A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Hypofraction Radiotherapy in Patients With NSCLC

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Small-Cell Lung Cancer

Intervention / Treatment
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* Drug: SHR-1210


Participation Criteria
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Eligibility Criteria
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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 ECOG 0-1 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. Other clinical trials of drugs were used in the first four weeks of the first medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: SHR-1210 Simultaneously Combined with Hypofraction Radiotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1210 +Hypofraction radiotherapy<br>SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy | Drug: SHR-1210<br>* SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy<br>* Other names: Hypofraction Radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically significant toxicity | above grade 3 AEs | First cycle (28 days) | 
| 6-month-PFS | 6-month-progression free survival rate | From the start of treatment to 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs+SAEs | Adverse Events and Serious Adverse Events | from the first drug administration to within 30 days for the last SHR-1210 dose | 
| PFS | Progression-Free-Survival | up to 2 years | 
| ORR | Objective Response Rate | At baseline,at the time point of every 8 weeks | 
| DCR | Disease Control Rate | at the time point of every 8 weeks | 
| OS | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SHR-1210,radiotherapy,Oligometastases,NSCLC