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Trial record 73 of 5013 for:    NSCLC

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

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ClinicalTrials.gov Identifier: NCT03557411
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Jinming Yu, 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.


Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: SHR-1210 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Intervention Model Description: SHR-1210 Simultaneously Combined with Hypofraction Radiotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : July 9, 2019
Estimated Study Completion Date : July 9, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SHR-1210 +Hypofraction radiotherapy
SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
Drug: SHR-1210
SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
Other Name: Hypofraction Radiotherapy




Primary Outcome Measures :
  1. Clinically significant toxicity [ Time Frame: First cycle (28 days) ]
    above grade 3 AEs

  2. 6-month-PFS [ Time Frame: From the start of treatment to 6 months. ]
    6-month-progression free survival rate


Secondary Outcome Measures :
  1. 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

  2. PFS [ Time Frame: up to 2 years ]
    Progression-Free-Survival

  3. ORR [ Time Frame: At baseline,at the time point of every 8 weeks ]
    Objective Response Rate

  4. DCR [ Time Frame: at the time point of every 8 weeks ]
    Disease Control Rate

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557411


Contacts
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Contact: JINGMIN YU, PhD 8613806406293 ext 8653187984729 jn7984729@public.jn.sd.cn
Contact: LIGANG XING, PhD 8618053100188 ext 8653167626819 xinglg@medmail.com.cn

Locations
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China, Shandong
Shandong Cancer Hospital and Institute Recruiting
Jinan, Shandong, China, 250117
Contact: Jinming Yu, PhD    13806406293    sdyujinming@126.com   
Contact: Xiangjiao Meng, PhD    13793150996    mengxiangjiao@126.com   
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: JINGMIN YU, PhD Shandong Cancer Hospital

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Responsible Party: Jinming Yu, Director of the hospital, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT03557411     History of Changes
Other Study ID Numbers: SHR-1210-RT-IIT-NSCLC-01
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jinming Yu, Shandong Cancer Hospital and Institute:
SHR-1210,radiotherapy,Oligometastases,NSCLC

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases