Metastatic Non-small Cell Lung Cancer (NSCLC)Phase 3NCT04466917
A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
A Phase 3 study testing ABP 215, Bevacizumab and Paclitaxel in people with Metastatic Non-small Cell Lung Cancer (NSCLC) and Non-squamous NSCLC, run by Amgen.
Trial summary
The purpose of this research study is to assess the efficacy and safety of ABP 215 compared to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer (NSCLC), Non-squamous NSCLC
- What is being tested?
- ABP 215, Bevacizumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2021to 13 Nov 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed non-squamous NSCLC.
- Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 and no more than 6 cycles of chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
- Other inclusion criteria may apply.
Who cannot join
- Small cell lung cancer (SCLC) or mixed SCLC and NSCLC.
- Central nervous system (CNS) metastases.
- Malignancy other than NSCLC.
- Palliative radiotherapy for bone lesions inside the thorax.
- Prior radiotherapy of bone marrow.
- Active hepatitis B.
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- Active hepatitis C.
- Tested positive for human immunodeficiency virus (HIV).
- Life expectancy < 6 months.
- Woman of childbearing potential who is pregnant or is breast feeding.
- Woman of childbearing potential who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment.
- Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment.
- Other exclusion criteria may apply.
About this study
Official title: A Randomized, Double-blind, Phase 3 Bridging Study Evaluating the Safety and Efficacy of ABP 215 Compared With Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
The purpose of this research study is to assess the efficacy and safety of ABP 215 compared to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).
Read the detailed description
Approximately 170 subjects will be randomized 1:1 in approximately 40 sites in China. This study consists of a screening period of up to 28 days, followed by a treatment period of 18 weeks, and an end of study visit 3 weeks after the last dose of investigational product or study-specified chemotherapy. After randomization, subjects will receive investigational product at a dose of 15 mg/kg administered every 3 weeks for 6 cycles followed by at least 4 and no more than 6 cycles of carboplatin and paclitaxel chemotherapy every 3 weeks.
- Being tested
- ABP 215, Bevacizumab, Paclitaxel, Carboplatin
- Keywords
- Biosimilar, Bevacizumab, Carboplatin, Paclitaxel
- 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.
ABP 215Drug
ABP 215 will be administered at a dose of 15 mg/kg IV
BevacizumabDrug
Bevacizumab will be administered at a dose of 15 mg/kg IV
PaclitaxelDrug
Paclitaxel will be administered 175 mg/m2 IV
CarboplatinDrug
Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV
| Study group | Role | What they receive |
|---|---|---|
| ABP 215 | Experimental | Subjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles.
All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles. Receives: Drug: ABP 215; Drug: Paclitaxel; Drug: Carboplatin |
| Bevacizumab | Active comparator | Subjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles.
All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles. Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The percentage of subjects with a best overall tumor response of Complete Response (CR) or Partial Response (PR).
Measured: From Day 1 to Week 19 (EOS)
Secondary outcomes (8)
Progression-free survival (PFS)
Measured: From Day 1 to Week 19 (EOS)
Duration of response (DOR)
Measured: From Day 1 to Week 19 (EOS)
Maximum Plasma Concentration (Cmax)
Measured: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Area Under the Curve (AUC)
Measured: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Minimum observed concentration (Cmin)
Measured: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Number of participants with treatment-emergent adverse events
Measured: From Screening to Week 19 (EOS)
Number of participants with treatment-emergent events of interest (EOIs)
Measured: From Screening to Week 19 (EOS)
Number of participants with incidence of anti-drug antibodies (ADAs)
Measured: On Week 1, Week 7, Week 13 and Week 19 (EOS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start15 May 2021 (estimated)
- Primary completion13 Nov 2022 (estimated)
- Study completion13 Nov 2022 (estimated)
Why it stopped: Sponsor decision to early terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Subjects will be randomized to receive ABP 215 or bevacizumab on a 1:1 basis. All subjects will receive chemotherapy, following administration of investigational product.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466917
- Sponsor's protocol ID
- 20180085
- Status last verified
- May 2021
- First submitted
- 7 Jul 2020
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Phase 3 Bridging Study Evaluating the Safety and Efficacy of ABP 215 Compared With Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04466917
- Acronym / sponsor ID
- 20180085
- Keywords
- Biosimilar, Bevacizumab, Carboplatin, Paclitaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision to early terminate the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 15 May 2021 (estimated)
- Primary completion
- 13 Nov 2022 (estimated)
- Study completion
- 13 Nov 2022 (estimated)
- First posted
- 10 Jul 2020 (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.
