PD-1 Inhibitors Consolidation in Extensive-stage Small Cell Lung Cancer (PICARES)

June 2, 2019 updated by: Luhua Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Pilot Study on PD-1 Inhibitors Consolidation After Standard First-line Chemotherapy and Radiotherapy in Extensive-stage Small Cell Lung Cancer

The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received platinum-based chemotherapy and chest radiotherapy. 2-year survival rate of these patients is only about 10%. Therefore, this study aims to explore a comprehensive treatments with low toxicity to further improve the efficacy for these paitents with PD-1 inhibitor.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective pilot trial. The purpose of this study is to evaluate the safety and efficacy of PD-1 inhibitor consolidation in extensive-stage small cell lung cancer paitents who received standard first-line chemotherapy and chest radiotherapy ± SABR for metastasis disease.

The primary endpoint is the safety and objective response rate of treatment. The secondary objectives are progression free survival(PFS), overall survial. The exploratory end point includes the correlation of PD-1 expression on the tumor tissue, and the TMB, Immune Repertoire sequencing derived from the tumor tissue and the blood sample with the efficacy of treatent. The plan for collection of tumor tissue and blood at baseline at different stages during or after treatment was defined in the protocol.

The PICCARE-trial has been designed by National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, and the hypothesis is PD-1 inhibitor consolidation was safe and effective in the treatment of extensive-stage SCLC after sandard first-line chemotherapy and radiotherapy.

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sign written informed consent;
  • With extensive small cell lung cancer;
  • Previously received first-line standard chemotherapy, with treatment response of CR or PR;
  • Can provide at least 5-8 pathological tissue specimens (for detecting PD-L1 expression and infiltrating lymphocytes)
  • Can tolerate the radiotherapy process;
  • Weight ≥ 40kg;
  • Life expectancy ≥ 12 weeks;
  • With the Eastern Cancer Cooperative Group (ECOG) score 0-1;
  • The interval from the previous chemotherapy is more than 4 weeks, the grade of all adverse events caused by previous treatment have been reduced to grade 1 or less evaluated by CTCAE 4.03;
  • Before the administration of the study drug, systemic drugs (such as corticosteroids) applied at an immunosuppressive dose level (prednisone > 10 mg/d or equivalent) must have been discontinued for at least 2 weeks;
  • Major surgery requiring general anesthesia must have been completed for at least 4 weeks before administration of the study drug. Surgery requiring local anesthesia/epidural anesthesia must have been completed for at least 72 hours before administration of the study drug, and the subject must have recovered. Skin biopsy with only local anesthesia has been completed for at least 1 hour before administration of the study drug.
  • Other criteria including the laboratory values meets the requirements specified in the protocol.

Exclusion Criteria:

  • Subjects with central nervous system (CNS) metastases;
  • The subject has cancerous meningitis;
  • Subjects with active, known or suspected autoimmune diseases ;
  • Previously treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on the T cell stimulation or checkpoint pathway);
  • According to chest X-ray examination, sputum examination and clinical examination, it is determined that there is active tuberculosis (TB) infection now or before, even one year before;
  • A positive immunodeficiency virus (HIV) test or have acquired immunodeficiency syndrome (AIDS);
  • With comorbidity needs to be treated with an immunosuppressive drug;
  • Other research drugs were administrated 28 days prior to the start of study drug or although they were more than 28 days apart, still within the 5 half-life of previous study drugs;
  • Inoculated with any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before starting the study drug;
  • In the condition of pregnant or breastfeeding;
  • Inability to tolerate venous puncture and/or venous access;
  • Any other medical, psychotic, and/or social problems determined by the investigator;
  • Subject has interstitial lung disease;
  • Use any Chinese medicine with anti-tumor activity within 2 weeks before starting of the study drug;
  • Monoclonal antibodies have been used in the past 3 months, except for topical use;
  • Subjects who have previously had other malignancies (excluding non-melanoma skin cancer and the following carcinomas in situ: bladder, stomach, colon, endometrium, cervix/dysplasia, melanoma or breast cancer) are not allowed to participate in the study. Unless he/she has been cured at least 2 years prior to enrollment, and does not require additional treatment or other treatments during the study;
  • Subjects with chronic hepatitis B (hepatitis B surface antigen positive) or chronic hepatitis C (HCV antibody positive) blood screening positive;
  • Previously allergic to macromolecular protein preparations, or to any of the JS001 ingredients.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-1 inhibitor JS-001 consolidation for SCLC
The extensive-stage SCLC patients will receive PD-1 inhibitor JS-001 treatment after standard first-line chemotherapy, chest radiotherapy ± SABR for metastasis disease, and propylactic cranial irradiation untill disease progression or death.
Drug: PD-1 inhibitor JS-001
The extensive-stage SCLC patients will receive PD-1 inhibitor treatment after standard first-line chemotherapy, chest radiotherapy ± SABR for metastasis disease, and propylactic cranial irradiation untill disease progression or death.
Other Names:
  • SABR
  • radiotherapy
  • chemotherapy
  • propylactic cranial irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: At least 1 year following the conclusion of immunotherapy
The incidence and severity of adverse events related to treatments
At least 1 year following the conclusion of immunotherapy
Objective remission rate
Time Frame: 24 weeks following the conclusion of immunotherapy
Objective remission rate (ORR): refers to the proportion of subjects in the analyzed population who achieved complete remission (CR) or partial remission (PR); according to the tumor immunotherapy efficacy evaluation (irRC) and RECIST criteria (v1.1) by the evaluation of investigator.
24 weeks following the conclusion of immunotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamic indicators
Time Frame: During and 6 weeks after the treatment of immunotherapy
Pharmacodynamic indicators，such as the detection of PD-1 receptor occupancy in the blood
During and 6 weeks after the treatment of immunotherapy
Continuous remission time (DOR)
Time Frame: At least 1 year following the conclusion of immunotherapy
DOR was defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier
At least 1 year following the conclusion of immunotherapy
Disease Control Rate (DCR)
Time Frame: At least 1 year following the conclusion of immunotherapy
The percentage of patients who have achieved complete response, partial response and stable disease to the therapeutic intervention
At least 1 year following the conclusion of immunotherapy
Time to response (TTR)
Time Frame: 24 weeks following the conclusion of immunotherapy
The time from the start of treatment to the first objective tumor response
24 weeks following the conclusion of immunotherapy
Progression-free survival (PFS)
Time Frame: At least 1 year following the conclusion of immunotherapy
The length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse
At least 1 year following the conclusion of immunotherapy
Overall survival (OS)
Time Frame: At least 1 year following the conclusion of immunotherapy
The time from treatment to death from any cause
At least 1 year following the conclusion of immunotherapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory end point including biomarkers
Time Frame: At least 1 year following the conclusion of immunotherapy
To explore the correlation of PD-L1 expression in tumor tissue , TCR, ctDNA in peripheral blood and efficacy
At least 1 year following the conclusion of immunotherapy

Collaborators and Investigators

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Director: Nan Bi, MD, Cancer Hospital, CAMS and PUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 2, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC1835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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