A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients With Borderline Performance Status
Overview
- Phase
- Phase 2
- Intervention
- Computed Tomography
- Conditions
- Not specified
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 47
- Locations
- 340
- Primary Endpoint
- Rate of grade 3-5 adverse events
- Status
- Active, Not Recruiting
- Last Updated
- 19 days ago
Overview
Brief Summary
This phase II trial studies the side effects of radiation therapy followed by atezolizumab in treating patients with stage II or III non-small cell lung cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more cancer cells and have fewer side effects. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to test the safety and effectiveness of radiation therapy followed by atezolizumab and find out what side effects, if any, it has on patient's non-small cell lung cancer.
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the rate of grade 3-5 treatment-related adverse events (TRAEs) in patients who are not candidates for surgery or concurrent chemoradiation and who have either performance status 0-2 and stage II or performance status 2 and stage III non-small cell lung cancer (NSCLC), treated with hypofractionated thoracic radiotherapy followed by atezolizumab. SECONDARY OBJECTIVES: I. To evaluate response rate (confirmed and unconfirmed, complete and partial by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) from Registration Step 2 in the subset of patients with measurable disease. II. To evaluate response rate (confirmed and unconfirmed, complete and partial by RECIST 1.1) during radiation therapy in the subset of patients with measurable disease. III. To evaluate progression free survival (PFS) from Registration Step 2 by RECIST 1.1. IV. To evaluate overall survival (OS) from Registration Step 2. V. To evaluate the frequency and severity of toxicities. ADDITIONAL OBJECTIVE: I. To bank blood and archival tissue for future research. OUTLINE: RADIATION THERAPY: Patients undergo hypofractionated radiation therapy 5 days per week over 3 weeks for 15 fractions in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and may undergo magnetic resonance imaging (MRI) throughout the study, as well as blood sample collection on study. After completion of study treatment, patients are followed up at 6 weeks, every 12 months for the 1 year, then every 6 months until 3 years after study start.
Investigators
Eligibility Criteria
Inclusion Criteria
- •REGISTRATION STEP 1: Participants must have pathologic (cytological or histological) proof of non-small cell lung cancer (NSCLC)
- •REGISTRATION STEP 1: Participants must have stage III NSCLC with Zubrod performance status of 2 or stage II NSCLC with Zubrod performance status of 0-2
- •REGISTRATION STEP 1: Participants must not be candidates for surgical resection in the opinion of the treating investigator. Participants whose disease was previously resected must have experienced local or regional recurrence at least 12 months after resection
- •REGISTRATION STEP 1: Participants must not be candidates for concurrent chemoradiation in the opinion of the treating investigator
- •REGISTRATION STEP 1: Participants must have measurable or non-measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to Registration Step
- •Non-measurable disease must be assessed within 42 days prior to Step 1 registration. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
- •REGISTRATION STEP 1: Participants must have an MRI or CT scan of the brain with contrast within 28 days prior to Registration Step 1
- •REGISTRATION STEP 1: Participants' disease must fit within the radiation constraints in the opinion of a local radiation oncologist
- •REGISTRATION STEP 1: Participants may have received prior treatment for their lung cancer, including surgery, chemotherapy, targeted agents, and/or radiation treatment. At least 12 months must have elapsed since last treatment
- •REGISTRATION STEP 1: Participants may have had prior radiation therapy as long as the irradiated area does not overlap with the radiation field targeted for this study
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (hypofractionated radiation therapy, atezolizumab)
RADIATION THERAPY: Patients undergo hypofractionated radiation therapy 5 days per week over 3 weeks for 15 fractions in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and may undergo MRI throughout the study, as well as blood sample collection on study.
Intervention: Computed Tomography
Treatment (hypofractionated radiation therapy, atezolizumab)
RADIATION THERAPY: Patients undergo hypofractionated radiation therapy 5 days per week over 3 weeks for 15 fractions in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and may undergo MRI throughout the study, as well as blood sample collection on study.
Intervention: Atezolizumab
Treatment (hypofractionated radiation therapy, atezolizumab)
RADIATION THERAPY: Patients undergo hypofractionated radiation therapy 5 days per week over 3 weeks for 15 fractions in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and may undergo MRI throughout the study, as well as blood sample collection on study.
Intervention: Biospecimen Collection
Treatment (hypofractionated radiation therapy, atezolizumab)
RADIATION THERAPY: Patients undergo hypofractionated radiation therapy 5 days per week over 3 weeks for 15 fractions in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and may undergo MRI throughout the study, as well as blood sample collection on study.
Intervention: Hypofractionated Radiation Therapy
Treatment (hypofractionated radiation therapy, atezolizumab)
RADIATION THERAPY: Patients undergo hypofractionated radiation therapy 5 days per week over 3 weeks for 15 fractions in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and may undergo MRI throughout the study, as well as blood sample collection on study.
Intervention: Magnetic Resonance Imaging
Outcomes
Primary Outcomes
Rate of grade 3-5 adverse events
Time Frame: From baseline, until 180 days from Step 2 registration
Individual toxicities with possible, probable or likely attribution to treatment along with the overall rate of grade 3, 4 or 5 toxicities attributable to treatment will be summarized.
Secondary Outcomes
- Incidence of adverse events(Up to 3 years)
- Response rate (confirmed and unconfirmed, complete and partial by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) in the subset of patients with measurable disease (Registration Step 2)(After atezolizumab treatment)
- Response rate (confirmed and unconfirmed, complete and partial by RECIST 1.1) in the subset of patients with measurable disease (Registration Step 1)(During radiation therapy)
- Progression-free survival(From date of Step 2 registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years)
- Overall survival(From date of Step 2 registration to date of death due to any cause, assessed up to 3 years)