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

NCT02954172 | Completed Phase 3 Results

• 1 other identifier: CIBI305A301
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double blind, multicenter phase3 study .

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  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.

  18 weeks

Secondary Outcomes (2)

• Overall Survival Time

  18.020 months

• Progression-free Survival

  18 months

Study Arms (2)

Bevacizumab in Combination With Paclitaxel/Carboplatin

EXPERIMENTAL

Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg

Drug: Bevacizumab in Combination With Paclitaxel/Carboplatin

IBI305 in Combination with Paclitaxel/Carboplatin

ACTIVE COMPARATOR

Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg

Drug: IBI305 in Combination with Paclitaxel/Carboplatin

Interventions

Bevacizumab in Combination With Paclitaxel/Carboplatin DRUG

Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg

Also known as: Avastin

Bevacizumab in Combination With Paclitaxel/Carboplatin

IBI305 in Combination with Paclitaxel/Carboplatin DRUG

Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg

Also known as: Bevacizumab Biosimilar

IBI305 in Combination with Paclitaxel/Carboplatin

Eligibility Criteria

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

You may qualify if:

• signed inform consent form(ICF)
• Age ≥ 18 years and ≤ 75 years, male or female
• 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
• Histologically confirmed epidermal growth factor receptor (EGFR) wild type or insensitive mutation
• At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
• Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
• Life expectancy ≥ 6 months
• Laboratory results:
• Adequate hematologic function, defined as absolute neutrophil count ≥1.5×10\^9 /L, platelet count ≥100 ×10\^9 /L, hemoglobin ≥90g/L;
• 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;
• Adequate renal function, defined as serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 ml / min (Cockcroft-Gault formula) and proteinuria \< 2+;
• 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;
• Expected protocol compliance
• 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).

You may not qualify if:

• 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.
• Mixed non-small cell and small cell carcinoma, or mixed adenosquamous carcinomas with predominant squamous cell
• Histologically or cytologically confirmed EGFR sensitive mutation type, unknown EGFR status for any reason is allowed in this study.
• Known hemoptysis within 3 months prior to screening with blood volume more than 2.5 mL each time
• 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)
• 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.
• 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.
• 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.
• Minor surgery (Including insertion of an indwelling catheter) within 48 hours prior to first dose of study treatment
• 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)
• Recent or current receive treatment of oral all doses of oral or parenteral anticoagulants or thrombolytic agent. Prophylactic use of anticoagulants is permitted.
• History or evidence of inherited bleeding diathesis or coagulopathy or thrombus
• Uncontrolled hypertension (SBP\>140 mmHg and/or diastolic blood pressure\>90 mmHg), prior history of hypertensive crisis and hypertensive encephalopathy
• 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.
• 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

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead
• WuXi CDS Clinical Research (Shanghai) Co.Ltd.: collaborator

Study Sites (1)

Cancer Center; Sun Yat sen University;

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Yang Y, Wu B, Huang L, Shi M, Liu Y, Zhao Y, Wang L, Lu S, Chen G, Li B, Xie C, Fang J, Yang N, Zhang Y, Cui J, Song Y, Zhang C, Mei X, Cao B, Yang L, Cheng Y, Ying K, Sun T, Ren B, Yu Q, Liao Z, Pei Z, Wang M, Zhou J, Yu S, Feng G, Wan H, Wang H, Gao S, Wang J, An G, Geng Y, Ji Y, Yuan Y, Ma S, Jia Z, Hu M, Zhou H, Yu J, Sun X, Zhang L. Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer. Transl Lung Cancer Res. 2019 Dec;8(6):989-999. doi: 10.21037/tlcr.2019.12.23.

  PMID: 32010577 DERIVED

MeSH Terms

Interventions

Bevacizumab; Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Yi Bo
• Organization: Innovent Biologics (Suzhou) Co., Ltd. (seal)

jessica.yi@innoventbio.com

+86 13382419112

Study Officials

• Li Zhang, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2016
• First Posted: November 3, 2016
• Study Start: November 28, 2016
• Primary Completion: October 19, 2018
• Study Completion: November 12, 2019
• Last Updated: December 8, 2020
• Results First Posted: December 8, 2020

Record last verified: 2020-11

Locations

CN (1)