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

Director of Shandong Cancer Hospital and Institute

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.

Study Overview

• Status: Unknown
• Conditions: Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: SHR1701

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SHR 1701+radiotherapy; SHR-1701 Simultaneously Combined with High Fractionation and Low-dose Radiotherapy	Drug: SHR1701; PD-L1 / TGF-β RII double antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants experiencing adverse event (AE)	From the first administration of shr-1701 to 90 days after the last Administration
Number of participants experiencing serious adverse event (SAE)	From the first administration of shr-1701 to 90 days after the last Administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease control rate (DCR)	Up to approximately 24 months
progression-free survival （PFS）	Up to approximately 24 months
Objective Response Rate （ORR）	Up to approximately 24 months
Overall survival (OS)	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (ACTUAL): September 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: SHR1701,radiotherapy,NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: NSCLC-2nd-IIT-SHR1701-RT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No