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

Shandong First Medical University

Status and phase

Unknown

Phase 2

Conditions

Non-Small-Cell Lung Cancer

Treatments

Drug: SHR-1210

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03557411

SHR-1210-RT-IIT-NSCLC-01

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.