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COMPLETEDPHASE3

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

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

NCT01951482•Sun Yat-sen University

View on ClinicalTrials.gov

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. The safety is evaluated as well.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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);
•2. 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.
•3. Age 18-75 years old;
•4. Physical condition ECOG score (PS) 0-1;
•5. 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.
•6. Expected survival time is greater than 12 weeks;
•7. 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;
•8. Ability to comply with study and follow-up procedures;
•9. The patient understands and voluntarily signs the written informed consent.

Exclusion Criteria

•1. Mixed non-small cell and small cell carcinoma, or mixed adenosquamous carcinoma with squamous cells as the main component;
•2. Before selection3 A history of hemoptysis within the past month, that is, coughing up at least half a teaspoon of blood;
•3. Brain metastases with bleeding;
•4. 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);
•5. 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;
•6. First-time bevacizumab/Before placebo treatment48 Minor surgical procedures (including port placement) within 24 hours PICC except);
•7. 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;
•8. 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;
•9. History or examination findings suggest an inherited bleeding tendency or coagulopathy. Patients with impaired blood flow and thus potentially increased risk of bleeding;
•10. Uncontrolled high blood pressure (systolic blood pressure\>150 mmHg and/or diastolic blood pressure\>100 mmHg);
+12 more criteria

Locations (1)

Sun Yat-sen University of Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

January 1, 2016

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2024

Last Updated

August 17, 2025

Enrollment

160

ACTUAL participants

Conditions

Non Squamous Non-small Cell Lung CancerBrain MetastasesBevacizumab

Interventions

Pemetrexed/Platinum

DRUG

Bevacizumab and Pemetrexed/platinum

DRUG

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

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Brain MetastasesNonsmall Cell Lung Cancer Stage III

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RECRUITING

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Gastric CancerEsophageal Cancer+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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