Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Maximilian Diehn

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Biological: Fresolimumab
  • Other: Pharmacological Study
  • Radiation: Stereotactic Body Radiation Therapy

Phase:

Phase 1/Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Madelyn Kissel
650-497-8966
Recruiting