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Platinum-containing Compound
Therapeutic Conventional Surgery for Lung Cancer
Phase 2
Waitlist Available
Led By Raymond U Osarogiagbon
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of step 1 randomization to date of death due to any cause, assessed up to 6 years
Awards & highlights
Study Summary
This trial is studying the effect of atezolizumab given with usual chemotherapy and radiation therapy in treating patients with superior sulcus non-small cell lung cancer.
Eligible Conditions
- Superior Sulcus Lung Cancer
- Lung Cancer
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of step 1 randomization to date of death due to any cause, assessed up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of step 1 randomization to date of death due to any cause, assessed up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic complete response (pCR) by local review
Secondary outcome measures
Complete resection (R0) rate
Event-free survival (EFS)
Incidence of adverse events
+3 moreOther outcome measures
Bank blood and tissue for future research
Changes in computed tomography tumor volume
Changes in diffusion weighted imaging (DWI)-magnetic resonance imagining (MRI) metrics
+3 moreSide effects data
From 2013 Phase 3 trial • 4312 Patients • NCT0001198697%
Neutropenia
94%
Leukopenia
80%
Anemia
76%
Thrombocytopenia
47%
Gastrointestinal
43%
Constitutional
38%
Other Hemotologic
34%
Pain
17%
Infection/Fever
17%
Peripheral neurologic
17%
Pulmonary
14%
Neurologic
11%
Metabolic
10%
2nd Primary
9%
Hepatic
8%
Dermatologic
7%
Cardiovascular
6%
Allergy
6%
Hemorrhage
5%
Genitourinary/Renal
5%
Musculoskeletal
4%
Ocular/Visual
3%
Endocrine
2%
Auditory
2%
Thrombosis/Embolism
1%
Ileus
1%
Infection Documented W Grd 3/4 Neutropn.
1%
Infection Without Neutropenia
1%
Coagulation
1%
Sexual
1%
Platelets
1%
Allergic Reaction/Hypersensitivity
1%
Febrile Neutropenia-Fuo Infect Not Docum
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carbo/Gemcitabine - Carbo/Taxol
Carbo/Taxol/Gemcitabine
Carbo/Taxol/Doxil
Carbo/Topotecan - Carbo/Taxol
Carbo/Taxol
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (atezolizumab, chemotherapy, RT, surgery)Experimental Treatment13 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1. Patients also receive one of the chemotherapy combinations below depending on their previous therapy and disease. Between the first day of chemotherapy and the first day of cycle 2 of chemotherapy, patients undergo external beam radiation therapy 5 days per week. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 21 and 90 days after treatment, patients undergo surgery. Within 42 days after completion of surgery, patients then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo a PET scan, CT scan, and MRI on study. Patients also undergo tumor biopsies and blood sample collection throughout the trial.
Group II: Arm II (chemotherapy, RT, surgery)Active Control12 Interventions
Patients receive one of the chemotherapy combinations below depending on their previous therapy and disease. Between the first day of chemotherapy and the first day of cycle 2 of chemotherapy, patients also undergo external beam radiation therapy 5 days per week. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 21 and 90 days after treatment, patients undergo surgery. Patients may undergo a PET scan, CT scan, and MRI on study. Patients also undergo tumor biopsies and blood sample collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Etoposide
2010
Completed Phase 3
~2440
Pemetrexed
2014
Completed Phase 3
~5250
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Paclitaxel
2011
Completed Phase 4
~5380
Positron Emission Tomography
2008
Completed Phase 2
~2240
Atezolizumab
2017
Completed Phase 3
~5860
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Carboplatin
2014
Completed Phase 3
~6670
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,667 Total Patients Enrolled
Raymond U OsarogiagbonPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- A doctor must have checked your health within the last 28 days before you begin the study.You have a condition where fluid builds up around your lungs, heart, or abdomen that requires frequent drainage procedures.It's important to have a specific type of MRI called DWI (Diffusion weighting imaging) for this study.You can participate in non-treatment studies like quality of life assessments or comfort care evaluations at the same time as this trial.You must have a Zubrod performance status of 0-1 within the past 28 days before being chosen randomly for Step 1.You need approval from a team of doctors who specialize in lung cancer treatment to confirm that you are eligible for surgery and chemotherapy/radiation treatment. The doctor treating you must confirm that you have been evaluated and approved by each specialist.You must have had an MRI or CT scan of your brain (preferably with contrast) within 42 days before starting the trial.You must be 18 years old or older to participate.You have received a transplant of either stem cells or a solid organ in the past.You have received treatment for your cancer before such as surgery, chemotherapy, radiation therapy, targeted therapy, or immunotherapy.You have already received medications that activate the immune system to fight cancer, such as anti-CTLA-4, anti-PD-1, and anti-PD-L1 antibodies.You will be asked if you would like to store your samples for future research.You previously received radiation therapy in the same area where you will receive treatment as part of this study.You have a type of lung cancer called non-small cell lung cancer (NSCLC) that has grown into the tissues around the top part of your lung.You can participate in the study even if you don't have measurable disease, as long as your non-measurable disease has been assessed within 42 days of the first randomization. All sites of disease must be documented. If you have measurable disease, it should be checked within 28 days before the first randomization.Before joining the study, you must have had a chest CT scan (preferably with a special dye), a contrast MRI scan (of your upper chest), and a PET/CT scan (using a special radioactive substance) within the last 28 days.You are allowed to participate in studies that do not involve treatment, such as studies related to improving quality of life.You have had or currently have another type of cancer that may affect the safety or effectiveness of the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (chemotherapy, RT, surgery)
- Group 2: Arm I (atezolizumab, chemotherapy, RT, surgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are included in this clinical trial?
"This clinical trial needs 60 participants that meet the eligibility requirements. The locations where patients can receive treatment and participate in the trial include University of Oklahoma Health Sciences Center in Oklahoma City, Oklahoma and McFarland Clinic PC - Ames in Ames, Iowa."
Answered by AI
Has the FDA given the green light to Therapeutic Conventional Surgery?
"While Phase 2 trials do not have data supporting efficacy, there is some evidence that suggests Therapeutic Conventional Surgery is safe. Consequently, it received a score of 2."
Answered by AI
Are there any other precedent medical studies which have employed Therapeutic Conventional Surgery?
"City of Hope Comprehensive Cancer Center first began to study Therapeutic Conventional Surgery in 1997 and, since then, 2801 clinical trials have completed. As of now, 2070 studies are still active with a concentration of these investigations taking place in Oklahoma City, Oklahoma."
Answered by AI
Are there any hospitals outside of North America testing this medication?
"There are a total of 41 sites currently running this trial, with locations in Oklahoma City, Ames, Urbana and 38 other places. If you decide to participate it would be best to try and select a clinic close to your residence to reduce travel time demands."
Answered by AI
Is this study currently enrolling new participants?
"That is accurate. According to the information available on clinicaltrials.gov, this study was first posted on September 9th, 2021 and is currently recruiting patients for 60 spots at 41 different sites."
Answered by AI
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