Clinical trial NCT03557411: A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Hypofraction Radiotherapy in Patients With NSCLC
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Keywords: SHR-1210,radiotherapy,Oligometastases,NSCLC
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2018-06-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SHR-1210 Simultaneously Combined with Hypofraction Radiotherapy
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Clinically significant toxicity
timeFrame: First cycle (28 days)
measure: 6-month-PFS
timeFrame: From the start of treatment to 6 months.
Secondary outcomes:
measure: AEs+SAEs
timeFrame: from the first drug administration to within 30 days for the last SHR-1210 dose
measure: PFS
timeFrame: up to 2 years
measure: ORR
timeFrame: At baseline,at the time point of every 8 weeks
measure: DCR
timeFrame: at the time point of every 8 weeks
measure: OS
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: JINGMIN YU, PhD
role: PRINCIPAL_INVESTIGATOR
References: