Chemotherapy + Bevacizumab for Non-Small Cell Lung Cancer

Recruiting at 1266 trial locations

Overseen by Heather A Wakelee

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

Research Team

Heather A Wakelee

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for adults with stage IB-IIIA non-small cell lung cancer removed by surgery. They must not have had hormonal or radiation therapy within the last 5 years, be recovered from surgery, and have good organ function and blood counts. Pregnant or breastfeeding women can't join, nor can those with recent serious health issues like heart failure or bleeding disorders. Participants need controlled blood pressure and no history of stroke or significant infections.

Inclusion Criteria

Your SGPT (ALT) level in the blood is less than 5 times the upper limit of normal.

I had surgery to remove my lung cancer, which was not a minor procedure, and had specific lymph nodes checked.

Your total bilirubin level must be less than or equal to 1.5 mg/dL.

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Cisplatin (Alkylating agents)
• Docetaxel (Anti-tumor antibiotic)
• Gemcitabine Hydrochloride (Anti-metabolites)
• Pemetrexed Disodium (Anti-metabolites)
• Questionnaire Administration (Other)
• Vinorelbine Tartrate (Anti-tumor antibiotic)

Trial Overview The study tests if adding Bevacizumab to chemotherapy after surgery improves outcomes in non-small cell lung cancer patients. It's a phase III trial comparing standard chemo alone versus chemo plus Bevacizumab, which may block tumor growth by inhibiting blood vessel formation.

Participant Groups

Group I: Arm II (chemotherapy, bevacizumab) Experimental Treatment 8 Interventions

Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Group II: Arm I (chemotherapy) Active Control 7 Interventions

Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1

Cisplatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

SWOG Cancer Research Network

Collaborator

Trials

403

Recruited

267,000+

Southwest Oncology Group

Collaborator

Trials

389

Recruited

260,000+

Cancer and Leukemia Group B

Collaborator

Trials

81

Recruited

118,000+

North Central Cancer Treatment Group

Collaborator

Trials

49

Recruited

81,100+

NCIC Clinical Trials Group

Collaborator

Trials

190

Recruited

145,000+