Palo Alto, California 94304


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.


Study summary:

PRIMARY OBJECTIVES: I. Evaluate the safe dose of fresolimumab in combination with stereotactic ablative radiotherapy (SABR) in patients. (Phase I) II. Evaluate the rate of radiation induced pulmonary fibrosis after SABR plus fresolimumab. (Phase II) SECONDARY OBJECTIVES: I. Evaluate potential adverse events in patients receiving fresolimumab plus SABR. (Phase I) II. Evaluate post treatment changes in pulmonary function. (Phase I) III. Evaluate recurrence rates and progression free survival. (Phase I) IV. Assess pharmacokinetics (PK) of fresolimumab in combination with SABR (optional for patient). (Phase I) V. Evaluate the rate and severity of radiation induced pulmonary fibrosis after SABR plus fresolimumab. (Phase I) VI. Evaluate the severity of radiation induced pulmonary fibrosis after SABR plus fresolimumab. (Phase II) VII. Evaluate potential adverse events in patients receiving fresolimumab plus SABR. (Phase II) VIII. Evaluate post treatment changes in pulmonary function. (Phase II) IX. Evaluate recurrence rates and progression free survival. (Phase II) OUTLINE: This is a phase I, dose escalation study of fresolimumab followed by a phase II study. Patients receive fresolimumab intravenously (IV) on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12. After completion of study treatment, patients are followed up at 3, 6, and 12 months.


Criteria:

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


NCT ID:

NCT02581787


Primary Contact:

Principal Investigator
Maximilian Diehn
Stanford Cancer Institute


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94304
United States

Rachel Freilberg
Phone: 650-725-0438
Email: rachelf@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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