A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Hypofraction Radiotherapy in Patients With NSCLC

Non-Small-Cell Lung Cancer Clinical Trial

Official title:

A Phase II Clinical Trial of SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined With Hypofraction Radiotherapy in Patients With Previously Treated Oligometastatic NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03557411
• Other study ID #: SHR-1210-RT-IIT-NSCLC-01
• Status: Recruiting
• Phase: Phase 2
• Start date: July 9, 2018
• Est. completion date: July 9, 2020

Study information

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

Clinical Trial Summary

This is a phase II clinical trial of SHR-1210 （an anti-PD-1 Inhibitor） simultaneously combined with hypofraction radiotherapy in patients with previously treated oligometastatic NSCLC.

It is a single center, single arm, open label trial. Subjects with oligometastatic non-small-cell lung cancer who is previously treated will be recruited. 12 subjects will be enrolled at the first part of the study which aims to evaluate the tolerability of SHR-1210 in combination with hypofraction radiotherapy. 30 subjects will be enrolled at the second part of the study which aims to evaluate the primary efficacy and safety of SHR-1210 in combination with hypofraction radiotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: July 9, 2020
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects will voluntarily participate in this study and sign informed consent.

• NSCLC subject with 1 to 5 distant metastatic lesions in stage IV.

• No clear driven genes (including but not limited to EGFR, ALK).

• 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
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• SHR-1210
SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy

Locations

Country	Name	City	State
China	Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically significant toxicity	above grade 3 AEs	First cycle (28 days)
Primary	6-month-PFS	6-month-progression free survival rate	From the start of treatment to 6 months.
Secondary	AEs+SAEs	Adverse Events and Serious Adverse Events	from the first drug administration to within 30 days for the last SHR-1210 dose
Secondary	PFS	Progression-Free-Survival	up to 2 years
Secondary	ORR	Objective Response Rate	At baseline,at the time point of every 8 weeks
Secondary	DCR	Disease Control Rate	at the time point of every 8 weeks
Secondary	OS	OS is the time interval from the start of treatment to death due to any reason or lost of follow-up	up to 2 years