Back to results

Sunitinib in Never-Smokers With Lung Adenocarcinoma

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sunitinib

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed advanced (stage IV or recurrent) non-small cell lung cancer
Adenocarcinoma histology of any variant, including adenosquamous histology
Wild-type for mutations in EGFR, KRAS and ALK
Must have < 100 cigarettes smoked lifetime OR known to harbor a RET rearrangement OR another potentially targetable genomic alteration as defined per protocol
Disease must be measureable per RECIST 1.1
At least one prior systemic therapy (adjuvant or palliative)
18 years or older
Life expectancy of greater than 4 weeks
Adequate ECOG performance status 0 or 1
Adequate organ function as defined in the protocol
Adequate tumor tissue for the correlative analyses on study, or must undergo a biopsy to obtain adequate tissue

Exclusion Criteria:

Pregnant or breastfeeding
Chemotherapy within 4 weeks of entering study, or lack of recover from adverse events to grade 1 or less due to systemic agents administered more than 4 weeks earlier
Radiation therapy within 2 weeks prior to entering study
Major surgery within 4 weeks prior to entering the study
Receiving any other investigational agents
Known untreated, symptomatic or progressive brain metastases; presence of carcinomatous meningitis; history of intracranial hemorrhage or brain metastases requiring chronic steroids
History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib
Use of certain inhibitors and inducers of CYP3A4
Grade 3 or 4 hemoptysis or hemorrhage within 4 weeks prior to study entry
History of significant bleeding disorder unrelated to cancer
Poorly controlled hypertension
Severe cardiovascular disease
Prolongation of corrected QT interval
History of a different malignancy except: cervical cancer in situ, basal or squamous cell carcinoma of the skin, low risk centralized prostate cancer
HIV positive on combination antiretroviral therapy

Sites / Locations

Massachusetts General Hospital
Beth Isreal Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib

Arm Description

42 day cycle, taken orally every day for the first 28 days followed by 14 days off

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Percentage of patients with evidence of complete or partial response per RECIST1.1 criteria.

Secondary Outcome Measures

Full Information

NCT ID

NCT01829217

First Posted

April 9, 2013

Last Updated

October 3, 2018

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT01829217

Brief Title

Sunitinib in Never-Smokers With Lung Adenocarcinoma

Official Title

A Phase II Trial of Sunitinib in Never-smokers With Lung Adenocarcinoma: Identification of Oncogenic Alterations Underlying Sunitinib Sensitivity

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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 (e.g. cKIT, PDGFRa, PDGFRb).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sunitinib

Arm Type

Experimental

Arm Description

42 day cycle, taken orally every day for the first 28 days followed by 14 days off

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Percentage of patients with evidence of complete or partial response per RECIST1.1 criteria.

Time Frame

ORR was assessed at 6 weeks post-registration and every 6 weeks until date of documented disease progression or death, up to January 23, 2017 (approximately 44 months).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed advanced (stage IV or recurrent) non-small cell lung cancer Adenocarcinoma histology of any variant, including adenosquamous histology Wild-type for mutations in EGFR, KRAS and ALK Must have < 100 cigarettes smoked lifetime OR known to harbor a RET rearrangement OR another potentially targetable genomic alteration as defined per protocol Disease must be measureable per RECIST 1.1 At least one prior systemic therapy (adjuvant or palliative) 18 years or older Life expectancy of greater than 4 weeks Adequate ECOG performance status 0 or 1 Adequate organ function as defined in the protocol Adequate tumor tissue for the correlative analyses on study, or must undergo a biopsy to obtain adequate tissue Exclusion Criteria: Pregnant or breastfeeding Chemotherapy within 4 weeks of entering study, or lack of recover from adverse events to grade 1 or less due to systemic agents administered more than 4 weeks earlier Radiation therapy within 2 weeks prior to entering study Major surgery within 4 weeks prior to entering the study Receiving any other investigational agents Known untreated, symptomatic or progressive brain metastases; presence of carcinomatous meningitis; history of intracranial hemorrhage or brain metastases requiring chronic steroids History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib Use of certain inhibitors and inducers of CYP3A4 Grade 3 or 4 hemoptysis or hemorrhage within 4 weeks prior to study entry History of significant bleeding disorder unrelated to cancer Poorly controlled hypertension Severe cardiovascular disease Prolongation of corrected QT interval History of a different malignancy except: cervical cancer in situ, basal or squamous cell carcinoma of the skin, low risk centralized prostate cancer HIV positive on combination antiretroviral therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Geoffrey Oxnard, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02214

Country

United States

Facility Name

Beth Isreal Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32312893

Citation

Cooper AJ, Kobayashi Y, Kim D, Clifford SE, Kravets S, Dahlberg SE, Chambers ES, Li J, Rangachari D, Nguyen T, Costa DB, Rabin MS, Wagle N, Sholl LM, Janne PA, Oxnard GR. Identification of a RAS-activating TMEM87A-RASGRF1 Fusion in an Exceptional Responder to Sunitinib with Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Aug 1;26(15):4072-4079. doi: 10.1158/1078-0432.CCR-20-0397. Epub 2020 Apr 20.

Results Reference

derived

PubMed Identifier

26291023

Citation

Wu H, Shih JY, Yang JC. Rapid Response to Sunitinib in a Patient with Lung Adenocarcinoma Harboring KIF5B-RET Fusion Gene. J Thorac Oncol. 2015 Sep;10(9):e95-e96. doi: 10.1097/JTO.0000000000000611. No abstract available.

Results Reference

derived

Learn more about this trial

Sunitinib in Never-Smokers With Lung Adenocarcinoma

We'll reach out to this number within 24 hrs