidazole-positron Emission Tomography) is Able to Detect and Quantify Changes in Tumor Hypoxia After Erlotinib.   [ Time Frame: 12 weeks ]

8.  Secondary:   Overall Survival of Patients Treated With Erlotinib and With Erlotinib/HCQ   [ Time Frame: Until death ]
Results not yet reported.   Anticipated Reporting Date:   01/2018  

  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
No text entered.

  More Information

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

Results Point of Contact:  
Name/Title: Maria Kempner
Organization: Mass General Hospital Cancer Center
phone: 508-533-4132


Responsible Party: Lecia V. Sequist, Massachusetts General Hospital Identifier: NCT00977470     History of Changes
Other Study ID Numbers: 09-097
OSI4620s ( Other Identifier: OSI )
First Submitted: September 11, 2009
First Posted: September 15, 2009
Results First Submitted: March 22, 2017
Results First Posted: June 6, 2017
Last Update Posted: June 6, 2017