Lung Cancer
Conditions
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).
Interventions
DRUGSunitinib
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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). | Percentage of patients with evidence of complete or partial response per RECIST1.1 criteria. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib 42 day cycle, taken orally every day for the first 28 days followed by 14 days off
Sunitinib | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Sunitinib |
|---|---|
| Age, Continuous | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 13 |
| other Total, other adverse events | 9 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Objective Response Rate (ORR)
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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib | Objective Response Rate (ORR) | 7.69 percentage of participants |