Clinical Trials /

Toripalimab as Maintenance Therapy in Patients With Driver-gene Negative Advanced NSCLC After First-line Chemotherapy

NCT04613804

Description:

Lung cancer is the malignant tumor with the highest incidence and mortality in China. Non-small cell lung cancer (NSCLC) ,which includes non-squamous cell carcinoma (including adenocarcinoma, large cell carcinoma, and other cell types) and squamous cell carcinoma, accounts for about 80% of lung cancer. Platinum-based two-drug chemotherapy is the first-line standard treatment for driver-gene negative advanced NSCLC, but most patients experience disease progression after 4 to 6 months. To extend the efficacy of first-line treatment, maintenance therapy is a logical clinical option for patients who are effective after 4 to 6 cycles of standard treatment. There is currently no standard regimen for maintenance treatment of NSCLC. We evaluated the effectiveness and safety of maintenance therapy with the anti-PD-1 monoclonal antibody (Toripalimab injection) followed by the first-line standard regimen in advanced NSCLC patients who are effective after standard treatment. With a view to exploring treatment methods that are effective for the maintenance treatment of driver-gene negative advanced NSCLC and have little toxic and side effects,thereby improving the survival prognosis of these patients.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Toripalimab as Maintenance Therapy in Patients With Driver-gene Negative Advanced NSCLC After First-line Chemotherapy
  • Official Title: Toripalimab as Maintenance Therapy in Patients With Driver-gene Negative Advanced NSCLC After First-line Chemotherapy :a Single-arm Phase II Trial

Clinical Trial IDs

  • ORG STUDY ID: SCOG001
  • NCT ID: NCT04613804

Conditions

  • NSCLC Stage IV

Interventions

DrugSynonymsArms
Toripalimab InjectionPD-1 inhibitorToripalimab group

Purpose

Lung cancer is the malignant tumor with the highest incidence and mortality in China. Non-small cell lung cancer (NSCLC) ,which includes non-squamous cell carcinoma (including adenocarcinoma, large cell carcinoma, and other cell types) and squamous cell carcinoma, accounts for about 80% of lung cancer. Platinum-based two-drug chemotherapy is the first-line standard treatment for driver-gene negative advanced NSCLC, but most patients experience disease progression after 4 to 6 months. To extend the efficacy of first-line treatment, maintenance therapy is a logical clinical option for patients who are effective after 4 to 6 cycles of standard treatment. There is currently no standard regimen for maintenance treatment of NSCLC. We evaluated the effectiveness and safety of maintenance therapy with the anti-PD-1 monoclonal antibody (Toripalimab injection) followed by the first-line standard regimen in advanced NSCLC patients who are effective after standard treatment. With a view to exploring treatment methods that are effective for the maintenance treatment of driver-gene negative advanced NSCLC and have little toxic and side effects,thereby improving the survival prognosis of these patients.

Detailed Description

      Platinum-based two-drug chemotherapy is the first-line standard treatment for driver-negative
      advanced NSCLC, but most patients experience disease progression after 4 to 6 months. To
      extend the efficacy of first-line treatment, maintenance therapy is a logical clinical option
      for patients who are effective after 4 to 6 cycles of standard treatment. There is currently
      no standard regimen for maintenance treatment of NSCLC. We evaluated the effectiveness and
      safety of the anti-PD-1 monoclonal antibody (Toripalimab injection) followed by maintenance
      therapy in advanced NSCLC that was effective in the first-line standard regimen.Thereby
      improving the survival prognosis of advanced NSCLC.
    

Trial Arms

NameTypeDescriptionInterventions
Toripalimab groupExperimentalToripalimab 240mg ivgtt Q21d
  • Toripalimab Injection

Eligibility Criteria

        Criteria:

        Inclusion Criteria:

          -  Fully understand the research and voluntarily sign the informed consent form (ICF)

          -  Age 18 to 75 years

          -  Histological or cytological documentation of non-small cell lung cance.

          -  Diagnosed as stage IV by imaging (staging according to AJCC eighth edition).

