New cocktail for tough lung cancer shows promise in small trial
NCT ID NCT00334815
First seen Jun 24, 2026 · Last updated Aug 27, 2026 · Updated 7 times
Summary
This phase 2 pilot trial tested adding the drug bevacizumab to standard chemotherapy and radiation for patients with stage III non-small cell lung cancer that cannot be removed by surgery. The study enrolled 29 newly diagnosed patients to see if the combination is safe and helps control the cancer. Bevacizumab works by blocking blood flow to tumors, while chemo and radiation kill cancer cells directly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bevacizumab (Avastin) plus cisplatin, etoposide, docetaxel, and radiation therapy
- What this could lead to
- If successful, this combination could improve control of advanced lung cancer that cannot be surgically removed, potentially extending survival.
- What could go wrong
- This is a small, early-phase pilot trial with only 29 participants, so results may not apply broadly. Adding bevacizumab to chemotherapy and radiation can increase side effects like bleeding or blood clots.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
29 people
The number who actually took part.
- Started
-
Jun 2006
- Expected to finish
-
Feb 2027
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically confirmed single, primary, bronchogenic, non-small cell lung cancer (NSCLC) * Newly diagnosed disease * Unresectable disease * No more than 1 parenchymal lesions on same or opposite sides of the lungs * Meets 1 of the following stage criteria: * Stage IIIA (N2) disease meeting the following criteria: * N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or x-ray so that the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection * N2 status must be documented by ≥ 1 of the following methods: * Histologically or cytologically confirmed N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle biopsy (WNB), fine needle aspiration (FNA) under bronchoscopic or CT guidance, or any other method * Node positive by fludeoxyglucose-positron emission tomography (FDG-PET) scan * Nodes \> 3 cm on CT scan * Paralyzed left true vocal cord with separate left lung primary distinct from anterior-posterior window nodes on CT scan * Stage IIIB disease meeting ≥ 1 of the following criteria: * Histologically or radiographically confirmed positive N3 nodes\*, documented by ≥ 1 of the following methods: * FNA, core needle biopsy (CNB), or excisional biopsy of supraclavicular N3 nodes * Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy, or thoracotomy * FNA, CNB, or WNB under CT or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes * Contralateral mediastinal nodes \> 3 cm on CT scan * Node positivity by FDG-PET scan * Right-sided primary with paralyzed left true vocal cord * T4 lesions of any size that invade the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina, documented by ≥ 1 of the following methods: * Written documentation of type of T4 extent if patient had a prior exploratory thoracotomy or thoracoscopy * T4 involvement of the trachea or carina by direct bronchoscopic visualization * T4 involvement of the heart, esophagus, aorta, or vertebral body by CT scan, MRI, or transesophageal ultrasound * T4 involvement of the mediastinum by CT scan or MRI if, in the absence of the above organ involvement, there is soft tissue extension directly into the mediastinal space\*\* * Meets 1 of the following risk criteria: * Low risk disease, meeting the following criteria: * Non-squamous cell NSCLC, including adenocarcinoma, bronchoalveolar cell carcinoma, or large cell carcinoma * If mixed histology, the squamous cell carcinoma component must be \< 50% * Histology or cytology from involved mediastinal or supraclavicular lymph nodes allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., second biopsy not required) * No primary tumor with cavitation and/or tumor within 1 cm of a major vessel * No hemoptysis (i.e., bright red blood ≥ ½ teaspoon) in the past 28 days * High-risk\* disease, meeting ≥ 1 of the following criteria: * Squamous cell NSCLC * If mixed histology, the squamous cell component must be ≥ 50% * Tumor with any histology that has cavitation or is located within 1 cm of a major vessel * No aortic involvement * Any histology and hemoptysis (i.e., bright red blood ≥ ½ teaspoon) within past 28 days * Measurable or nonmeasurable disease by CT scan or MRI * Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease * No pleural effusion except for small pleural effusion visible on CT scan or MRI alone * No pericardial effusions * No metastatic disease involving the contralateral chest, liver, or adrenals confirmed by CT scan of the upper abdomen or by chest CT scan with complete liver and adrenals in the report * Patients must be offered participation in SWOG-S9925 (Lung Cancer Specimen Repository Protocol) * No brain metastases by CT scan or MRI * No evidence of cavitation * Creatinine normal * Creatinine clearance ≥ 50 mL/min * FEV\_1 ≥ 2.0 liters OR predicted FEV\_1 of the contralateral lung \> 800 mL * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Urine protein: creatinine ratio ≤ 0.5 by urinalysis OR urine protein \< 1,000 mg by 24-hour urine collection * INR \< 1.5 * Zubrod performance status 0-1 * No sensory neuropathy \> grade 1 * No cerebrovascular accident within the past 6 months * No myocardial infarction or unstable angina within the past 6 months * No uncontrolled hypertension * No New York Heart Association class II-IV congestive heart failure * No serious cardiac arrhythmia requiring medication * No clinically significant peripheral vascular disease * No evidence of bleeding diathesis or coagulopathy * No pathologic condition other than lung cancer that carries a high risk of bleeding * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * No serious, nonhealing wound, ulcer, or bone fracture * No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or other cancer for which the patient has been disease-free