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Non Squamous Non-small Cell Lung CancerPhase 3NCT01951482

Pemetrexed/Platinum With or Without Bevacizumab in Brain Metastases From Patients With EGFR/ALK Negative Non-Squamous Non-small Cell Lung Cancer

A Phase 3 study testing Pemetrexed/Platinum and Bevacizumab and Pemetrexed/platinum in people with Non Squamous Non-small Cell Lung Cancer and Brain Metastases, run by Sun Yat-sen University 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
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Trial summary

This is a multi-center phase 3 randomized controlled study to assess the efficacy of Pemetrexed/platinum with or without Bevacizumab on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR/ALK wild type by intracranial PFS(iPFS), also PFS ,ORR, DCR and OS. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Pemetrexed/Platinum and Bevacizumab and Pemetrexed/platinum
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
Jan 2016to Dec 2024
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 non-small cell lung cancer (Patients with NSCLC who are newly diagnosed or treated with brain metastases who are asymptomatic or whose intracranial hypertension symptoms are relieved after dehydration treatment, and whose baseline examinations show EGFR wild type (tissue specimen or blood specimen) and ALK negative (tissue specimen);
  • Patients with MRI-confirmed brain metastasis and ≥3 brain lesions; or patients with 1-2 brain lesions but not suitable for local treatment or refusing local treatment. At least one of the brain lesions must be >5 mm in diameter.
  • Age 18-75 years old;
  • Physical condition ECOG score (PS) 0-1;
  • The patient's major organ functions are normal, that is, they meet the following criteria: white blood cells count ≥ 4.0x109/L, neutrophil cells count ≥1.5x109/L, hemoglobin ≥100g/L, serum bilirubin ≤1.5 times the upper limit of normal, transaminase ≤2.5 times the upper limit of normal, if there is liver metastasis, less than 5 times the upper limit of normal; serum creatinine is less than 1.5 times the upper limit of normal, or creatinine clearance is greater than 50ml/min and urine protein is <2+. Patients with baseline urine protein ≥2+ should collect 24-hour urine and prove that the 24-hour urine protein quantitative test is ≤1g.
  • Expected survival time is greater than 12 weeks;
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  • Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result must be negative, and they must be willing to use appropriate contraceptive methods during the trial and within 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate contraceptive methods during the trial and within 8 weeks after the last administration of the trial drug or have undergone surgical sterilization;
  • Ability to comply with study and follow-up procedures;
  • The patient understands and voluntarily signs the written informed consent.

Who cannot join

  • Patients who meet any of the following exclusion criteria are not eligible for this trial:
  • Mixed non-small cell and small cell carcinoma, or mixed adenosquamous carcinoma with squamous cells as the main component;
  • Before selection3 A history of hemoptysis within the past month, that is, coughing up at least half a teaspoon of blood;
  • Brain metastases with bleeding;
  • Imaging shows evidence of tumor invasion of large blood vessels. The investigator or radiologist must rule out that the tumor has completely patients with full access, encasement, or invasion into the lumen of large vessels (e.g., pulmonary artery or superior vena cava);
  • Before selection 28 Underwent major surgery (including thoracotomy) within 1 day, suffered major trauma, or patients who are expected to require major surgery during study treatment;
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  • First-time bevacizumab/Before placebo treatment48 Minor surgical procedures (including port placement) within 24 hours PICC except);
  • Currently or recently (before receiving first dose of bevacizumab10 Aspirin use (>325 mg/Days) or other nonsteroidal anti-inflammatory drugs known to inhibit platelet function;
  • Currently or recently (before receiving first dose of bevacizumab10 within 2 days) take full dose orally or parenterally anticoagulants or thrombolytics are used for treatment. Prophylactic use of anticoagulants is allowed in patients with deep venous catheters;
  • History or examination findings suggest an inherited bleeding tendency or coagulopathy. Patients with impaired blood flow and thus potentially increased risk of bleeding;
  • Uncontrolled high blood pressure (systolic blood pressure>150 mmHg and/or diastolic blood pressure>100 mmHg);
  • Patients with previous hypertensive crisis or hypertensive encephalopathy;
  • Clinically significant (e.g., active) cardiovascular disease, including but not limited to CVA or TIA (enter before election ≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Disease Association Classification ≥II congestive heart failure, requiring medication during the study and may severe arrhythmias that interfere with study treatment or cannot be controlled by medication;
  • Before randomization6 Significant vascular disease within 1 month (including but not limited to active vascular disease requiring surgical repair)aneurysm or recent arterial thrombosis) or thrombotic disease;
  • Non-healing wounds, active peptic ulcers, or fractures;
  • In the selected6 History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 1 month;
  • During the study and after the last dose of bevacizumab within 6 months, with an intact uterus (past twenty four 1 month after menopause), but not using effective contraceptive methods (if combined contraception is not contraindicated Women who used oral contraceptives, intrauterine devices, barrier methods combined with spermicidal gels, or sterilization in the setting of background chemotherapy. Men who do not agree to use effective contraceptive methods;
  • Pregnant and breastfeeding women;
  • Have received any other investigational drug treatment or participated in another clinical trial within 28 days before enrollment;
  • Known hypersensitivity to bevacizumab or any of its excipients and any chemotherapy drug components;
  • Signs of ongoing or active infection requiring intravenous antibiotics, other medical, neurological or metabolic dysfunction, physical examination findings or laboratory test results showing signs of appropriate suspected disease or symptoms that contraindicate the use of the study drug or put the patient at high risk for treatment-related complications;
  • Diagnosed with tracheal-Esophageal fistula;
  • Before randomization5 Years of suffering NSCLC Other malignancies, except for fully treated cervical cancer carcinoma of the uterus, basal cell or squamous cell skin cancer, localized prostate cancer after radical mastectomy, radical mastectomy after ductal carcinoma in situ.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University of Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Bevacizumab+Pemetrexed/Platinum Versus Pemetrexed/Platinum as First-line Therapy in EGFR/ALK Negative Non-squamous Non-small Cell Lung Cancer Patients With Brain Metastases: a Multicenter, Randomized, Controlled, Phase 3 Study

