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OpenTrials
Completed

NCT Number: NCT05169801

To Compare the Efficacy and Safety of BP102 vs. Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC

This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged from 18 to 75 (including 18 and 75), male or female;
  • Patients with locally advanced and unresectable NSCLC that has been histologically or cytologically proven, metastatic, or recurrent NSCLC.
  • No previous systematic antitumor therapy for current stage diseases. If previous adjuvant therapy has been received, it is necessary to ensure that the interval between the end of adjuvant therapy and the first administration of this study is more than 6 months, and that all adjuvant treating-related toxic reactions have recovered.
  • Patients must be able to document the EGFR mutation and ALK fusion gene status, and ALK must be negative. Patients who have not previously been tested for EGFR and ALK genes should be tested during screening;
  • There must be at least one measurable lesion as a target (according to RECIST V1.1);
  • ECOG: 0~1;
  • Life expectancy ≥24 weeks;
  • Major organs' function well.

Exclusion criteria

  • Patients with non-small cell lung cancer of other pathological tissue types;
  • Tumor histology or cytology confirmed positive ALK fusion gene;
  • Patients with imaging evidence of tumor invasion of large blood vessels;
  • Patients with uncontrolled pleural effusion and pericardial effusion that require repeated drainage;
  • Patients with abdominal effusion;
  • During the screening period, chest CT showed tumor cavity formation, or CT scan was highly suspected of idiopathic pulmonary fibrosis, mechanized pneumonia, drug-associated pneumonia, idiopathic pneumonia or active pneumonia;
  • Patients with hypertension whose blood pressure has not been satisfactorily controlled by antihypertensive drugs, and patients with previous hypertensive crisis or hypertensive encephalopathy;
  • Have heart disease or clinical symptoms that are not well controlled;
  • Patients with unhealed wounds, active gastric ulcers or fractures;
  • Patients diagnosed with esophagotracheal fistula;
  • People with known hereditary bleeding tendency or coagulation disorder;
  • Patients with known central nervous system metastases.

Treatment and study plan

BP102, paclitaxel, carboplatin

Drug

BP102, paclitaxel, carboplatin

Avastin®, paclitaxel, carboplatin

Drug

Avastin®, paclitaxel, carboplatin

Primary outcomes

  1. Objective response rate

    Time frame: 18 weeks

    optimal ORR at 18 weeks, independent radiographic assessment

Secondary outcomes

  1. Progression-free survival

    Time frame: 41 months

    Progression-free survival is the time from randomization to the first documented objective disease progression (PD) using RECIST v1.1 or death due to any cause, whichever occurs first.

  2. Overall survival (OS)

    Time frame: 41 months

    Overall survival is defined as the time from day 1 (part 1) or from randomization (part 2) to date of death.

  3. Disease Control Rate (DCR)

    Time frame: 41 months

    Based on investigator reviewed radiographic tumour assessment and death.

  4. Duration of Response (DoR)

    Time frame: 41 months

    Based on investigator reviewed radiographic tumour assessment and death.

  5. Quality of Life assessment using EORTC QLQ-C30

    Time frame: 41 months

    Evaluate subjects' quality of life

  6. Incidence of treatment-emergent adverse events, serious adverse events

    Time frame: Enrollment to 28 days after permanent treatment termination

    Safety analyses will be performed using the safety population, defined as all patients receiving any study drug.

  7. Positive rate of anti-bevacizumab antibody and its titer

    Time frame: 41 months

    Immunogenicity evaluation

  8. Positive rate of neutralizing antibody

    Time frame: 41 months

    Immunogenicity evaluation

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

To Compare the Efficacy and Safety of BP102 in Combination With Paclitaxel/Carboplatin and Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC - a Randomized, Double-blind, Positive Parallel Control, Multicentre Phase III Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Dec 27, 2021
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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