A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Hypofraction Radiotherapy in Patients With NSCLC
- Registration Number
- NCT03557411
- Lead Sponsor
- Shandong Cancer Hospital and Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SHR-1210 +Hypofraction radiotherapy SHR-1210 SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method AEs+SAEs from the first drug administration to within 30 days for the last SHR-1210 dose Adverse Events and Serious Adverse Events
PFS up to 2 years Progression-Free-Survival
ORR At baseline,at the time point of every 8 weeks Objective Response Rate
DCR at the time point of every 8 weeks Disease Control Rate
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
Trial Locations
- Locations (1)
Shandong Cancer Hospital and Institute
🇨🇳Jinan, Shandong, China