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Monoclonal Antibodies

Chemotherapy + Radiation + Bevacizumab for Lung Cancer

Phase 2

Waitlist Available

Led By Antoinette J Wozniak

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unresectable disease

Histologically or cytologically confirmed single, primary, bronchogenic, non-small cell lung cancer (NSCLC)

Must not have

No serious cardiac arrhythmia requiring medication

No clinically significant peripheral vascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of chemotherapy drugs, radiation therapy, and the drug bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer.

Who is the study for?

This trial is for adults with newly diagnosed stage III non-small cell lung cancer that can't be removed by surgery. They should not have had previous treatments for lung cancer, no serious wounds or fractures, and must not be pregnant or nursing. Participants need to meet specific medical criteria like normal kidney function and blood counts, and they cannot have brain metastases or other conditions that pose a high risk of bleeding.

What is being tested?

The study tests a combination of chemotherapy drugs (cisplatin, etoposide, docetaxel), radiation therapy, and the monoclonal antibody bevacizumab. The goal is to see if this mix can better kill tumor cells by stopping their growth and cutting off their blood supply compared to standard treatments.

What are the potential side effects?

Possible side effects include increased risk of bleeding due to bevacizumab's effect on blood vessels; nerve damage; fatigue from chemotherapy; skin reactions from radiation; as well as potential heart problems like hypertension or congestive heart failure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition cannot be treated with surgery.

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My lung cancer is confirmed to be non-small cell type.

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My lung cancer is non-squamous and considered low risk.

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My lung cancer is considered high-risk based on its type and test results.

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My cancer is at stage IIIB with specific conditions.

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I am not currently undergoing intensity-modulated radiotherapy.

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I have 1 or fewer lung lesions.

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I do not have any serious wounds, ulcers, or broken bones that are not healing.

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My condition was recently diagnosed.

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I have not had surgery to remove my condition.

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I am not currently receiving any specialized radiation treatments.

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I am not receiving preventive radiation therapy to lymph nodes near my collarbone or opposite lung.

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My lung can handle the planned radiation dose without too much damage.

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I am not receiving any other cancer treatments right now.

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I have not had chemotherapy or radiotherapy for lung cancer.

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It's been over 4 weeks since my last major surgery and I have recovered.

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My kidney, lung function, blood counts, and clotting ability are normal.

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My cancer is at stage IIIA with specific N2 lymph node involvement.

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I am not on any full-dose blood thinners.

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I am not undergoing any major surgeries right now.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a serious heart rhythm problem that needs medication.

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I do not have serious blood vessel problems in my arms or legs.

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I haven't had a heart attack or unstable chest pain in the last 6 months.

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I have not had a stroke in the last 6 months.

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My cancer has not spread to the opposite chest, liver, or adrenals.

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I do not have severe numbness or pain in my hands or feet.

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My blood pressure is under control.

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I have not had radiation therapy to my neck or chest.

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I don't have any conditions besides lung cancer that increase my risk of bleeding.

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My heart functions well without severe symptoms.

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I do not have any bleeding or clotting disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Secondary study objectives

Overall Survival

Progression-free Survival

Response Rate (Confirmed or Unconfirmed Partial Response)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3 (cisplatin, etoposide, radiotherapy, bevacizumab)Experimental Treatment7 Interventions

Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 22, and 43.

Group II: Group 2 (cisplatin, etoposide, radiotherapy, bevacizumab)Experimental Treatment7 Interventions

Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 15, 36, and 57.

Group III: Group 1 (cisplatin, etoposide, radiotherapy)Experimental Treatment6 Interventions

Patients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Etoposide

2010

Completed Phase 3

~2960