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Alkylating agents

Chemotherapy + Bevacizumab for Non-Small Cell Lung Cancer

Phase 3

Waitlist Available

Led By Heather A Wakelee

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

Patients must have undergone complete resection of their non-small cell lung cancer (NSCLC) [stage IB (>= 4 cm)] - [IIIA (T2-3N0, T1-3N1, T1-3N2] prior to enrollment; accepted types of resection will consist of lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy; resections by segmentectomy or wedge resection will not be accepted; mediastinal lymph node sampling at specified levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors)

Patients must not have received hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization; (prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from registration to death, up to 10 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is comparing chemotherapy with or without bevacizumab in treating patients with early stage non-small cell lung cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Chemotherapy side effects include nausea, fatigue, hair loss, increased infection risk, and possible damage to organs. Bevacizumab might cause high blood pressure, bleeding problems, slow wound healing and could increase the risk of developing clots.

Eligibility Criteria

Inclusion Criteria

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

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

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I haven't had hormone or radiation cancer treatments in the last 5 years.

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My blood clotting time is within the normal range, or if I'm on blood thinners, it's not more than 1.5 times the upper limit.

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I have had heart issues but have been symptom-free for over a year.

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I haven't had any cancer in the last 5 years, except for cervical in-situ carcinoma or non-melanoma skin cancer that was fully removed.

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I am not pregnant or breastfeeding.

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My lung cancer is not of the squamous cell type.

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My kidney function is good, as shown by recent tests.

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I am not expecting to undergo any major surgeries during the study.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have never had a stroke or a mini-stroke.

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My urine protein levels are low enough for me to join.

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I haven't had major surgery, serious injuries, or biopsies recently.

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I don't have any serious infections, heart issues, or other conditions that would stop me from following the study's requirements.

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I have never had bleeding disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration to death, up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration to death, up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration to death, up to 10 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

Overall Survival

Secondary study objectives

Disease-free Survival

Other study objectives

Toxicity Rates as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

vitreous syneresis

posterior capsule opacification

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (chemotherapy, bevacizumab)Experimental Treatment8 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 Control7 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Pemetrexed Disodium

2015

Completed Phase 2

~450