Sequential Hypofractionated Radiotherapy Followed by Anti-PD-L1 Atezolizumab for SCLC

Sponsor
National Cancer Center, Korea
Study ID
NCT03262454
Phase
PHASE2
Status
Unknown

Conditions

  • Small Cell Lung Cancer Recurrent

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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.

Study Details

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

Key Dates

Start date
Jan 22, 2018
Status verified
Apr 2022
Primary completion
Feb 23, 2023
Completion
Jul 31, 2024

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Interventions
    Atezolizumab

Primary Outcome Measure

ORR [ Time Frame: through study completion, and average of 1 years ]

Central Contacts