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SABR-ATAC: A Trial of TGF-beta Inhibition and Stereotactic Ablative Radiotherapy for Early Stage Non-small Cell Lung Cancer

Trial ID or NCT#

NCT02581787

Status

RECRUITING

Purpose

The SABR-ATAC trial (Stereotactic Ablative Radiotherapy and anti-TGFB Antibody Combination) is a phase I/II trial that studies the side effects and efficacy of fresolimumab, an anti-transforming growth factor beta (TGFB) antibody, when given with stereotactic ablative radiotherapy in patients with stage IA-IB non-small cell lung cancer. Fresolimumab may inhibit radiation side effects and block tumor growth through multiple mechanisms. Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiotherapy (SBRT), is a specialized form of radiation therapy that precisely delivers high dose radiation directly to tumors, thus killing tumor cells and minimizing damage to normal tissue. Giving fresolimumab with SABR may work better in treating patients with early stage non-small cell lung cancer than treating with SABR alone.

Official Title

Fresolimumab and Stereotactic Ablative Radiotherapy in Early Stage Non-small Cell Lung Cancer

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Inclusion Criteria:

- Newly diagnosed, histologically proven (or strongly suspected, see below) T1-T2aN0M0 (Stage IA-IB) non-small cell lung cancer (NSCLC), with maximum tumor diameter =< 5 cm under consideration for stereotactic ablative body radiotherapy (SABR) as definitive primary treatment
- Pathologic confirmation of NSCLC diagnosis is recommended whenever possible; this will generally be accomplished using computed tomography (CT) guided or bronchoscopic biopsies; if pathologic confirmation is not possible, a target lesion must be a non calcified pulmonary nodule that is present on at least 2 imaging studies (can include simulation scan); the nodule must have increased in size or proportion of solid component on CT and/or show increased fluorodeoxyglucose (FDG) uptake on positron emission tomography (PET) over at least 2 imaging studies
- No history of prior radiotherapy overlapping with high dose region of planned SABR course
- No prior receipt of systemic treatment (chemotherapy, targeted therapy, or immunotherapy) for the lesion under consideration of treatment
- No uncontrolled, inter-current or recent illness that in the investigator's opinion precludes participation in the study, including those undergoing therapy for a separate invasive malignancy
- Able to give informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2

Exclusion Criteria:

- No significant anemia (hemoglobin below 9.0 g/dL) or neutropenia (absolute neutrophil count [ANC] < 1000/mm^3)
- No prior history of lung resection on ipsilateral side
- No prior history of multifocal adenocarcinoma in situ (ie, classic or pure bronchioloalveolar carcinoma)
- No prior history of idiopathic pulmonary fibrosis
- No prior history of keratoacanthoma (well differentiated squamous cell skin cancer variant, often centrally ulcerated); history of basal cell cancer is allowed
- No contraindication to receiving radiotherapy and no known allergy to components of fresolimumab
- No pregnant or breastfeeding women; men or women of child bearing potential must agree to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for at least 90 days after last study treatment (radiation or fresolimumab); all women of child bearing potential (last menstrual period within the previous 12 months and not surgically sterile) will be tested for pregnancy at pre-entry

View All Criteria

Investigator(s)

Maximilian Diehn, MD, PhD

Radiation oncologist

Associate Professor of Radiation Oncology (Radiation Therapy)

Billy W. Loo, Jr., MD, PhD, DABR

Radiation oncologist, Thoracic specialist

Associate Professor of Radiation Oncology (Radiation Therapy) at the Stanford University Medical Center

CONTACT

Madelyn Kissel
(650) 497-8966

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View on ClinicalTrials.gov

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