A Phase II Clinical Trial of SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined With Hypofraction Radiotherapy in Patients With Previously Treated Oligometastatic NSCLC

Shandong Cancer Hospital and Institute1 site in 1 country42 target enrollmentJuly 9, 2018

ConditionsNon-Small-Cell Lung Cancer

InterventionsSHR-1210

DrugsSHR-1210

Overview

Phase: Phase 2
Intervention: SHR-1210
Conditions: Non-Small-Cell Lung Cancer
Sponsor: Shandong Cancer Hospital and Institute
Enrollment: 42
Locations: 1
Primary Endpoint: Clinically significant toxicity
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase II clinical trial of SHR-1210 （an anti-PD-1 Inhibitor） simultaneously combined with hypofraction radiotherapy in patients with previously treated oligometastatic NSCLC.

It is a single center, single arm, open label trial. Subjects with oligometastatic non-small-cell lung cancer who is previously treated will be recruited. 12 subjects will be enrolled at the first part of the study which aims to evaluate the tolerability of SHR-1210 in combination with hypofraction radiotherapy. 30 subjects will be enrolled at the second part of the study which aims to evaluate the primary efficacy and safety of SHR-1210 in combination with hypofraction radiotherapy.

Registry

clinicaltrials.gov

Start Date

July 9, 2018

End Date

July 9, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shandong Cancer Hospital and Institute

Responsible Party

Principal Investigator

Jinming Yu

Director of the hospital

Shandong Cancer Hospital and Institute

Eligibility Criteria

Inclusion Criteria

•Subjects will voluntarily participate in this study and sign informed consent.
•NSCLC subject with 1 to 5 distant metastatic lesions in stage IV.
•No clear driven genes (including but not limited to EGFR, ALK).
•Previously received more than 1 chemotherapy regimen and progressed/recurred.
•At least one lesion is suitable for hypofraction radiotherapy.
•There is at least one measurable lesion.
•18 to 75 years old
•The function of vital organs meets the following requirements. ANC≥1.5×10\^9/L, PLT≥100×10\^9/L, Hb≥9g/dL, ALB≥3g/dL, TSH ≤ULN, Bilirubin ≤ 1 times ULN; ALT and AST ≤1.5 times ULN. AKP ≤ 2.5 times ULN. CREA ≤1.5 times ULN or CCr≥60mL/min。
•The estimated survival period is more than 3 months.
•Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.

Exclusion Criteria

•The subjects had any history of autoimmune disease or active autoimmune disease.
•Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry.
•Subjects with severe allergic reactions to other monoclonal antibodies.
•The subjects had a central nervous system metastases of clinical symptoms.
•Central squamous cell lung carcinoma.
•Imaging (CT or MRI) shows that tumors invade large blood vessels or are indistinct with blood vessels.
•Imaging (CT or MRI) showed significant pulmonary vacuity or necrotic tumors,Borderline adenocarcinoma accompanied by a cavity can be considered after discussion with investigator.
•Failing to properly control the clinical symptoms or disease of the heart.
•Subjects had active infections.
•Subjects may receive other systemic antitumor therapy during the study period.

Arms & Interventions

SHR-1210 +Hypofraction radiotherapy

SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy

Intervention: SHR-1210

Outcomes

Primary Outcomes

Clinically significant toxicity

Time Frame: First cycle (28 days)

above grade 3 AEs

6-month-PFS

Time Frame: From the start of treatment to 6 months.

6-month-progression free survival rate

Secondary Outcomes

DCR(at the time point of every 8 weeks)
AEs+SAEs(from the first drug administration to within 30 days for the last SHR-1210 dose)
PFS(up to 2 years)
ORR(At baseline,at the time point of every 8 weeks)
OS(up to 2 years)