Clinical Trials /

Evaluate the Efficacy and Safety of IBI305 in Patients With Advanced or Recurrent Non-squamous NSCLC

NCT02954172

Description:

A randomized, double blind, multicenter phase3 study .

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

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Evaluate the Efficacy and Safety of IBI305 in Patients With Advanced or Recurrent Non-squamous NSCLC
  • Official Title: Study to Evaluate the Efficacy and Safety of IBI305 in Combination With Paclitaxel/Carboplatin Versus Bevacizumab in Combination With Paclitaxel/Carboplatin in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC

Clinical Trial IDs

  • ORG STUDY ID: CIBI305A301
  • NCT ID: NCT02954172

Conditions

  • NSCLC

Interventions

DrugSynonymsArms
Bevacizumab in combination with Paclitaxel/CarboplatinIBI305Bevacizumab in combination withPaclitaxel/Carboplatin
Avastin in combination with Paclitaxel/CarboplatinBevacizumabBevacizumab in combination withPaclitaxel/Carboplatin

Purpose

A randomized, double blind, multicenter phase3 study .

Detailed Description

      A randomized, double blind, multicenter phase3 study in chemotherapy naive patients with
      stage IIIB,IV or recurrent NSCLC of non-squamous. the study will randomize about 436 patients
      at a 1:1 ratio to 2 treatment arms. The study is divided 4 phase, screening, combination
      treatment, maintenance and follow up.
    

Trial Arms

NameTypeDescriptionInterventions
Bevacizumab in combination withPaclitaxel/CarboplatinExperimentalDrug Bevacizumab 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
  • Bevacizumab in combination with Paclitaxel/Carboplatin
  • Avastin in combination with Paclitaxel/Carboplatin
Avastin in combination with Paclitaxel/CarboplatinActive ComparatorDrug avastin15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
  • Bevacizumab in combination with Paclitaxel/Carboplatin
  • Avastin in combination with Paclitaxel/Carboplatin

Eligibility Criteria

        Inclusion Criteria:

          1. signed inform consent form(ICF)

          2. Age ≥ 18 years and ≤ 70 years, male or female

          3. Histologically or cytologically documented inoperable, local advanced (stage IIIB),
             metastatic (stage IV), or recurrent non-squamous NSCLC; Mixed tumors should be
             categorized according to the predominant cell type

          4. Histologically confirmed epidermal growth factor receptor (EGFR) wild type

          5. At least one measurable lesion according to Response Evaluation Criteria In Solid
             Tumors(RECISIT) v 1.1

          6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1

          7. Life expectancy ≥ 6 months

          8. Patients of childbearing potential must agree to use effective contraceptive measures
             during study treatment and for 6 months after receiving last study treatment (e.g.
             abstinence, sterilization surgery, oral contraceptives, contraception by progesterone
             injection or subcutaneous).

        Exclusion Criteria:

          1. Prior chemotherapy or target therapy with another systemic anti-cancer agent (e.g.,
             monoclonal antibody, tyrosine kinase inhibitor) for the treatment of the patient's
             current stage of disease (Stage IIIB not amenable for combined modality treatment,
             stage IV or recurrent disease). Prior surgery and irradiation is permitted, provided
             that the criteria outlined in the protocol for both treatments are met. Disease
             progressed within 6 months after adjuvant therapy must be excluded.

          2. Mixed non-small cell and small cell carcinoma, or mixed adenosquamous carcinomas with
             predominant squamous cell

          3. Histologically or cytologically confirmed EGFR mutation type, unknown EGFR status for
             any reason is allowed in this study.

          4. Known hemoptysis within 3 months prior to screening with blood volume more than 2.5 mL

          5. Evidence of tumor invading major blood vessels on imaging. The investigator or the
             local radiologist must exclude evidence of tumor that is fully contiguous with,
             surrounding, or extending into the lumen of a major blood vessel (e.g., pulmonary
             artery or superior vena cava)

          6. Evidence of brain metastasis, spinal cord compression or carcinomatous meningitis
             history, or confirmed brain metastasis by CT or MRI at baseline

          7. Radical radiotherapy to the thorax with curative intent within 28 days prior to
             enrollment; palliative radiotherapy for bone lesions outside the thoracic region
             within 2 weeks prior to first dose of study treatment.

          8. Serious, non-healing wound, active ulcer, or untreated bone fracture, or major
             surgical procedure within 28 days prior to randomization or anticipation of need for
             major surgery during the course of the study.

          9. Minor surgery (Including insertion of an indwelling catheter) within 48 hours prior to
             first dose of study treatment

         10. Recent or current receive treatment of Aspirin (> 325 mg/day) or other non-steroidal
             anti-inflammatory drugs (NSAID) known to inhibit platelet function (within 10 days
             prior to first dose of study treatment)

         11. Recent or current (within 10 days prior to first dose of study treatment) receive
             treatment of oral all doses of oral or parenteral anticoagulants or thrombolytic
             agent. Prophylactic use of anticoagulants is permitted.

         12. History or evidence of inherited bleeding diathesis or coagulopathy or thrombus

         13. Uncontrolled hypertension (SBP>150 mmHg and/or diastolic blood pressure>100 mmHg),
             prior history of hypertensive crisis and hypertensive encephalopathy

         14. Clinically significant cardiovascular disease but not limited to active infections;
             unstable angina; stroke or transient cerebral ischemia (within 6 months prior to
             screening); myocardial infarction (within 6 months prior to screening) ; congestive
             heart-failure (New York Heart Association (NYHA) class≥ II) ; serious cardiac
             arrhythmia, hepatic, renal or metabolic disease requiring medication during the study.

         15. History of peptic ulcer, gastrointestinal perforation, erosive esophagitis, erosive
             gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula or
             intra-abdominal abscess within 6 months prior to screening

         16. Patient diagnosed with a tracheo-esophageal fistula

         17. Clinically significant third space effusion (e.g., uncontrolled ascites or pleural
             effusion by extraction or other treatment)

         18. Pulmonary fibrosis or active pneumonia showed by CT at baseline

         19. Active malignancy other than non-small cell lung cancer (NSCLC), treated carcinoma in
             situ of the cervix, superficial basal cell or squamous cell carcinoma, radical surgery
             of localized prostate cancer, radical surgery of ductal carcinoma in situ within 5
             years prior to randomization

         20. Known autoimmune disease

         21. Known positive HbsAg and hepatitis B virus (HBV)-DNA drop test in peripheral blood ≥ 1
             x 103 copy number/L; If HBsAg positive and HBV-DNA drop test in peripheral blood < 1 x
             103 copy number/L, patient is considered to be eligible by investigator only when
             chronic hepatitis B in the plateau and do not increase the risk

         22. Known positive HIV or hepatitis C virus (HCV) or syphilis

         23. Known allergic disease or allergic physique

         24. Treatment with any other investigational agent or participation in another clinical
             trial within 30 days prior to screening

         25. Known alcoholism or drug abuse

         26. Pregnant or anticipation of pregnant during the study or lactating women

         27. Known hypersensitivity to bevacizumab or any of its excipients and/or any of the
             chemotherapy agents

         28. Other conditions that the investigator thinks unsuitable in this study
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:objective response rate
Time Frame:18 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:overall survival time
Time Frame:18 months
Safety Issue:
Description:
Measure:progression-free survival
Time Frame:18 months
Safety Issue:
Description:

Details

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

Last Updated

March 13, 2017