Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC

April 29, 2020 updated by: Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China

Clinical Study on the Role of New Serum Tumor Autoantibodies in Predicting the Efficacy of Anti-PD-1 Immunotherapy in Patients With Advanced Non-small Cell Lung Cancer

PD-1/PD-L1 blockades have attracted much attention in the treatment of lung cancer, however only a small set of patients can benefit from this kind of immunotherapy. At present, the expression level of PD-L1 is the major factor to evaluate the prognosis，, which is highly dependent on the quality of tissue samples and detection methods.Therefore, finding predictive markers,especially based on liquid biopsy, to screen the patients who will benefit most from PD-1/PD-L1 blockades is an urgent issue in immunotherapy for lung cancer. Tumor autoantibodies, as immune response products of the immune system to tumor antigens, are of great significance in tumor diagnosis. Till now, the relationship between tumor autoantibodies and immunotherapy efficacy has not been reported. In this study, 200 non-small cell lung cancer patients will be enrolled with baseline serum tumor autoantibodies detection, then treated with PD-1 blockade. The purpose of this study is to explore the correlations of serum autoantibodies expression and efficacy of PD-1 inhibitor, so that to identify new markers for predicting the efficacy of PD-1/PD-L1 immunotherapy in non-small cell lung cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced non-small cell lung cancer, PD-L1 expression ≥1%, EGFR/ALK/ROS1 wild type will be studied. The serum autoantibodies will be detected before PD-1 blockade treatment.

Description

Inclusion Criteria:

  1. The subjects understood the requirements and risks of the study fully and signed the informed consent form.
  2. Aged between 18 and 70 years;
  3. Histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer.
  4. Immunohistochemistry of pathological tissue: PD-L1 (22C3) ≥ 1%,Gene detection EGFR (-); ALK (-), ROS1 (-).
  5. All of these patients have no surgical indications or radical radiotherapy guidelines.
  6. ECOG PS score 0-1, life expectancy not less than 12 weeks.
  7. According to RECIST1.1,there is at least one tumor site that can be accurately measured by CT in patients.
  8. Women of childbearing age had negative pregnancy tests and were willing to accept drugs or intrauterine contraception, while men of childbearing age were willing to accept contraception voluntarily.
  9. Adequate hematologic function:Peripheral blood neutrophil count > 2000 cells / uL, Platelet count > 100*109 / L; Hemoglobin >9.0g/dL;Blood total bilirubin < 2 times normal upper limit, blood AST and ALT ≤ 2. 5 times normal upper line;Inosine clearance ≥ 60ml / min.

Exclusion Criteria:

  1. Subjects who needed to receive systemic corticosteroids (prednisone equal to or higher than 10mg / day) or other immunosuppressive drugs within 14 days before enrollment or during the study.
  2. Subjects who had been vaccinated with antineoplastic vaccine or received antineoplastic drugs with immunostimulatory effect within 4 weeks before entering the group.
  3. Subjects with known or suspected active autoimmune diseases (vitiligo, type I diabetes, autoimmune thyroiditis requiring hormone replacement therapy, and other autoimmune diseases without recurrence can also be included).
  4. Subjects with other tumors in the past 5 years, except cervical carcinoma in situ, basal cell carcinoma of the skin, etc.
  5. Subjects with any unstable systemic diseases (including active infections, poorly controlled hypertension, unstable angina pectoris, angina pectoris that occurred in the past 3 months, congestive heart failure (or New York Heart Association (NYHA) II)), infarcts (within 6 months), severe arrhythmias requiring medication, liver, kidney or metabolic diseases.
  6. Subjects with previous or present interstitial lung diseases.
  7. Subjects with systemic infection who need to be treated, HBV surface antigen positive or HCV RNA positive; patients who have previously or currently detected human immunodeficiency virus (HIV) or AIDS.
  8. Subjects who received targeted therapy or biotherapy at the same time.
  9. Subjects who are allergic to therapeutic drugs (chemotherapeutic drugs and immune drugs);
  10. Subjects who underwent major surgery or suffered severe trauma within 2 months before the first treatment;
  11. Situations that other researchers do not consider appropriate to be included.
  12. Subjects whose expected survival time is less than 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study group
All participants will be detected for antoantibodies and then treated with PD-1 blockade.
Diagnostic test: Serum tumor autoantibody detection
All enrolled patients will be tested for ten kinds of tumor autoantibodies using peripheral blood before PD-1 bloackade treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The correlations of tumor autoantibodies and PFS/ORR of PD-1 blockade treatment.
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
To analyze the relationships of serum tumor autoantibody expression and PFS (progression-free survival) and ORR ( objective response rate) of enrolled patients treated with PD-1 blockade.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The correlations of tumor autoantibodies and OS/DCR of PD-1 blockade treatment.
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
To analyze the relationships of serum tumor autoantibody expression and OS (overall survival) and DCR (disease control rate) of enrolled patients treated with PD-1 blockade.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K20-188

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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