SABR-ATAC: A Trial of TGF-beta Inhibition and Stereotactic Ablative Radiotherapy for Early Stage Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02581787|
Recruitment Status : Active, not recruiting
First Posted : October 21, 2015
Last Update Posted : December 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stage IA Non-Small Cell Lung Carcinoma Stage IB Non-Small Cell Lung Carcinoma||Biological: Fresolimumab Other: Pharmacological Study Radiation: Stereotactic Body Radiation Therapy||Phase 1 Phase 2|
Phase 1: Evaluate the safe dose of fresolimumab in combination with stereotactic ablative radiotherapy (SABR) in patients.
Phase 2. Evaluate the rate of radiation induced pulmonary fibrosis after SABR plus fresolimumab.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fresolimumab and Stereotactic Ablative Radiotherapy in Early Stage Non-small Cell Lung Cancer|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Treatment (fresolimumab, SABR)
In Phase 1: Patients receive fresolimumab IV on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12 in total of 5 subjects. In Phase 2: . Fresolimumab will be administered IV at the dose selected in the preceding Phase 1 on Days 1, 15 and 36 and SABR will be administered in 4 fractions between Days 8 and 12.
Other: Pharmacological Study
Radiation: Stereotactic Body Radiation Therapy
Other Name: SBRT
- Dose limiting toxicities (DLTs) of fresolimumab when combined with SABR defined as Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher radiation pneumonitis or bronchopulmonary hemorrhage (Phase I) [ Time Frame: Up to 30 days ]
Dose limiting toxicity (DLT) is defined as the following grade 3; 4; or 5 CTCAE v4 events determined to be of possibly; probably; of definite relationship to treatment; occurring after 1st dose of fresolimumab and up to 30 days after the last dose of fresolimumab:
- Radiation pneumonitis, or
- Bronchopulmonary hemorrhage A safe dose of fresolimumab is reached when =< 10% of the patients receiving fresolimumab plus SABR develop DLTs.
- Presence of late radiation induced fibrosis (Phase II) [ Time Frame: Up to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581787
|United States, California|
|Stanford University, School of Medicine|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Maximilian Diehn||Stanford Cancer Institute|