Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) - BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC

Study summary

This is a phase II, single institution trial for patients with clinical Stage IB-IIIA NSCLC (T1-3N0-2M0) who have resectable lung tumors. The primary goal of this study is to show that the addition of bevacizumab to a cisplatin-based chemotherapy in the neoadjuvant setting for non-squamous cell carcinomas improves the rate of pathologic downstaging, which correlates with survival. Downstaging is defined as any decrease in the final pathologic stage compared with the clinical stage before induction therapy.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPre-surgical Treatment with Bevacizumab plus Chemotherapy and Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 25, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Interventions being studied: Drug: Pre-surgical Treatment with Bevacizumab plus Chemotherapy; Drug: Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→

Treatment approach

Chemotherapy→Surgery→

Study topics

Before surgery (neoadjuvant)→After surgery (adjuvant)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Pathologic confirmation of NSCLC at Memorial Sloan-Kettering Cancer Center (MSKCC)
Stages IB, IIA, IIB or IIIA (T1-3N0-2M 0) NSCLC
Patients must be candidates for resection with curative intent.
Measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions
Age \>= 18 years
Karnofsky performance status \>= 70%
Normal marrow function: leukocytes \>= 3,000/µl; absolute neutrophil count ≥ 1,500µl; platelets \>= 100,000 µl; hemoglobin \>= 9gm/dl.
Adequate renal function, with creatinine \<= 1.3 mg/dl or calculated creatinine clearance \>= 60ml/min by Cockcroft-Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)
Adequate hepatic function: total bilirubin within normal limits; AST \<= 1.5 X upper limit of normal (UNL); ALT \<= 1.5 X UNL; alkaline phosphatase \<= 1.5 X UNL.
Women of childbearing age must have a negative urine or blood pregnancy test.
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Patients must have ability to understand and the willingness to sign a written informed consent document.
Eligibility criteria for group B: Patients with SQUAMOUS CELL carcinoma or patients with a NON-SQUAMOUS CELL tumor with a large central tumor in proximity to significant blood vessels or any history of hemoptysis will be assigned to group B (preoperative chemotherapy alone without bevacizumab).

Reasons someone may not be able to joinExclusion criteria

Prior chemotherapy or radiation therapy for NSCLC
Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
Patients with a history of severe hypersensitivity reaction to docetaxel (Taxotere) or other drugs formulated with polysorbate 80
Patients with known hypersensitivity to other recombinant human antibodies
Patients must not be receiving any other investigational agents.
History of stroke or transient ischemic attack (TIA).
History of myocardial infarction or unstable angina within the past 12 months.
Patients who report a hearing deficit at baseline, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (Common Terminology Criteria for Adverse Events \[CTCAE\] grade 2 or higher)
Peripheral neuropathy \> grade 1.
Uncontrolled hypertension
Esophageal varices, non-healing ulcer, wound, or bone fracture
Known HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs.
Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
Women who are pregnant or breast-feeding
Psychiatric illness or social situation that would limit compliance with study requirements

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Memorial Sloan Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 25, 2016. Always confirm current availability with the study team.

View original record ↗