CClinicalTrials.gg
Status unknownNCT03557411Updated Feb 5, 2020

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

A Phase 2 interventional study of SHR-1210 in Non-Small-Cell Lung Cancer, sponsored by Shandong Cancer Hospital and Institute. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Shandong Cancer Hospital and Institute · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Non-Small-Cell Lung Cancer

Keywords

  • SHR-1210,radiotherapy,Oligometastases,NSCLC
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 42 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Shandong Cancer Hospital and Institute is the lead sponsor of 103 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    SHR-1210 +Hypofraction radiotherapy

    SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy

    Drug: SHR-1210

Interventions

  • DrugSHR-1210

    SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy

    Also known as: Hypofraction Radiotherapy

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What researchers measure

Primary outcomes

  1. Clinically significant toxicity

    above grade 3 AEs

    Time frame: First cycle (28 days)

  2. 6-month-PFS

    6-month-progression free survival rate

    Time frame: From the start of treatment to 6 months.

Secondary outcomes

  1. AEs+SAEs

    Adverse Events and Serious Adverse Events

    Time frame: from the first drug administration to within 30 days for the last SHR-1210 dose

  2. PFS

    Progression-Free-Survival

    Time frame: up to 2 years

  3. ORR

    Objective Response Rate

    Time frame: At baseline,at the time point of every 8 weeks

  4. DCR

    Disease Control Rate

    Time frame: at the time point of every 8 weeks

  5. OS

    OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

    Time frame: up to 2 years

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Study locations

1 of 1 sites recruiting
  • Shandong Cancer Hospital and Institute
    Jinan, Shandong 250117, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03557411
Lead sponsor
Shandong Cancer Hospital and Institute
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Jinming Yu (Director of the hospital, Shandong Cancer Hospital and Institute) — Principal investigator
First posted
Jun 15, 2018
Start date
Jul 9, 2018
Primary completion
Jul 9, 2020 (estimated)
Completion
Jul 9, 2020 (estimated)
Last update
Feb 5, 2020

Study contacts

JINGMIN YU, PhD
Contact
jn7984729@public.jn.sd.cn
8613806406293 ext. 8653187984729
LIGANG XING, PhD
Contact
xinglg@medmail.com.cn
8618053100188 ext. 8653167626819
JINGMIN YU, PhD
principal investigator · Shandong Cancer Hospital and Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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