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

Primary Purpose

Non-Small-Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

SHR-1210

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Cancer focused on measuring SHR-1210,radiotherapy,Oligometastases,NSCLC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shandong Cancer Hospital and InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR-1210 +Hypofraction radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Clinically significant toxicity

above grade 3 AEs

6-month-PFS

6-month-progression free survival rate

Secondary Outcome Measures

AEs+SAEs

Adverse Events and Serious Adverse Events

PFS

Progression-Free-Survival

ORR

Objective Response Rate

DCR

Disease Control Rate

OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

Full Information

NCT ID

NCT03557411

First Posted

June 5, 2018

Last Updated

February 3, 2020

Sponsor

Shandong Cancer Hospital and Institute

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03557411

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 9, 2018 (Actual)

Primary Completion Date

July 9, 2020 (Anticipated)

Study Completion Date

July 9, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong Cancer Hospital and Institute

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small-Cell Lung Cancer

Keywords

SHR-1210,radiotherapy,Oligometastases,NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

SHR-1210 Simultaneously Combined with Hypofraction Radiotherapy

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SHR-1210 +Hypofraction radiotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SHR-1210

Other Intervention Name(s)

Hypofraction Radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinically significant toxicity

Description

above grade 3 AEs

Time Frame

First cycle (28 days)

Title

6-month-PFS

Description

6-month-progression free survival rate

Time Frame

From the start of treatment to 6 months.

Secondary Outcome Measure Information:

Title

AEs+SAEs

Description

Adverse Events and Serious Adverse Events

Time Frame

from the first drug administration to within 30 days for the last SHR-1210 dose

Title

PFS

Description

Progression-Free-Survival

Time Frame

up to 2 years

Title

ORR

Description

Objective Response Rate

Time Frame

At baseline,at the time point of every 8 weeks

Title

DCR

Description

Disease Control Rate

Time Frame

at the time point of every 8 weeks

Title

Description

OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

Time Frame

up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

JINGMIN YU, PhD

Phone

8613806406293

Ext

8653187984729

jn7984729@public.jn.sd.cn

First Name & Middle Initial & Last Name or Official Title & Degree

LIGANG XING, PhD

Phone

8618053100188

Ext

8653167626819

xinglg@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JINGMIN YU, PhD

Organizational Affiliation

Shandong Cancer Hospital and Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shandong Cancer Hospital and Institute

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250117

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jinming Yu, PhD

Phone

13806406293

sdyujinming@126.com

First Name & Middle Initial & Last Name & Degree

Xiangjiao Meng, PhD

Phone

13793150996

mengxiangjiao@126.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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