Clinical Trials /

A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC

NCT03150875

Description:

Similar clinical trial results demonstrated that anti-PD-1 antibodies prolonged OS to approximately 9 months compared with 6 months in docetaxel group. Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial. Additionally the correlation between PD-L1 expression and the response to IBI308 treatment in Chinese squamous cell NSCLC as well as the role of irRECIST in immune checkpoint inhibitor treatment evaluation will also be assessed

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

Unknown status

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC
  • Official Title: Efficacy and Safety Evaluation of IBI308 Versus Docetaxel in Patients With Advanced or Metastatic Squamous Cell Lung Cancer After Failure of First-line Platinum-based Therapy- a Randomized, Open-label, Multicenter, Parallel, Phase 3 Study (ORIENT-3)

Clinical Trial IDs

  • ORG STUDY ID: CIBI308C301
  • NCT ID: NCT03150875

Conditions

  • Squamous Cell Lung Carcinoma

Interventions

DrugSynonymsArms
IBI308IBI308
Docetaxeldocetaxel

Purpose

Similar clinical trial results demonstrated that anti-PD-1 antibodies prolonged OS to approximately 9 months compared with 6 months in docetaxel group. Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial. Additionally the correlation between PD-L1 expression and the response to IBI308 treatment in Chinese squamous cell NSCLC as well as the role of irRECIST in immune checkpoint inhibitor treatment evaluation will also be assessed

Trial Arms

NameTypeDescriptionInterventions
IBI308Experimentalinjection; dosage form: 10ml:100mg; frequency: 200mgQ3W; duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria
    docetaxelActive Comparatorinjection; dosage form: 1ml:40mg; Frequency: 75mg/m2 Q3W; duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria
    • Docetaxel

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Subjects with Histologically or cytologically confirmed squamous cell NSCLC
    
              2. Subjects with stage IIIB/stage IV or recurrent disease (not suitable for definitive
                 concurrent chemoradiotherapy) (according to version 7 of the International Association
                 for the Study of Lung Cancer Staging Manual in Thoracic Oncology) after failure of
                 first-line platinum-based therapy; Subjects who developed recurrent disease <6 months
                 after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy
                 also could also be eligible.
    
              3. At lease one measurable disease according to Response Evaluation Criteria In Solid
                 Tumors (RECIST) 1.1
    
              4. Age ≥ 18 and ≤ 75
    
              5. ECOG performance status 0-1
    
              6. Life expectancy of at least 12 weeks
    
              7. Adequate organ and bone marrow function
    
                   1. CBC: absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelet count (PLT) ≥ 100
                      × 109 / L; hemoglobin content (HGB) ≥ 9.0 g / dL.
    
                   2. Liver function: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN);
                      alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
                      serum albumin ≥ 28 g / L.
    
                   3. Renal function: serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate
                      (Ccr) ≥ 40 mL / min (calculated using Cockcroft / Gault equation) Female:CrCl=
                      (140-Age) x Weight(kg) x 0.85 72 x Serum creatinine (mg/dL) Male:CrCl= (140-Age)
                      x Weight(kg) x 1.00 72 x Serum creatinine (mg/dL)
    
              8. Subjects of reproductive potential must be willing to use adequate contraception
                 during the course of the study and through 6 months after the last dose of study
                 treatment.
    
              9. Voluntarily signed written informed consent form, willing and able to comply with
                 scheduled visits and other requirements of the study
    
            Exclusion Criteria:
    
              1. EGFR mutation and ALK rearrangement
    
              2. Mixed adeno-squamous carcinoma or other pathological type
    
              3. Prior therapy with anti-PD-1,anti-PD-L1,anti-CTLA4 antibody or docetaxel
    
              4. Have received following treatment:
    
                   1. Received any investigational agent within 4 weeks of the first dose of study
                      treatment.
    
                   2. Received any anti-tumor therapy (chemotherapy, targeted therapy, tumor
                      immunotherapy or arterial embolization) within 3 weeks of the first dose of study
                      treatment.
    
