A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Biological: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762034

9707

H3E-MC-JMHD (Other Identifier)

Details and patient eligibility

About

This study will compare overall survival in participants with Stage IIIB or IV nonsquamous non-small cell lung cancer.

Enrollment: 939 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• You must sign an informed consent document for clinical research.
• You must have Stage IIIB or Stage IV nonsquamous non-small cell lung cancer.
• You must not have received any prior treatment for your disease.
• Prior radiation therapy is allowed to < 25% of the bone marrow; however, prior radiation to the whole pelvis is not allowed. If you have had radiation therapy to the chest, you are not eligible to participate.
• You must be at least 18 years of age or older.
• You must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) or disease can be evaluated on computed tomography (CT) scan.
• Your test results assessing the function of blood forming tissue, kidneys and liver must be satisfactory.
• Women must be sterile, postmenopausal or on contraception and men must be sterile (for example post-vasectomy) or on contraception.

Exclusion criteria

• You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).
• You cannot have Non-small Cell Lung Carcinoma (NSCLC) of predominantly squamous cell histology.
• You cannot have known central nervous system (CNS) disease, other than stable, treated brain metastasis.
• You cannot have undergone a surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days of starting the study treatment, or have an anticipated need for major surgery during the study.
• You cannot have a history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis.
• You are currently receiving ongoing treatment with full-dose warfarin or equivalent.
• You cannot have significant vascular disease, serious cardiac conditions (such as heart attack), stroke or transient ischemic attack within 6 months of the trial.
• You cannot have evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
• You cannot have inadequately controlled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.
• You cannot have a serious, nonhealing wound, active ulcer, or untreated bone fracture.
• You cannot have another form of cancer, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years.
• You cannot have received an investigational treatment within 30 days prior to the trial.
• You cannot have previously received treatment with paclitaxel, carboplatin, pemetrexed, or bevacizumab.
• You cannot be pregnant or breast-feeding.
• You cannot have a known sensitivity to any component of paclitaxel, carboplatin, pemetrexed, or bevacizumab.
• You cannot have a history of hemoptysis (coughing blood) within 3 months prior to the trial.
• You are unable to stop taking aspirin more than 1.3 grams per day or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• You are unable or unwilling to take folic acid or vitamin B12 supplementation.
• You are unable to take corticosteroids.
• You have any other on-going illnesses including active infections that may not allow you to adhere to the requirements of the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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939 participants in 2 patient groups

Pem/Carbo/Bev

Experimental group

Description:

Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab

Treatment:

Biological: Bevacizumab

Biological: Bevacizumab

Drug: Pemetrexed

Drug: Carboplatin

Drug: Pemetrexed

Pac/Carbo/Bev

Active Comparator group

Description:

Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab

Treatment:

Drug: Paclitaxel

Biological: Bevacizumab

Biological: Bevacizumab

Drug: Carboplatin