Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant 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: NCT03810807|
Recruitment Status : Active, not recruiting
First Posted : January 22, 2019
Last Update Posted : February 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Non-small Cell Lung Cancer||Drug: Dacomitinib Drug: Osimertinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Combination Dacomitinib and Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers|
|Actual Study Start Date :||January 17, 2019|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Experimental: Dacomitinib and Osimertinib
Patients will begin on combination dacomitinib and osimertinib at the prescribed doses.
A cycle will be 28 days in duration. The study will use a standard 3+3 dose escalation design.
Dose level 1 Dacomitinib, Dose level 2 Dacomitinib, Dose level 3 Dacomitinib. Three patients will need to be enrolled at each dose level and assessed for DLT for 1 full cycle (28 days for cycle 1) before dose escalation decision is made.
Dose level 1, 2 and 3 Osimertinib 40mg daily. Three patients will need to be enrolled at each dose level and assessed for DLT for 1 full cycle (28 days for cycle 1) before dose escalation decision is made.
- maximum tolerated dose [ Time Frame: 1 year ]The MTD will be defined as the highest dose at which not more than 1/6 of the patients experience dose limiting toxicity (DLT). DLT is defined as any of the toxicity events described below that occurs within cycle 1 of treatment with the combination of dacomitinib and osimertinib.
- Best overall response rate [ Time Frame: 1 year ]Tumor response will be assessed using RECIST 1.1.The NCI Common Terminology Criteria for Adverse Events Version 5 (NCI-CTCAE) will be used to grade toxicities during the trial. Dose-limiting toxicities (DLT"s) are defined as any of the following events occurring during the first cycle of treatment
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): NCT03810807
|United States, New Jersey|
|Memoral Sloan Kettering Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|Memorial Sloan Kettering Monmouth|
|Middletown, New Jersey, United States, 07748|
|Memorial Sloan Kettering Bergen|
|Montvale, New Jersey, United States, 07645|
|United States, New York|
|Memorial Sloan Kettering Commack|
|Commack, New York, United States, 11725|
|Memoral Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering Nassau|
|Uniondale, New York, United States, 11553|
|Principal Investigator:||Helena Yu, MD||Memorial Sloan Kettering Cancer Center|