                   3. Received radiotherapy within 4 weeks of the first dose of study treatment.
    
                   4. Received systemic treatment with high-dose corticosteroids (> 10 mg daily
                      prednisone equivalent) or other immunosuppressive drugs within 4 weeks of first
                      dose. Inhaled or topical steroids and adrenal replacement steroid are permitted
                      in the absence of active autoimmune disease.
    
                   5. Received attenuated live vaccine within 4 weeks of the first dose of study
                      medication or plan to receive live vaccine during study period.
    
                   6. Received major surgery (such as craniotomy, thoracotomy or laparotomy) within 4
                      weeks of the first dose of study drugs or open wound, ulcer or fracture.
    
              5. Unrecovered toxicity (grade >1, according to NCI CTCAE 4.03) due to prior anti-tumor
                 therapy before the first dose of study treatment.
    
              6. Subjects with active, known or suspected autoimmune disease such as interstitial
                 pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured
                 childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone
                 replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not
                 requiring systemic treatment.
    
              7. Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation
    
              8. Known allergic or hypersensitive to docetaxel, any monoclonal antibody or any other
                 components used in their preparation.
    
              9. Hemoptysis within 4 weeks of randomization (≥ 1/2 spoon per time).
    
             10. Received thoracic radiotherapy >30Gy within 6 months or palliative radiotherapy (brain
                 or bone metastasis) ≤30Gy within 7 days of randomization.
    
             11. Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis.
                 Subjects should have stable disease more than 4 weeks from first dose of study
                 treatment, with neurological symptoms returned to NCI CTCAE 4.03 grade 0 or 1, are
                 permitted to enroll.
    
             12. Subjects with a history of interstitial lung disease
    
             13. Superior vena caval obstruction syndrome;
    
             14. Uncontrolled third space effusion, eg. ascites or pleural effusion.
    
             15. Uncontrolled concomitant disease, including but not limited to :
    
                   1. Active or poorly controlled severe infection
    
                   2. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive)
    
                   3. Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute
                      or chronic active hepatitis C (HCV antibody positive and HCV RNA positive)
                      infection
    
                   4. Active tuberculosis
    
                   5. Symptomatic congestive heart failure (New York Heart Association grade III-IV) or
                      symptomatic, poorly controlled arrhythmia
    
                   6. Uncontrolled hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg)
    
                   7. Prior arterial thromboembolism event, including myocardial infarction, unstable
                      angina, stroke and transient ischemic attack, within 6 months of enrollment
    
                   8. Concomitant disease needs anticoagulant therapy
    
                   9. Uncontrolled hypercalcemia(Ca2+>1.5mmol/L or Ca >12mg/dl or corrected Serum
                      Calcium >ULN),or Symptomatic hypercalcemia during diphosphonate therapy
    
                  10. Other primary malignancy, with the exception of: (radical Non-melanoma skin
                      cancer or cured cervical in-situ carcinoma;)
    
             16. Subjects with other diseases or abnormal Lab test results which might increase the
                 risk of enrollment and treatment or Interfere with the interpretation of study results
                 could be excluded according to the judgments of investigator.
    
             17. Women who are pregnant or nursing
          
    Maximum Eligible Age:75 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:OS (overall survival)
    Time Frame:up to 24 months after randomization
    Safety Issue:
    Description:OS was defined as the time between the date of randomization and the date of death from any cause.

    Secondary Outcome Measures

    Measure:PFS (progression free survival)
    Time Frame:up to 24 months after randomization]
    Safety Issue:
    Description:PFS was defined as the time from the date of randomization to the date of the first documented tumor progression per RECIST v1.1 criteria
    Measure:ORR(objective response rate)
    Time Frame:up to 24 months after randomization
    Safety Issue:
    Description:Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment(per RECIST v1.1).
    Measure:DOR(Duration of objective response)
    Time Frame:up to 24 months after randomization
    Safety Issue:
    Description:DOR is defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1)
    Measure:DCR(Disease control rate)
    Time Frame:up to 24 months after randomization
    Safety Issue:
    Description:DOR is defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1)
    Measure:AEs
    Time Frame:up to 24 months after screening
    Safety Issue:
    Description:Number of participants with treatment-related adverse events (AEs)

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Innovent Biologics (Suzhou) Co. Ltd.

    Last Updated

    November 29, 2017