The purpose of this research study is to assess the efficacy and safety of ABP 215 compared to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).
Detailed description
Approximately 170 subjects will be randomized 1:1 in approximately 40 sites in China. This study consists of a screening period of up to 28 days, followed by a treatment period of 18 weeks, and an end of study visit 3 weeks after the last dose of investigational product or study-specified chemotherapy. After randomization, subjects will receive investigational product at a dose of 15 mg/kg administered every 3 weeks for 6 cycles followed by at least 4 and no more than 6 cycles of carboplatin and paclitaxel chemotherapy every 3 weeks.
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
- Subjects will be randomized to receive ABP 215 or bevacizumab on a 1:1 basis. All subjects will receive chemotherapy, following administration of investigational product.
| Arm | Type | Receives |
|---|---|---|
| ABP 215 | Experimental | Drug: ABP 215, Drug: Paclitaxel, Drug: CarboplatinSubjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles. |
| Bevacizumab | Active comparator | Drug: Bevacizumab, Drug: Paclitaxel, Drug: CarboplatinSubjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed non-squamous NSCLC.
- Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 and no more than 6 cycles of chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
- Other inclusion criteria may apply.
Key exclusion criteria (13 listed)
- Small cell lung cancer (SCLC) or mixed SCLC and NSCLC.
- Central nervous system (CNS) metastases.
- Malignancy other than NSCLC.
- Palliative radiotherapy for bone lesions inside the thorax.
- Prior radiotherapy of bone marrow.
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 |
|---|---|---|
| ABP 215ABP 215 will be administered at a dose of 15 mg/kg IV | Drug | ABP 215 |
| BevacizumabBevacizumab will be administered at a dose of 15 mg/kg IV | Drug | Bevacizumab |
| PaclitaxelPaclitaxel will be administered 175 mg/m2 IV | Drug | ABP 215, Bevacizumab |
| CarboplatinCarboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV | Drug | ABP 215, Bevacizumab |
Primary outcome
Objective response rate (ORR)
Time frame: From Day 1 to Week 19 (EOS)
The percentage of subjects with a best overall tumor response of Complete Response (CR) or Partial Response (PR).
8 secondary outcomes
Progression-free survival (PFS)
Time frame: From Day 1 to Week 19 (EOS)
Duration of response (DOR)
Time frame: From Day 1 to Week 19 (EOS)
Maximum Plasma Concentration (Cmax)
Time frame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Area Under the Curve (AUC)
Time frame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Minimum observed concentration (Cmin)
Time frame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Number of participants with treatment-emergent adverse events
Time frame: From Screening to Week 19 (EOS)
Number of participants with treatment-emergent events of interest (EOIs)
Time frame: From Screening to Week 19 (EOS)
Number of participants with incidence of anti-drug antibodies (ADAs)
Time frame: On Week 1, Week 7, Week 13 and Week 19 (EOS)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABP 215, Bevacizumab and Paclitaxel in people with Metastatic Non-small Cell Lung Cancer (NSCLC) and Non-squamous NSCLC, run by Amgen.
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 4 inclusion and 13 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: withdrawn, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 (ORR) (time frame: From Day 1 to Week 19 (EOS)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2023.