for 5 years * Not pregnant or nursing * No nursing during and for ≥ 6 months after the last dose of bevacizumab * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 6 months after the last dose of bevacizumab * Must have pre-treatment simulation demonstrating a V20 ≤ 35% with planned radiation dose of 6,480 cGy * No prior surgical resection * Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery allowed for diagnosing, staging, or determining potential resectability of lung tumor * No prior chemotherapy or radiotherapy for lung cancer * No prior radiotherapy to the neck or thorax * At least 4 weeks since prior thoracic or other major surgery (excluding mediastinoscopy) and recovered * More than 7 days since prior FNA, CNB, or mediastinoscopy * No other concurrent anticancer therapy, including chemotherapy, radiotherapy, or biologic agents * No other concurrent investigational drugs * No concurrent major surgical procedures * No concurrent full-dose anticoagulants (e.g., low-molecular weight and unfractionated heparin or warfarin) * Low-dose warfarin (i.e., 1 mg) is allowed to prevent clotting of an infusaport or central line * No concurrent brachytherapy, radiopharmaceuticals, high linear energy transfer radiation (i.e., fast neutrons), particle therapy (i.e., protons, carbon, or helium), and/or altered fractionation schemes * No concurrent intensity-modulated radiotherapy * No concurrent prophylactic contralateral hilar or supraclavicular lymph node radiotherapy
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Lung adenocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905, United States
-
Audie L Murphy VA Hospital
San Antonio, Texas, 78229, United States
-
Ballad Health Cancer Care - Norton
Norton, Virginia, 24273, United States
-
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
-
Cancer Centers of Central Florida PA
Leesburg, Florida, 34788, United States
-
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton, Massachusetts, 02135, United States
-
Danville Regional Medical Center
Danville, Virginia, 24541, United States
-
Denver Health Medical Center
Denver, Colorado, 80204, United States
-
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, United States
-
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
-
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161, United States
-
HaysMed
Hays, Kansas, 67601, United States
-
Highland Clinic
Shreveport, Louisiana, 71105, United States
-
Highland Hospital
Rochester, New York, 14620, United States
-
Highlands Oncology Group - Rogers
Rogers, Arkansas, 72758, United States
-
Hutchinson Regional Medical Center
Hutchinson, Kansas, 67502, United States
-
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128, United States
-
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
-
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
-
Loyola University Medical Center
Maywood, Illinois, 60153, United States
-
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043, United States
-
Montana Cancer Consortium NCORP
Billings, Montana, 59102, United States
-
Montrose Memorial Hospital
Montrose, Colorado, 81401, United States
-
MultiCare Allenmore Hospital
Tacoma, Washington, 98405, United States
-
MultiCare Auburn Medical Center
Auburn, Washington, 98001, United States
-
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372, United States
-
Northbay Cancer Center
Vacaville, California, 95687, United States
-
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
-
Olathe Cancer Center
Olathe, Kansas, 66061, United States
-
Oregon Health and Science University
Portland, Oregon, 97239, United States
-
Portland VA Medical Center
Portland, Oregon, 97239, United States
-
Providence - Saint Peter Hospital
Olympia, Washington, 98506-5166, United States
-
Providence Hospital
Mobile, Alabama, 36608, United States
-
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531, United States
-
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, 95405, United States
-
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045, United States
-
Roper Hospital
Charleston, South Carolina, 29401, United States
-
Saint Bernards Regional Medical Center
Jonesboro, Arkansas, 72401, United States
-
Saint Clare Hospital
Lakewood, Washington, 98499, United States
-
Saint Francis Hospital
Federal Way, Washington, 98003, United States
-
Saint Joseph Medical Center
Tacoma, Washington, 98405, United States
-
Salina Regional Health Center
Salina, Kansas, 67401, United States
-
Shaw Cancer Center
Edwards, Colorado, 81632, United States
-
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem, North Carolina, 27104, United States
-
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
-
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
-
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
-
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
-
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
-
University Hospital
San Antonio, Texas, 78229, United States
-
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
-
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
-
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
-
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606, United States
-
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
-
University of Rochester
Rochester, New York, 14642, United States
-
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
-
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
-
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, 81601, United States
-
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
-
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a routine blood clot test predict Cancer's next move?
- Can AI be a Pathologist's second opinion?
- Could a genetic marker guide future cancer therapies in taiwan?
- Blood tests could unlock early clues for three major lung diseases
- New biologic drug DBC-664 takes aim at Hard-to-Treat cancers
- Why some Never-Smokers get lung cancer: a new study investigates