This is a multi-center phase 3 randomized controlled study to assess the efficacy of Pemetrexed/platinum with or without Bevacizumab on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR/ALK wild type by intracranial PFS(iPFS), also PFS ,ORR, DCR and OS. The safety is evaluated as well.

Being tested
Pemetrexed/Platinum, Bevacizumab and Pemetrexed/platinum
Medical subject headings
Brain Neoplasms

What participants receive

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

  • Pemetrexed/PlatinumDrug

    pemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle for four to six cycles, followed by pemetrexed maintenance every 3 weeks.

  • Bevacizumab and Pemetrexed/platinumDrug

    bevacizumab (7.5mg/kg, intravenously on day 1 of each 3-week cycle) plus pemetrexed-platinum chemotherapy (pemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle) for four to six cycles, followed by bevacizumab plus pemetrexed maintenance every 3 weeks.

Study groups in NCT01951482
Study groupRoleWhat they receive
Bevacizumab plus Pemetrexed/platinumExperimentalbevacizumab (7.5mg/kg, intravenously on day 1 of each 3-week cycle) plus pemetrexed-platinum chemotherapy (pemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle) for four to six cycles, followed by bevacizumab plus pemetrexed maintenance every 3 weeks.
Receives: Drug: Bevacizumab and Pemetrexed/platinum
Pemetrexed/platinumActive comparatorpemetrexed 500mg/m2 combined with cisplatin 75mg/m2 or nedaplatin 80mg/m2 intravenously on day 1 of each 3-week cycle for four to six cycles, followed by pemetrexed maintenance every 3 weeks.
Receives: Drug: Pemetrexed/Platinum

What is being measured

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

  1. Compare iPFS(intracranial progression free survival) in two arms

    Measured: 3 Years

Secondary outcomes (2)

  1. Response rate(CR&PR)

    Measured: 3 years

  2. safety

    adverse events (AEs) were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).

    Measured: 1-year

Timeline

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

  1. First posted26 Sep 2013 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2023
  4. Study completionDec 2024

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
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01951482
Sponsor's protocol ID
NSCLC brain metastasis 02
Status last verified
Aug 2025
First submitted
16 Sep 2013
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pemetrexed/Platinum and Bevacizumab and Pemetrexed/platinum in people with Non Squamous Non-small Cell Lung Cancer and Brain Metastases, run by Sun Yat-sen University at 1 site 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 9 inclusion and 23 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 17 Aug 2025. 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?

Compare iPFS(intracranial progression free survival) in two arms (time frame: 3 Years). 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 NCT01951482.

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 17 Aug 2025.

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