Clinical Trials /

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



A randomized, double blind, multicenter phase3 study .

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



Phase 3

Trial Eligibility



  • 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

  • NCT ID: NCT02954172




Bevacizumab in Combination With Paclitaxel/CarboplatinAvastinBevacizumab in Combination With Paclitaxel/Carboplatin
IBI305 in Combination with Paclitaxel/CarboplatinBevacizumab BiosimilarIBI305 in Combination with Paclitaxel/Carboplatin


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

Bevacizumab in Combination With Paclitaxel/CarboplatinExperimentalDrug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
  • Bevacizumab in Combination With Paclitaxel/Carboplatin
IBI305 in Combination with Paclitaxel/CarboplatinActive ComparatorDrug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
  • IBI305 in Combination with Paclitaxel/Carboplatin

Eligibility Criteria

        Inclusion Criteria:

          1. signed inform consent form(ICF)

          2. Age ≥ 18 years and ≤ 75 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 or
             insensitive mutation

          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. Laboratory results:

               1. Adequate hematologic function, defined as absolute neutrophil count ≥1.5×10^9 /L,
                  platelet count ≥100 ×10^9 /L, hemoglobin ≥90g/L;

               2. Adequate liver function, defined as total bilirubin levels ≤ 1.5 times normal
                  upper limit (ULN), and aspartate aminotransferase (AST) and alanine
                  aminotransferase (ALT) levels ≤ 2.5 times ULN, or AST and ALT levels ≤ 5 times
                  ULN for patients with hepatic metastasis;

               3. Adequate renal function, defined as serum creatinine ≤ 1.5 times ULN or
                  creatinine clearance ≥ 50 ml / min (Cockcroft-Gault formula) and proteinuria <

               4. Coagulation function is adequate, defined as international normalized ratio (INR)
                  or prothrombin time (PT) ≤ 1.5 times normal upper limit (ULN), PTT or aPTT ≤ 1.5
                  times ULN;

          9. Expected protocol compliance

         10. 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 sensitive 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
             each time

          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 with clinical symptoms. For stable patients with no symptom, could be admitted
             if fulfill all below criteria: measurable lesion(s) out of CNS, no metastasis at
             mesocephalon, annular protuberance, medulla oblongata and spinal cord; no history of
             intracranial bleeding.

          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 (within 10 days prior to first dose of study treatment) 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 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>140 mmHg and/or diastolic blood pressure>90 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 10^3 copy number/L or 200 IU/mL; If HBsAg positive and HBV-DNA drop test in
             peripheral blood < 1 x 10^3 copy number/L or 200 IU/mL, 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:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate
Time Frame:18 weeks
Safety Issue:
Description:ORR(objective response rate)was defined as the percentage of participants in the analysis population who had a Complete Response or a Partial Response per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented. Overall Response (OR) = CR + PR.

Secondary Outcome Measures

Measure:Overall Survival Time
Time Frame:18.020 months
Safety Issue:
Description:OS was defined as the time from randomization to death due to any cause.
Measure:Progression-free Survival
Time Frame:18 months
Safety Issue:
Description:Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Independent Radiological Review Committee.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions


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

Last Updated

December 8, 2020