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Non-Small-Cell Lung CancerPhase 2NCT03557411

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

A Phase 2 study testing SHR-1210 in people with Non-Small-Cell Lung Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small-Cell Lung Cancer
What is being tested?
SHR-1210
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
9 Jul 2018to 9 Jul 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

JINGMIN YU, PhD contact

8613806406293 ext. 8653187984729

jn7984729@public.jn.sd.cn

LIGANG XING, PhD contact

8618053100188 ext. 8653167626819

xinglg@medmail.com.cn

China1 site, 1 recruiting

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong, 250117

    Jinming Yu, PhD, 13806406293, sdyujinming@126.com

    Xiangjiao Meng, PhD, 13793150996, mengxiangjiao@126.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
SHR-1210
Keywords
SHR-1210,radiotherapy,Oligometastases,NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1210Drug

    Also called Hypofraction Radiotherapy

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

Study groups in NCT03557411
Study groupRoleWhat they receive
SHR-1210 +Hypofraction radiotherapyExperimentalSHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy
Receives: Drug: SHR-1210

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinically significant toxicity

    above grade 3 AEs

    Measured: First cycle (28 days)

  2. 6-month-PFS

    6-month-progression free survival rate

    Measured: From the start of treatment to 6 months.

Secondary outcomes (5)

  1. AEs+SAEs

    Adverse Events and Serious Adverse Events

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

  2. PFS

    Progression-Free-Survival

    Measured: up to 2 years

  3. ORR

    Objective Response Rate

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

  4. DCR

    Disease Control Rate

    Measured: 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

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2018
  2. Study start9 Jul 2018
  3. Primary completion9 Jul 2020 (estimated)
  4. Study completion9 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
SHR-1210 Simultaneously Combined with Hypofraction Radiotherapy
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03557411
Sponsor's protocol ID
SHR-1210-RT-IIT-NSCLC-01
Status last verified
Feb 2020
First submitted
5 Jun 2018
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1210 in people with Non-Small-Cell Lung Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact JINGMIN YU, PhD (8613806406293 ext. 8653187984729, jn7984729@public.jn.sd.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically significant toxicity (time frame: First cycle (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03557411.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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