Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03891615|
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : December 16, 2020
This research study is studying a combination of drugs as a possible treatment for EGFR-Mutated Advanced Lung Cancer.
The names of the study drugs involved in this study are Niraparib and Osimertinib.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Niraparib Drug: Osimertinib||Phase 1|
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved niraparib for this specific disease but it has been approved for other uses.
The FDA has approved osimertinib as a treatment option for this disease.
Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells through deadly DNA damage. PARP inhibition may be a treatment option for participants with this type of cancer due to altered repair and protection of tumor DNA.
Osimertinib is an inhibitor of the epidermal growth factor receptor (EGFR). In this type of cancer there is a mutation in the EGFR which is allowing the cancer to grow when it is not supposed to. Osimertinib blocks mutated EGFR, which may cause tumor regression (when the tumor starts to shrink) and prevent the spread of the cancer.
In this research study, the investigators are looking to see whether the combination of niraparib and osimertinib is safe and well tolerated and what the best dose of niraparib is in participants with EGFR-Mutated Advanced Lung Cancer. The investigators also hope that the combination of niraparib and osimertinib will stop the cancer from growing and spreading.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer|
|Actual Study Start Date :||June 6, 2019|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||April 30, 2024|
Experimental: Niraparib + Osimertinib
Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells through deadly DNA damage.
Other Name: ZEJULA
Osimertinib blocks mutated EGFR, which may cause tumor regression (when the tumor starts to shrink) and prevent the spread of the cancer.
Other Name: Tagrisso
- Maximum Tolerated Dose of Niraparib [ Time Frame: 2 years ]
- Rate of toxicity of combined niraparib and osimertinib [ Time Frame: 2 years ]
- Objective response rate of niraparib [ Time Frame: 2 years ]
- Median Progression Free Survival time of Niraparib [ Time Frame: 2 Years ]
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): NCT03891615
|Contact: Zofia Piotrowska, MD, MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Michael Cheng, MD email@example.com|
|Principal Investigator: Michael Cheng, MD|
|Massachusetts General Hospital Cancer Center||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Zofia Piotrowska, MD 617-643-9707 firstname.lastname@example.org|
|Principal Investigator: Zofia Piotrowska, MD|
|Sub-Investigator: Henning Willers, MD|
|Beth Israel Deaconess||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Daniel Costa, MD email@example.com|
|Principal Investigator: Daniel Costa, MD|
|Principal Investigator:||Zofia Piotrowska, MD, MPH||Dana-Farber Cancer Institute|