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

• Status: Recruiting
• Trial end date: 2020-07-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.