Non-Small-Cell Lung Cancer
Conditions
Keywords
SHR-1210,radiotherapy,Oligometastases,NSCLC
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.
Interventions
DRUGSHR-1210
SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SHR-1210 Simultaneously Combined with Hypofraction Radiotherapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant toxicity | First cycle (28 days) | above grade 3 AEs |
| 6-month-PFS | From the start of treatment to 6 months. | 6-month-progression free survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | At baseline,at the time point of every 8 weeks | Objective Response Rate |
| AEs+SAEs | from the first drug administration to within 30 days for the last SHR-1210 dose | Adverse Events and Serious Adverse Events |
| OS | up to 2 years | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up |
| DCR | at the time point of every 8 weeks | Disease Control Rate |
| PFS | up to 2 years | Progression-Free-Survival |
Countries
China
Contacts
Primary ContactJINGMIN YU, PhD
Backup ContactLIGANG XING, PhD
Outcome results
None listed