- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03141359
Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC
April 11, 2024 updated by: Wake Forest University Health Sciences
LCI-LUN-NSC-SBRT-001: Phase II Prospective Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation and Adjuvant Immunotherapy for Locally-Advanced Non-Small Cell Lung Cancer
This is a single-arm, single-stage Phase II study designed to evaluate the 1-year PFS rate in subjects with locally-advanced NSCLC (stage II/III) and treated with Stereotactic Body Radiation Therapy (SBRT) followed by concurrent mediastinal chemoradiation with or without consolidation chemotherapy.
A total of 60 subjects will be enrolled to this study over a 4 year accrual period.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
This study's primary objective is to assess the efficacy of a treatment regimen involving Stereotactic Body Radiation Therapy (SBRT) delivered to the primary tumor followed by concurrent mediastinal chemoradiation by evaluating the proportion of subjects with locally-advanced non-small cell lung cancer (NSCLC) stage II/III who are alive and progression free at 12 months, and to compare to relevant historical controls.
Additionally, the treatment regimen will be evaluated based on progression free survival, overall survival, radiologic clinical complete response rate following completion of therapy, objective response rate as defined by RECIST v 1.1, local and locoregional control, patterns of failure, and quality of life.
Safety objectives include the rate of grade 2+ radiation pneumonitis and grade 3+ pulmonary events.
Exploratory objectives include differential expression of cytokines and chemokines associated with radiation therapy will be determined.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Levine Cancer Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
Subjects must meet all the following criteria:
- Histologic or cytologic documentation of NSCLC (all histologies allowed)
- Stage II or III disease (AJCC 7th Edition) based on imaging as required during screening: Stage II disease includes only subjects with medically inoperable N1 disease otherwise meeting eligibility criteria. Primary tumor ≤ 7 cm
- Subjects with non-malignant pleural effusion identified on CT scan are eligible provided the effusion is not known or demonstrated to be an exudative effusion. If a pleural effusion is present, the following criteria must be met to exclude malignant involvement: A pleuracentesis is required if pleural fluid is present and visible on both CT scan and chest x-ray. Pleural fluid cytology must be negative for malignancy. Effusions that are minimal and too small for pleuracentesis as determined by the investigator will be eligible for enrollment.
- FEV1 ≥ 1.0 Liter or ≥ 40% predicted with or without bronchodilator within six months prior to initiation of study treatment. Subjects who meet the criterion without O2, but who need acute (started within 10 days prior to enrollment) supplemental oxygen due to tumor-caused obstruction/hypoxia are eligible, provided the amount of the O2 needed has been stable.
- Age ≥18 years.
- ECOG performance status ≤ 2
- Subjects must have normal organ and marrow function as defined: Leukocytes ≥4,000/mcL; Absolute neutrophil count ≥1,500/mcL; Platelets ≥100,000/mcL; Total bilirubin ≤1.5 times the upper limit of normal; Creatinine clearance ≥25 mL/min/1.73 m2
- Negative serum or urine pregnancy test prior to enrollment for women of childbearing age and potential.
- The effects of radiation on the developing human fetus are not well described. For this reason, women of child-bearing potential and non-sterilized men who are sexually active with a woman of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Must be considered a candidate for durvalumab, per the treating investigator
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
Subjects must not meet any of the following criteria.
- Subjects who have had prior systemic therapy for lung cancer
- Subjects who have had prior radiation to the region of the chest that would result in overlap of radiation therapy fields and determined by the treating physician to impede the treatment of the study malignancy.
- Subjects who are actively being treated on any other interventional research study.
- Prior invasive malignancy unless disease free for a minimum of 3 years from enrollment. However, non-melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the breast, oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the subject according to the treating investigator is permissible.
- Centrally located primary tumor < 2 cm from involved nodal disease which would result in significant overlap of radiation dose. Centrally located is defined as within or touching the zone of the proximal bronchial tree, which is a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy
|
Primary tumor SBRT
concurrent chemotherapy
concurrent chemotherapy
concurrent chemotherapy
concurrent chemotherapy
mediastinal radiation
adjuvant immunotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
12-Month Progression Free Survival
Time Frame: 12 months
|
Progression-free survival (PFS) will be determined for each subject as a binary variable indicating whether or not the subject is alive and progression free at 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: 5 years
|
Progression free survival (PFS) is defined as the duration of time from enrollment to the study to first occurrence of either progressive disease or death.
|
5 years
|
Overall survival (OS)
Time Frame: 5 years
|
Overall survival (OS) is defined as the duration of time from the date of enrollment to the study to the date of death from any cause.
|
5 years
|
Radiologic clinical complete response
Time Frame: 3 months
|
Radiologic clinical complete response will be recorded for each subject as a binary variable indicating whether or not the subject had no evidence of disease on PET/CT or CT scan approximately 3 months after the last treatment of concurrent mediastinal chemoradiation.
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3 months
|
Objective Response
Time Frame: 3 months
|
Objective response will be determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of Complete Response (CR) or Partial Response (PR).
|
3 months
|
Local Control
Time Frame: 12 and 24 months
|
Local control (LC) is defined as the duration of time from enrollment to the study to first progression of the subject's primary lesions(s).
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12 and 24 months
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Regional Control
Time Frame: 12 and 24 months
|
Regional control (RC) is defined as the duration of time from enrollment to the study to first progression of the subject's regional lesion(s).
|
12 and 24 months
|
Locoregional Control
Time Frame: 12 and 24 months
|
Locoregional control is defined as the duration of time from enrollment to the study to first progression of the subject's local and/or regional lesion(s), whichever occurs first.
|
12 and 24 months
|
Distant Control
Time Frame: 12 and 24 months
|
Distant control defined as the duration of time from enrollment to the study to first metastatic progression.
|
12 and 24 months
|
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Score
Time Frame: pre-SBRT, post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation
|
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients.
Using linear transformation, raw scores are standardized, so that scores range from 0 to 100.
A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms.
|
pre-SBRT, post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation
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Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Score
Time Frame: pre-SBRT, post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation
|
The QLQ-LC13 includes questions assessing lung cancer associated symptoms, treatment related side effects and pain medication.
Using linear transformation, raw scores are standardized, so that scores range from 0 to 100.
A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms.
|
pre-SBRT, post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation
|
Change from Baseline in MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Score
Time Frame: pre-SBRT, post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation
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The MDASI-LC Module includes 22 questions to assess the severity of multiple lung cancer-related symptoms and the impact of these symptoms on daily functioning.
Scores for each item range from 0 to 10, where 0 indicates no symptoms and 10 indicates worst possible symptoms.
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pre-SBRT, post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Grade 2 or higher adverse events of special interest
Time Frame: up to 6 months post-SBRT
|
Toxicities will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Toxicities will be tabulated by type and grade separately for each phase of treatment.
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up to 6 months post-SBRT
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John H Heinzerling, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 12, 2017
Primary Completion (Actual)
July 12, 2023
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
May 3, 2017
First Submitted That Met QC Criteria
May 3, 2017
First Posted (Actual)
May 5, 2017
Study Record Updates
Last Update Posted (Estimated)
April 15, 2024
Last Update Submitted That Met QC Criteria
April 11, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Carboplatin
- Etoposide
- Paclitaxel
- Cisplatin
- Durvalumab
Other Study ID Numbers
- IRB00081382
- 00021247 (Other Identifier: Advarra IRB)
- LCI-LUN-NSC-SBRT-001 (Other Identifier: Atrium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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