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

Non-Small-Cell Lung Cancer Clinical Trial

Official title:

Director of Shandong Cancer Hospital and Institute

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04560244
• Other study ID #: NSCLC-2nd-IIT-SHR1701-RT
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2020
• Est. completion date: December 2022

Study information

• Verified date: September 2020
• Source: Shandong Cancer Hospital and Institute
• Contact: JinMing Yu, PhD
• Phone: 8613806406293
• Email: jn7984729[@]public.jn.sd.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• SHR1701
PD-L1 / TGF-ß RII double antibody

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing adverse event (AE)		From the first administration of shr-1701 to 90 days after the last Administration
Primary	Number of participants experiencing serious adverse event (SAE)		From the first administration of shr-1701 to 90 days after the last Administration
Secondary	progression-free survival (PFS)		Up to approximately 24 months
Secondary	Objective Response Rate (ORR)		Up to approximately 24 months
Secondary	Disease control rate (DCR)		Up to approximately 24 months
Secondary	Overall survival (OS)		Up to approximately 24 months