Non-small Cell Lung Cancer(NSCLC)Phase 3NCT05169801

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

A Phase 3 study testing BP102, paclitaxel, carboplatin and Avastin®, paclitaxel, carboplatin in people with Non-small Cell Lung Cancer(NSCLC), run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-small Cell Lung Cancer(NSCLC)
What is being tested?: BP102, paclitaxel, carboplatin and Avastin®, paclitaxel, carboplatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 520 participants
Where: 1 siteChina
Study dates: 25 Jan 2018to 17 Jun 2021
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official 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

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.

Conditions: Non-small Cell Lung Cancer(NSCLC)
Being tested: BP102, paclitaxel, carboplatin, Avastin®, paclitaxel, carboplatin
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BP102, paclitaxel, carboplatinDrug
BP102, paclitaxel, carboplatin
Avastin®, paclitaxel, carboplatinDrug
Avastin®, paclitaxel, carboplatin

Study groups in NCT05169801
Study group	Role	What they receive
Treatment group A	Experimental	Not described Receives: Drug: BP102, paclitaxel, carboplatin
Treatment group B	Active comparator	Not described Receives: Drug: Avastin®, paclitaxel, carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective response rate
optimal ORR at 18 weeks, independent radiographic assessment
Measured: 18 weeks

Secondary outcomes (8)

Progression-free survival
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.
Measured: 41 months
Overall survival (OS)
Overall survival is defined as the time from day 1 (part 1) or from randomization (part 2) to date of death.
Measured: 41 months
Disease Control Rate (DCR)
Based on investigator reviewed radiographic tumour assessment and death.
Measured: 41 months
Duration of Response (DoR)
Based on investigator reviewed radiographic tumour assessment and death.
Measured: 41 months
Quality of Life assessment using EORTC QLQ-C30
Evaluate subjects' quality of life
Measured: 41 months
Incidence of treatment-emergent adverse events, serious adverse events
Safety analyses will be performed using the safety population, defined as all patients receiving any study drug.
Measured: Enrollment to 28 days after permanent treatment termination
Positive rate of anti-bevacizumab antibody and its titer
Immunogenicity evaluation
Measured: 41 months
Positive rate of neutralizing antibody
Immunogenicity evaluation
Measured: 41 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 201817 Jun 2021

First posted27 Dec 2021
Study start25 Jan 2018
Primary completion21 Oct 2019
Study completion17 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-small Cell Lung Cancer(NSCLC)Studies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: BP102 in combination with paclitaxel/carboplatin compared with Avastin® in combination with paclitaxel/carboplatin
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 520 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05169801
Sponsor's protocol ID: HR-BP102-III-NSCLC
Status last verified: Dec 2021
First submitted: 23 Dec 2021
Last updated: 27 Dec 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Non-small Cell Lung Cancer(NSCLC) trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05169801
Acronym / sponsor ID: HR-BP102-III-NSCLC
Conditions: Non-small Cell Lung Cancer(NSCLC)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 520 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Jan 2018 (actual)
Primary completion: 21 Oct 2019 (actual)
Study completion: 17 Jun 2021 (actual)
First posted: 27 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: BP102 in combination with paclitaxel/carboplatin compared with Avastin® in combination with paclitaxel/carboplatin

Arm	Type	Receives
Treatment group A	Experimental	Drug: BP102, paclitaxel, carboplatin
Treatment group B	Active comparator	Drug: Avastin®, paclitaxel, carboplatin

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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);

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BP102, paclitaxel, carboplatinBP102, paclitaxel, carboplatin	Drug	Treatment group A
Avastin®, paclitaxel, carboplatinAvastin®, paclitaxel, carboplatin	Drug	Treatment group B

Primary outcome

Objective response rate
Time frame: 18 weeks
optimal ORR at 18 weeks, independent radiographic assessment

8 secondary outcomes

Progression-free survival
Time frame: 41 months
Overall survival (OS)
Time frame: 41 months
Disease Control Rate (DCR)
Time frame: 41 months
Duration of Response (DoR)
Time frame: 41 months
Quality of Life assessment using EORTC QLQ-C30
Time frame: 41 months
Incidence of treatment-emergent adverse events, serious adverse events
Time frame: Enrollment to 28 days after permanent treatment termination
Positive rate of anti-bevacizumab antibody and its titer
Time frame: 41 months
Positive rate of neutralizing antibody
Time frame: 41 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
Individual participant dataSharing planned: Undecided

Related trials for Non-small Cell Lung Cancer(NSCLC)

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05169801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.