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

NCT03971214 | Unknown Phase 1 DMC

• 1 other identifier: NCC1835
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extensive-stage Small Cell Lung Cancer; Radiotherapy; Immunotherapy

Keywords

small cell lung cancer; radiotherapy; PD-1 inhibitor

Outcome Measures

Primary Outcomes (2)

• Adverse events

  The incidence and severity of adverse events related to treatments

  At least 1 year following the conclusion of immunotherapy

• Objective remission rate

  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 Outcomes (6)

• Pharmacodynamic indicators

  During and 6 weeks after the treatment of immunotherapy

• Continuous remission time (DOR)

  At least 1 year following the conclusion of immunotherapy

• Disease Control Rate (DCR)

  At least 1 year following the conclusion of immunotherapy

• Time to response (TTR)

  24 weeks following the conclusion of immunotherapy

• Progression-free survival (PFS)

  At least 1 year following the conclusion of immunotherapy

Other Outcomes (1)

• Exploratory end point including biomarkers

  At least 1 year following the conclusion of immunotherapy

Study Arms (1)

PD-1 inhibitor JS-001 consolidation for SCLC

EXPERIMENTAL

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

Interventions

PD-1 inhibitor JS-001 DRUG

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.

Also known as: chemotherapy, radiotherapy, SABR, propylactic cranial irradiation

PD-1 inhibitor JS-001 consolidation for SCLC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

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MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nan Bi, MD

  Cancer Hospital, CAMS and PUMC

  STUDY DIRECTOR

Central Study Contacts

Wen-Yang Liu, MD

CONTACT

8613810753633; liuwenyang26@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 3, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: June 4, 2019

Record last verified: 2019-06

Locations

CN (1)