Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01829217
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2013-04-09
Brief Title:
Sunitinib in Never-Smokers With Lung Adenocarcinoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Trial of Sunitinib in Never-smokers With Lung Adenocarcinoma Identification of Oncogenic Alterations Underlying Sunitinib Sensitivity
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is a Phase II clinical trial which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer Investigational means that the drug is being studied It also means that the FDA has not yet approved sunitinib for your type of cancer
Sunitinib has been approved by the FDA for treatment of gastrointestinal stromal tumors advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors While most chemotherapies work by interfering with cancer cell replication sunitinib works by blocking certain protein signals within the cell Because sunitinib works differently from standard intravenous chemotherapies we call it a targeted therapy This drug has also been used in other research studies and information from those other research studies suggests that this agent may help to slow the growth of some NSCLC tumors
In this research study we are looking to see if sunitinib may stop certain NSCLC tumors from growing The study focuses on a type of NSCLC adenocarcinoma which has previously been found to be more sensitive to other kinds of oral targeted therapies This study will focus specifically on 1 adenocarcinoma tumors that do not carry a mutation in a known cancer gene EGFR KRAS or ALK and occur in patients that never smoked less than 100 cigarettes in their lifetime or 2 adenocarcinoma tumors that have a mutation in the RET gene
Sunitinib has been approved by the FDA for treatment of gastrointestinal stromal tumors advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors While most chemotherapies work by interfering with cancer cell replication sunitinib works by blocking certain protein signals within the cell Because sunitinib works differently from standard intravenous chemotherapies we call it a targeted therapy This drug has also been used in other research studies and information from those other research studies suggests that this agent may help to slow the growth of some NSCLC tumors
In this research study we are looking to see if sunitinib may stop certain NSCLC tumors from growing The study focuses on a type of NSCLC adenocarcinoma which has previously been found to be more sensitive to other kinds of oral targeted therapies This study will focus specifically on 1 adenocarcinoma tumors that do not carry a mutation in a known cancer gene EGFR KRAS or ALK and occur in patients that never smoked less than 100 cigarettes in their lifetime or 2 adenocarcinoma tumors that have a mutation in the RET gene
Detailed Description:
Primary Objectives
- To evaluate the objective response rate ORR to sunitinib in never-smokers with lung cancers that are wild-type for EGFR KRAS and ALK in a single-arm phase II trial
Secondary Objectives
To identify oncogenic alterations underlying sensitivity to sunitinib through performing nextgeneration sequencing NGS of lung cancers treated with sunitinib
To explore the activity of sunitinib in lung cancers known to harbor a RET rearrangements and other genomic alterations in targets of sunitinib eg cKIT PDGFRa PDGFRb
- To evaluate the objective response rate ORR to sunitinib in never-smokers with lung cancers that are wild-type for EGFR KRAS and ALK in a single-arm phase II trial
Secondary Objectives
To identify oncogenic alterations underlying sensitivity to sunitinib through performing nextgeneration sequencing NGS of lung cancers treated with sunitinib
To explore the activity of sunitinib in lung cancers known to harbor a RET rearrangements and other genomic alterations in targets of sunitinib eg cKIT PDGFRa PDGFRb
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None