Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer

Study summary

Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCisplatin and Etoposide

Plus 2 other study approaches.

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

These are broad labels—not an eligibility decision.

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

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Nasser Hanna, M.D.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Nasser Hanna, M.D.
Interventions being studied: Drug: Cisplatin; Drug: Etoposide; Procedure: Radiotherapy; Drug: Sorafenib

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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→Locally advanced→

Treatment approach

Chemotherapy→Radiation therapy→

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

Histological or cytological proof of non-small cell lung cancer (NSCLC).
Measurable or non-measurable disease per RECIST.
Unresectable Stage IIIA or IIIB disease as evaluated by imaging.
Must be age ≥ 18 years at the time of consent.
Written informed consent and HIPAA authorization for release of personal health information.
Females of childbearing potential and males must be willing to use an effective method of contraception.
Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for initial therapy.

Reasons someone may not be able to joinExclusion criteria

No prior chemotherapy or radiotherapy for lung cancer.
No positive supraclavicular or scalene lymph nodes extending up into the cervical region.
No superior sulcus (pancoast tumors).
No malignant pleural effusions. The only exception is a patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR deemed too small to tap.
No clinically significant or malignant pericardial effusions.
No CNS metastases.
No unintended weight loss (\> 5% body weight) in the preceding 90 days prior to registration for initial therapy.
No treatment with any investigational agent within 30 days prior to being registered for initial therapy.
No prior therapy with a Ras pathway inhibitor or anti-angiogenic agent.
No other active cancers.
Females must not be breastfeeding.
No active clinically serious infections as judged by the treating investigator (\> CTC v3, Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
No major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for initial therapy.
No anticipation of need for major surgical procedure during the course of the study.
No minor surgical procedures such as fine needle aspirations or cone biopsies within 7 days prior to registration for initial therapy.
No history of allergic reactions to drugs utilizing the vehicle polysorbate 80 + polyethylene glycol (etoposide).
No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for initial therapy.
No use inhibitors or inducers of the cytochrome p450 system CYP3A4 enzyme or other medications such as aprepitant, ketoconazole, itraconazole, quinidine, digoxin, cyclosporine, ritonavir, grapefruit products, St. John's Wort, rifampin (rifampicin), carbamazepine, phenytoin, dexamethasone, and phenobarbital.
No evidence or history of bleeding diathesis or coagulopathy.
No serious non-healing wound, ulcer, or bone fracture.
No known or suspected allergy to sorafenib.
No uncontrolled hypertension defined as systolic blood pressure \> 150 mm Hg or diastolic pressure \> 90 mm Hg, despite optimal medical management.
No thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within 6 months prior to registration for initial therapy.
No pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks prior to registration for initial therapy.
No hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to registration for initial therapy.
No condition that impairs patient's ability to swallow whole pills or any malabsorption problem.

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

Medical & Surgical Specialists, LLCGalesburg, Illinois
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana
Center for Cancer Care at Goshen Health SystemGoshen, Indiana
Indiana University Cancer CenterIndianapolis, Indiana
Horizon Oncology CenterLafayette, Indiana
Medical Consultants, P.C.Muncie, Indiana
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana
Oncology Partners NetworkCincinnati, Ohio

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

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