A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03292133|
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : October 5, 2018
This research study is studying a combination of drugs as a possible treatment for EGFR mutation-positive lung cancer.
The drugs involved in this study are:
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: EGF816 Drug: Gefitinib||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease or patient population. "Investigational" means that the drug or drugs are being studied and have not been approved together for patients.
The FDA (the U.S. Food and Drug Administration) has approved gefitinib as a treatment option for EGFR mutation-positive lung cancer.
The FDA has not approved EGF816 as a treatment for any disease at this time.
In this research study, the investigators are studying the safety and efficacy of the combination of the study drugs EGF816 and gefitinib.
Both EGF816 and gefitinib are inhibitors which target a specific mutation in cancer and may stop tumors growing and multiplying.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer|
|Actual Study Start Date :||October 31, 2017|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2025|
Experimental: EGF816 + Gefitinib
EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
Other Name: Iressa
- Progression Free Survival at 9 months [ Time Frame: 9 months ]
The number of participants that are free from objective disease progression or death at 9 months. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
- Response Rate [ Time Frame: 2 years ]
The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
- Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
All CRs and PRs must be confirmed by a second assessment not earlier than 4 weeks after the criteria for response are first met.
- Overall Survival [ Time Frame: 2 years ]Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.
- Safety and Tolerability of the EGF816/gefitinib combination (Summary of the adverse events experienced by study participants as evaluated by CTCAE v4) [ Time Frame: 2 years ]Summary of the adverse events experienced by study participants as evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v4.
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): NCT03292133
|Contact: Beth Kennedy||617 724 1223||EAKENNEDY@mgh.harvard.edu|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02214|
|Contact: Beth Kennedy 617-724-1223 EAKENNEDY@mgh.harvard.edu|
|Principal Investigator: Zofia Piotrowska, MD|
|Principal Investigator:||Zofia Piotrowska, MD||Massachusetts General Hospital|