          -  Gene test is negative for EGFR, ALK, ROS1 confirmed by molecular pathology (tissue,
             ARMS method or NGS).

          -  Previously received first-line standard chemotherapy for non-small cell lung cancer
             (platinum combined with third-generation chemotherapy drugs in a two-drug combination
             regimen: pemetrexed or paclitaxel or docetaxel or gemcitabine or vinorelbine combined
             with cisplatin or carboplatin), and which were assessed the effectiveness by
             imaging(SD, PR or CR).

          -  At least one measurable lesion according to Response Evaluation Criteria in Solid
             Tumors (RECIST) criteria measured within 4 weeks prior to registration.

          -  ECOG performance status 0-1

          -  Expected overall survival time≥3 months

          -  Adequate bone marrow, Coagulation function,hepatic and renal function should be
             assessed by the following laboratory requirements conducted within 7 days before
             starting study treatment:

               -  Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet
                  count ≥ 100 x109/ L, hemoglobin (Hb) ≥9g/ dL.

               -  Total bilirubin ≤ 1.5 x the upper limit of normal (ULN).

               -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN.

               -  Serum creatinine ≤ 1.5 x the ULN.

               -  Calculated creatinine clearance or 24 hour creatinine clearance ≥ 40 mL/ min.

               -  INR≤1.5, Activated partial thromboplastin time(APTT)≤1.5×ULN.

          -  Patients with hepatitis B virus (HBV) infection and inactive/asymptomatic HBV
             carriers, or patients with chronic or active HBV, if the HBV DNA is <500IU/ml, or
             2500copies/ml at the time of screening,can enter the group.

          -  Male subjects and women of childbearing age must have contraception within 24 weeks
             from the start of the study to the last time of using the drug.

        Exclusion Criteria:

          -  Tumor histology or cytology pathology confirmed with small cell lung cancer components
             or sarcomatoid lesions.

          -  Previously received any T-cell co-stimulation or immune checkpoint therapy, including
             but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 / 2 inhibitors or other
             drugs that target T cells.

          -  Major autoimmune diseases.

          -  Subjects who were vaccinated or planned to be vaccinated within 4 weeks before the
             first time using the study drug.

          -  LD, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or
             clinically active pneumonia or severe pulmonary dysfunction.

          -  TB or subjects with a history of active tuberculosis infection ≤ 48 weeks before
             screening, whether or not treated.

          -  Symptomatic cardiac disease, such as: heart failure above NYHA level 2, unstable
             angina pectoris, myocardial infarction occurred within 24 weeks, clinically
             significant supraventricular or ventricular arrhythmias require treatment or
             intervention.

          -  Acquired immunosuppression (AIDS or major immunosuppressive agents)

          -  Suffering from active viral hepatitis. Defined as: Hepatitis B virus (HBV) infection
             and HBV DNA ≥ 2500 copies / ml; or Hepatitis C virus (HCV) infection (quantitative
             test results of anti-HCV positive and HCV RNA are greater than the lower limit of
             detection) .

          -  Mental illness, alcohol, drug or substance abuse

          -  Pregnant or lactating women.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:up to 12 months
Safety Issue:
Description:PFS by investigator-reported measurements according to CT image. PFS was calculated from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.PD was defined as Overall Response by RECIST criteria v1.1 according to CT image.

Secondary Outcome Measures

Measure:Overall survival time
Time Frame:Up to 36 months
Safety Issue:
Description:OS was calculated from the date of randomization to death from any cause.
Measure:Objective response rate
Time Frame:up to 12 months
Safety Issue:
Description:CR + PR rate according to the RECIST version 1.1 guidelines.
Measure:Disease control rate
Time Frame:up to 12 months
Safety Issue:
Description:CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Measure:Adverse events rate
Time Frame:up to 12 months
Safety Issue:
Description:Adverse events were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Fujian Cancer Hospital

Trial Keywords

  • driver-gene negative advanced NSCLC
  • maintenance treatment

Last Updated

November 1, 2020