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Non-Small Cell Lung CancerPhase 3NCT01364012

A Study of Bevacizumab Versus Placebo in Combination With Carboplatin/Paclitaxel in Participants With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Previous Chemotherapy

A Phase 3 study testing Bevacizumab, Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 17 sites in China.

Completed

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

Official record
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Trial summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of bevacizumab (Avastin) versus placebo in combination with carboplatin/paclitaxel in participants with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy for advanced… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Bevacizumab, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
17 sitesChina
Study dates
23 May 2011to 17 Aug 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced (Stage IIIb not amenable for combined modality treatment), metastatic (Stage IV) or recurrent non-squamous non-small cell lung cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Adequate hematological, renal and liver function

Who cannot join

  • Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of the disease (Stage IIIb, IV or recurrent disease)
  • Mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
  • Evidence of tumor invading major blood vessels on imaging
  • Central nervous system (CNS) metastases, even if previously treated
  • History of hemoptysis in the 3 months prior to enrollment
  • History or evidence of inherited bleeding diathesis or coagulopathy
Show all 9Show fewer
  • Uncontrolled hypertension and/or history of hypertensive crisis or hypertensive encephalopathy
  • Clinically significant cardiovascular or vascular disease
  • Malignancies other than non-small cell lung cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or localized prostate cancer or ductal carcinoma in situ treated surgically with curative intent

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

    Beijing, 100071

  • Beijing Cancer Hospital

    Beijing, 100142

  • Beijing Hospital of Ministry of Health; Hematology

    Beijing, 100730

  • General Hospital of Chinese PLA; Department of Hematology

    Beijing, 100853

  • Beijing Chest Hospital; Oncology Department

    Beijing, 101149

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Guangdong General Hospital

    Guangzhou, 510080

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310016

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

  • Shanghai chest hospital

    Shanghai, 200030

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515041

Other trials in China

About this study

Official title: A Randomized, Double-blinded, Placebo-controlled, Multicenter Phase III Study Comparing Bevacizumab Plus Carboplatin/Paclitaxel Versus Placebo Plus Carboplatin/Paclitaxel in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy For Advanced Disease

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of bevacizumab (Avastin) versus placebo in combination with carboplatin/paclitaxel in participants with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy for advanced disease. Participants will be randomized to receive either bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) or placebo on Day 1 of each 3 week cycle, plus up to 6 cycles of carboplatin/paclitaxel. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. After progression, participants in the bevacizumab arm may continue to receive bevacizumab in combination with approved second- and third-line treatment at the discretion of the investigator, up to the third progression.

Being tested
Bevacizumab, Carboplatin, Paclitaxel, Placebo
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.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab will be administered at 15 mg/kg IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.

  • CarboplatinDrug

    Carboplatin will be administered at area under the plasma concentration-time curve (AUC) 6.0 IV on Day 1 of each 3-week cycle, up to 6 cycles.

  • PaclitaxelDrug

    Paclitaxel will be administered at 175 milligrams per square meter (mg/m^2) IV on Day 1 of each 3-week cycle, up to 6 cycles.

  • PlaceboDrug

    Bevacizumab matching placebo will be administered IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.

Study groups in NCT01364012
Study groupRoleWhat they receive
Bevacizumab + Paclitaxel/CarboplatinExperimentalParticipants will receive bevacizumab on Day 1 of each 3-week cycle in combination with paclitaxel and carboplatin for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive bevacizumab on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel
Placebo + Paclitaxel/CarboplatinActive comparatorParticipants will receive bevacizumab matching placebo on Day 1 of each 3-week cycle in combination with paclitaxel and carboplatin for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive bevacizumab matching placebo on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Placebo

What is being measured

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

  1. Progression-Free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0) Criteria

    Measured: Baseline up to death or disease progression, whichever occurs first (up to approximately 20 months)

Secondary outcomes (11)

  1. Overall Survival (OS)

    Measured: Baseline up to death (up to approximately 35 months)

  2. Percentage of Participants Who are Alive at Year 1

    Measured: Year 1

  3. Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed Using RECIST v1.0 Criteria

    Measured: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)

  4. Duration of Response as Assessed Using RECIST v1.0 Criteria

    Measured: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)

  5. Percentage of Participants With Adverse Events

    Measured: From baseline up to approximately 35 months

  6. PFS as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by Vascular Endothelial Growth Factor-A (VEGF-A) High/Low Level Expression at Baseline

    Measured: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)

  7. PFS as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) High/Low Level Expression at Baseline

    Measured: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)

  8. OS in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline

    Measured: Baseline up to death (up to approximately 35 months)

  9. OS in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline

    Measured: Baseline up to death (up to approximately 35 months)

  10. Percentage of Participants With Objective Response of CR or PR as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline

    Measured: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)

  11. Percentage of Participants With Objective Response of CR or PR as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline

    Measured: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)

Timeline

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

  1. First posted2 Jun 2011 (estimated)
  2. Study start23 May 2011
  3. Primary completion27 Jan 2013
  4. Study completion17 Aug 2017

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01364012
Sponsor's protocol ID
YO25404
Status last verified
Feb 2018
First submitted
27 May 2011
Last updated
5 Feb 2018
Results posted
No

Publications

  • Zhou C, Wu YL, Chen G, Liu X, Zhu Y, Lu S, Feng J, He J, Han B, Wang J, Jiang G, Hu C, Zhang H, Cheng G, Song X, Lu Y, Pan H, Zheng W, Yin AY. BEYOND: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of First-Line Carboplatin/Paclitaxel Plus Bevacizumab or Placebo in Chinese Patients With Advanced or Recurrent Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Jul 1;33(19):2197-204. doi: 10.1200/JCO.2014.59.4424. Epub 2015 May 26.

    PubMed 26014294

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 17 sites in China.

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 3 inclusion and 9 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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?

Progression-Free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0) Criteria (time frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 20 months)). 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 NCT01364012, which also lists 1 linked publication.

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 5 Feb 2018.

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