- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03557411
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Hypofraction Radiotherapy in Patients With NSCLC
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
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: JINGMIN YU, PhD
- Phone Number: 8653187984729 8613806406293
- Email: jn7984729@public.jn.sd.cn
Study Contact Backup
- Name: LIGANG XING, PhD
- Phone Number: 8653167626819 8618053100188
- Email: xinglg@medmail.com.cn
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250117
- Recruiting
- Shandong Cancer Hospital and Institute
-
Contact:
- Jinming Yu, PhD
- Phone Number: 13806406293
- Email: sdyujinming@126.com
-
Contact:
- Xiangjiao Meng, PhD
- Phone Number: 13793150996
- Email: mengxiangjiao@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR-1210 +Hypofraction radiotherapy
SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
|
SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically significant toxicity
Time Frame: First cycle (28 days)
|
above grade 3 AEs
|
First cycle (28 days)
|
6-month-PFS
Time Frame: From the start of treatment to 6 months.
|
6-month-progression free survival rate
|
From the start of treatment to 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: 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
|
up to 2 years
|
PFS
Time Frame: up to 2 years
|
Progression-Free-Survival
|
up to 2 years
|
AEs+SAEs
Time Frame: from the first drug administration to within 30 days for the last SHR-1210 dose
|
Adverse Events and Serious Adverse Events
|
from the first drug administration to within 30 days for the last SHR-1210 dose
|
ORR
Time Frame: At baseline,at the time point of every 8 weeks
|
Objective Response Rate
|
At baseline,at the time point of every 8 weeks
|
DCR
Time Frame: at the time point of every 8 weeks
|
Disease Control Rate
|
at the time point of every 8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: JINGMIN YU, PhD, Shandong Cancer Hospital and Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1210-RT-IIT-NSCLC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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