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: Varian

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

   - Patient judged to be inoperable or at high surgical risk by a board qualified thoracic
   cancer surgeon who has evaluated the subject within the prior 12 weeks, or the
   patient's case has been discussed at a multidisciplinary tumor board with a thoracic
   cancer surgeon in attendance, or a patient who refuses surgery or declines to be
   evaluated for surgery.

   - Able to give informed consent

   - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2

   - 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)

Exclusion Criteria:

   - Significant anemia (hemoglobin below 9.0 g/dL) or neutropenia (absolute neutrophil
   count [ANC] < 1000/mm^3)

   - Prior history of multifocal adenocarcinoma in situ (ie, classic or pure
   bronchioloalveolar carcinoma)

   - Prior history of keratoacanthoma (well differentiated squamous cell skin cancer
   variant, often centrally ulcerated); history of basal cell cancer is allowed

   - Pre malignant skin lesion(s) noted on prescreening skin exam, except for actinic
   (solar) keratosis

   - Prior radiotherapy overlapping with high dose region of planned SABR course

   - Prior history of head and neck; oral; or bladder cancer

   - Prior receipt of systemic treatment (chemotherapy, targeted therapy, or immunotherapy)
   for the lesion under consideration of treatment

   - 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

   - Contraindication to receiving radiotherapy

   - Known allergy to components of fresolimumab

   - Pregnant or breastfeeding. 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
Samantha Wong
650-498-8495
Recruiting