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

Phase 2

• Conditions: Non-Small-Cell Lung Cancer
• Interventions: Drug: SHR1701

• Registration Number: NCT04560244
• Lead Sponsor: Shandong Cancer Hospital and Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-17
• Last Update Submitted: 2020-09-17
• Study First Posted: 2020-09-23
• Last Update Posted: 2020-09-23
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR 1701+radiotherapy	SHR1701	SHR-1701 Simultaneously Combined with High Fractionation and Low-dose Radiotherapy

Primary Outcome Measures

Name	Time	Method
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

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