Radiation + Immunotherapy for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+176 other locations
Overseen ByRaid Aljumaily
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must not have received steroids in doses higher than prednisone 10 mg daily within 14 days before starting Step 2 of the trial.
What data supports the effectiveness of the treatment Atezolizumab, Tecentriq, Hypofractionated Radiation Therapy, Hypofractionated Radiotherapy, HFRT for Non-Small Cell Lung Cancer?
Research shows that hypofractionated radiation therapy (HFRT) can improve local control and shorten treatment time for inoperable non-small cell lung cancer (NSCLC). Additionally, combining radiation with immunotherapy, like PD-1 targeting drugs, may enhance the immune response against tumors.
12345Is the combination of radiation and immunotherapy safe for treating non-small cell lung cancer?
Studies have shown that hypofractionated radiation therapy (HFRT) is generally well tolerated, but it may increase the risk of gastrointestinal (GI) or genitourinary (GU) side effects. More research is needed to fully understand the safety of combining HFRT with immunotherapy in lung cancer.
35678How is hypofractionated radiation therapy (HFRT) different from other treatments for non-small cell lung cancer?
Hypofractionated radiation therapy (HFRT) is unique because it delivers higher doses of radiation over a shorter period, potentially improving local control and reducing treatment time. When combined with immunotherapy, it may enhance the immune response against tumors, offering a novel approach compared to traditional treatments.
12349Eligibility Criteria
This trial is for adults with stage II or III non-small cell lung cancer who've had prior treatments like surgery, chemo, or radiation but not within the last year. They must have proper liver and kidney function, no severe active infections, HIV under control, and can't be pregnant. People with certain blood counts and those who haven't used high-dose steroids recently can join. It's not for those with autoimmune diseases needing treatment in the past 6 months or a history of significant lung disease.Inclusion Criteria
My cancer can be seen on scans taken within the last 28 to 42 days.
I have never had interstitial lung disease or severe lung inflammation.
I completed my radiation treatment and received at least 44 Gy within the last 42 days.
I haven't needed treatment for an autoimmune disease in the last 6 months.
I haven't taken high doses of steroids in the last 2 weeks.
I do not have any infections that need treatment.
My lung cancer has been confirmed by lab tests.
My lung cancer is stage II or III, and I can care for myself but might not be able to do active work.
Participant Groups
The study tests if giving smaller doses of radiation over time (hypofractionated radiation therapy) before atezolizumab—an immune system-boosting drug—can effectively treat non-small cell lung cancer with fewer side effects than standard treatments.
1Treatment groups
Experimental Treatment
Group I: Treatment (hypofractionated radiation therapy, atezolizumab)Experimental Treatment5 Interventions
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.
Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
🇪🇺 Approved in European Union as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
🇨🇦 Approved in Canada as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Iowa Lutheran HospitalDes Moines, IA
Medical Oncology and Hematology Associates-Des MoinesDes Moines, IA
UT Southwestern Simmons Cancer Center - RedBirdDallas, TX
University of Texas Health Science Center at San AntonioSan Antonio, TX
More Trial Locations
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
References
Hypofractionated three-dimensional conformal radiotherapy for medically inoperable early stage non-small-cell lung cancer. [2021]The purpose of this study was to assess the clinical outcomes of hypofractionated radiotherapy (HFRT) with three-dimensional conformal technique for medically inoperable patients with early stage non-small-cell lung cancer (NSCLC) and to evaluate prognostic factors.
Image guided hypofractionated 3-dimensional radiation therapy in patients with inoperable advanced stage non-small cell lung cancer. [2018]Hypofractionated radiation therapy (HypoRT) can potentially improve local control with a higher biological effect and shorter overall treatment time. Response, local control, toxicity rates, and survival rates were evaluated in patients affected by inoperable advanced stage non-small cell lung cancer (NSCLC) who received HypoRT.
Nivolumab and Hypofractionated Radiotherapy in Patients With Advanced Lung Cancer: ABSCOPAL-1 Clinical Trial. [2022]More clinical practice need to be performed to verify the toxicity of the hypofractionated radiotherapy (HFRT) combined with PD-1 blockade in lung cancer. This phase I study aimed to investigate the safety and efficacy of nivolumab combined with HFRT in patients with progressive advanced lung cancer following multiline treatment.
Fostering efficacy of anti-PD-1-treatment: Nivolumab plus radiotherapy in advanced non-small cell lung cancer - study protocol of the FORCE trial. [2020]Hypofractionated palliative radiotherapy for metastatic lung cancer patients is frequently used in order to ease pain, to increase bone stability, to treat local mass effects, or to prolong progression-free survival at critical sites. Recently introduced, immunotherapy for patients with non-squamous non-small cell lung carcinoma (NSCLC) has significantly improved outcome in this cohort. Preclinical and early clinical data suggest that the combination of photon radiation with programmed death-1 (PD-1) targeting immunotherapies may promote a strong and durable immune response against tumor manifestations both within and beyond radiation targets.
Hypofractionated 3D radiotherapy for inoperable T1-3 N0-1 non-small-cell lung cancer. [2019]This study assessed the toxicity and clinical outcomes of three-dimensional (3D) hypofractionated radiotherapy (HFRT) for medically inoperable T1-3 N0-1 non-small-cell lung cancer (NSCLC).
Safety and efficacy of 10-fraction hypofractionated radiation therapy for non-small cell lung cancer. [2021]To investigate the safety and efficacy of hypofractionated radiation therapy (HFRT) in patients with non-small cell lung cancer who are unfit for surgery or stereotactic body radiation therapy (SBRT) at our institution.
Clinical Outcomes of the CHIRP Trial: A Phase II Prospective Randomized Trial of Conventionally Fractionated Versus Moderately Hypofractionated Prostate and Pelvic Nodal Radiation Therapy in Patients With High-Risk Prostate Cancer. [2021]Hypofractionated radiation therapy (HFRT) may offer treatment advantages for patients with prostate cancer. However, HFRT may also increase the risk of gastrointestinal (GI) or genitourinary (GU) toxicity compared with conventionally fractionated radiation therapy (CFRT). Several large trials have found that HFRT is well tolerated in mixed risk population studies. Here, we report on a phase II, randomized controlled study conducted to evaluate these endpoints in exclusively high-risk patients with prostate cancer treated with prostate and pelvic nodal radiation.
Safety and Tolerability of Metastasis-Directed Radiation Therapy in the Era of Evolving Systemic, Immune, and Targeted Therapies. [2022]Systemic, immune, and target therapies are growing in use in the management of metastatic cancers. The aim of this review was to describe up-to-date published data on the safety and tolerability of metastasis-directed hypofractionated radiation therapy (RT) when combined with newer systemic, immune, and targeted therapies and to provide suggested strategies to mitigate potential toxicities in the clinical setting.
Utilization and Survival Impact of Hypofractionated Radiotherapy in Stage I Non-small Cell Lung Cancer. [2023]The optimal fractionation schedule in unresected stage I non-small cell lung cancer (NSCLC) unsuitable for stereotactic body radiation therapy is unclear. Given the lack of comparative data regarding nonstereotactic body radiation therapy schemas, we compared overall survival (OS) with hypofractionated radiotherapy (HFRT) versus conventionally fractionated radiotherapy (CFRT) and examined the OS impact of different HFRT doses.