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A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment

Primary Purpose

Non-Small-Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SHR1701

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Cancer focused on measuring SHR1701,radiotherapy,NSCLC

Eligibility Criteria

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

Inclusion Criteria:

Subjects voluntarily participate in this study and sign informed consent.
NSCLC in stage IV.
No clear driven genes (including but not limited to EGFR、ALK、ROS1、cMET).
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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR 1701+radiotherapy

Arm Description

SHR-1701 Simultaneously Combined with High Fractionation and Low-dose Radiotherapy

Outcomes

Primary Outcome Measures

Number of participants experiencing adverse event (AE)

Number of participants experiencing serious adverse event (SAE)

Secondary Outcome Measures

progression-free survival （PFS）

Objective Response Rate （ORR）

Disease control rate (DCR)

Overall survival (OS)

Full Information

NCT ID

NCT04560244

First Posted

September 11, 2020

Last Updated

September 17, 2020

Sponsor

Shandong Cancer Hospital and Institute

1. Study Identification

Unique Protocol Identification Number

NCT04560244

Brief Title

A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment

Official Title

Director of Shandong Cancer Hospital and Institute

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 2020 (Anticipated)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong Cancer Hospital and Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is a single center, single arm, open study design. The main purpose of this study is to evaluate the tolerance and efficacy of SHR1701 with synchronous radiotherapy in patients with metastatic non-small cell lung cancer who have failed after systematic treatment. Large fraction radiotherapy is given to all lesions as much as possible, and low-dose radiotherapy is given to the lesions that cannot be tolerated or have no obvious benefit.

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

SHR1701,radiotherapy,NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SHR 1701+radiotherapy

Arm Type

Experimental

Arm Description

SHR-1701 Simultaneously Combined with High Fractionation and Low-dose Radiotherapy

Intervention Type

Drug

Intervention Name(s)

SHR1701

Intervention Description

PD-L1 / TGF-β RII double antibody

Primary Outcome Measure Information:

Title

Number of participants experiencing adverse event (AE)

Time Frame

From the first administration of shr-1701 to 90 days after the last Administration

Title

Number of participants experiencing serious adverse event (SAE)

Time Frame

From the first administration of shr-1701 to 90 days after the last Administration

Secondary Outcome Measure Information:

Title

progression-free survival （PFS）

Time Frame

Up to approximately 24 months

Title

Objective Response Rate （ORR）

Time Frame

Up to approximately 24 months

Title

Disease control rate (DCR)

Time Frame

Up to approximately 24 months

Title

Overall survival (OS)

Time Frame

Up to approximately 24 months

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 voluntarily participate in this study and sign informed consent. NSCLC in stage IV. No clear driven genes (including but not limited to EGFR、ALK、ROS1、cMET). 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

JinMing Yu, PhD

Phone

8613806406293

Ext

8653187984729

jn7984729@public.jn.sd.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JinMing Yu, PhD

Organizational Affiliation

Shandong Cancer Hospital and Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment

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