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

NCT ID: NCT04560244

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2022-12-31

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.

Conditions

Non-Small-Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR 1701+radiotherapy

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

Group Type: EXPERIMENTAL

SHR1701

Intervention Type: DRUG

PD-L1 / TGF-β RII double antibody

Interventions

SHR1701

PD-L1 / TGF-β RII double antibody

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Jinming Yu

President of Shandong Cancer Hospital and Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JinMing Yu, PhD

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Central Contacts

JinMing Yu, PhD

Role: CONTACT

jn7984729@public.jn.sd.cn

8613806406293 ext. 8653187984729

Other Identifiers

NSCLC-2nd-IIT-SHR1701-RT

Identifier Type: -

Identifier Source: org_study_id