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

NCT03262454 | Unknown Phase 2

• 2 other identifiers: NCC2017-0229ML39728
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Small Cell Lung Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response rate using RECIST v1.1

  through study completion, and average of 1 years

Secondary Outcomes (1)

• PFS

  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

Study Arms (1)

Interventions

EXPERIMENTAL

Atezolizumab

Drug: Atezolizumab

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.

Also known as: Tecentriq

Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient aged 18 years or older
• Histologically confirmed SCLC and available tumor tissues for PD-L1 staining
• Progression during or after platinum-based chemotherapy.
• At least one target tumor lesion that has not been irradiated within the past three months and that can accurately be measured in at least one dimension with longest diameter
• Life expectancy of at least three months
• Performance status of 0, 1, 2 on the ECOG criteria
• Adequate hematologic and end-organ function, Patients may be transfused or receive erythropoietic treatment to meet this criterion.
• Patient has given written informed consent which must be consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local legislation

You may not qualify if:

• Previous therapy with anti-PD-1 or -PD-L1 inhibitors
• Persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy
• Chemotherapy, treatment with tyrosine kinase inhibitors, or radiotherapy (except for brain and extremities) within the past 3 weeks prior to treatment with the trial drug i.e., the minimum time elapsed since the last anticancer therapy and the first radiotherapy must be 3 weeks
• Treatment with other investigational drugs or treatment in another clinical trial within the past three weeks before start of therapy or concomitantly with this trial
• Concomitant yellow fever vaccination
• Active or untreated CNS metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for 2 weeks prior to randomization
• Leptomeningeal disease
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Uncontrolled tumor-related pain
• Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
• Significant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 12 months, congestive heart failure \> NYHA II, serious cardiac arrhythmia, pericardial effusion)
• Proteinuria CTCAE grade 2 or greater
• Significant weight loss (\> 10 %) within the past 6 weeks prior to treatment in the present trial
• Current peripheral neuropathy ≥ CTCAE(version4.0) Grade 2 except due to trauma

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Roche Korea co.,Ltd.: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

RECRUITING

MeSH Terms

Interventions

atezolizumab

Study Officials

• Ji-Youn Han, Ph.D.

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji-Youn Han, Ph.D.

CONTACT

+82-31-920-1154; jymama@ncc.re.kr

Sung Jin Yoon

CONTACT

+82-31-920-0399; sjyoon@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: January 22, 2018
• Primary Completion: February 23, 2023
• Study Completion: July 31, 2024
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

KR (1)