A Phase 2 interventional study of Atezolizumab in Small Cell Lung Cancer Recurrent, sponsored by National Cancer Center, Korea. Status unknown at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Treatment
The investigators hypothesized that local radiation therapy can enhance the effect of anti-PD-L1 monoclonal antibody through priming T-cell effector function against cancer cells. Described as above, The investigators concluded that modest dose of radiation to local site prior to immunotherapy is the best to enhance T-cell-mediated immunity. Accordingly, The investigators will investigate the combining effect of hypofractionated-sublethal dose of radiation therapy followed by anti-PD-L1 monoclonal antibody, atezolizumab, for SCLC patients who are recurrent or refractory for initial platinum-based chemotherapy
Small cell lung cancer (SCLC), accounting for 10% of all lung cancers (Torre et al., 2015), shows poor outcomes with 7-10 months of median survival in advanced cases (Jett et al., 2013). Despite novel treatment strategies including targeted therapy and immunotherapy for non-small cell lung cancer (NSCLC) have been introduced, the treatment options for SCLC still remain limited. Many clinical trials, which tested the efficacy of molecular targeted agents for SCLC, failed to show clinical benefit compared with conventional platinum-based chemotherapy (Koinis et al., 2016). Nevertheless, recent studies demonstrated that immunotherapy using anti-CTLA-4 or anti-PD1 monoclonal antibody can be novel therapeutic strategies for SCLC (Ott et al., 2015; Reck et al., 2013; SJ et al., 2015).
In recent years, many studies have shown that radiation therapy can be a useful treatment as a combining treatment with immunotherapy. The abscopal effect refers to the ability of radiation delivered radiation delivered to a local site to treat the other diseases outside radiation field (Tang et al., 2014). A recent study described that abscopal effect was observed in a malignant melanoma patient treated with CTLA4 antagonist and radiotherapy (Postow et al., 2012). Moreover, an animal study presented that blockade of PD-L1 and ionizing radiation showed synergism (Deng et al., 2014). Based on these emerging evidences, the investigators hypothesized that local radiation therapy can enhance the effect of anti-PD-L1 monoclonal antibody through increasing T-cell effector function against tumors. Atezolizumab, which is a humanized anti-PD-L1 monoclonal antibody, act as an inhibitor the interaction between PD-L1 and PD-1, and eventually restore suppressed T-cell immunity leading elimination of cancer cells. In this study, the investigators will investigate the combining effect of hypofractionated-sublethal dose of radiation therapy followed by anti-PD-L1 monoclonal antibody, atezolizumab, for SCLC patients who are recurrent or refractory for initial platinum-based chemotherapy.
Based on these emerging evidences, the investigators hypothesized that local radiation therapy can enhance the effect of anti-PD-L1 monoclonal antibody through priming T-cell effector function against cancer cells. Described as above, the investigators concluded that modest dose of radiation to local site prior to immunotherapy is the best to enhance T-cell-mediated immunity.
National Cancer Center, Korea is the lead sponsor of 203 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Atezolizumab
Drug: Atezolizumab
Patients undergo hypofractionated radiation therapy with 24 Gy over 4 fractions in days 1-4 of 1st cycle of atezolimumab and receive Atezolizumab 1200 mg fixed dose via intravenous on day 1 of each 3-week cycle until disease progression or unacceptable toxicity occurs.
Also known as: Tecentriq
ORR
Objective Response rate using RECIST v1.1
Time frame: through study completion, and average of 1 years
PFS
Progression Free Survival
Time frame: From date of enroll until the date of first documented progression or date of death from any cause, whichever came first, assessed up to at least 12 months
Started Jan 2018 (actual). Primary completion is estimated for Feb 2023, 61 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Atezolizumab
National Cancer Center, Korea →