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| ID | Type | Description | Link |
|---|---|---|---|
| 00021247 | Other Identifier | Advarra IRB | |
| LCI-LUN-NSC-SBRT-001 | Other Identifier | Atrium |
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
| AstraZeneca | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | Primary tumor SBRT |
| |
| Carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Progression Free and Surviving at 12 Months | 12-month progression free survival was determined for each subject as a binary variable indicating whether or not the subject was progression free and surviving at 12 months after study enrollment. Failure occurred if the subject progressed or died from any cause within 12 months of study enrollment. Disease progression was determined according to RECIST v1.1. | From date of treatment start to date of progression or death, or censored at 12 months, whichever occurred first. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death. PD must be objectively determined per RECIST v1.1 criteria, where progression date is date of last radiologic assessment that identified PD. If subject died without documented PD, progression date will be death date. For surviving subjects who do not have PD, PFS will be censored at the date of last radiologic assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS will be censored at the date of last radiologic assessment prior to commencement of subsequent therapy. Subjects who have an initial PFS event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 2 or Higher Radiation Pneumonitis | A binary variable will be determined for each subject indicating whether or not the subject experienced at least one grade 2 or higher pneumonitis adverse event according to the NCI Common Terminology for Adverse Events version 4.0 during induction. Pneumonitis events receiving treatment with steroids and possibly, probably, or definitely attributed to SBRT or mediastinal radiation will be included. |
Inclusion Criteria
Subjects must meet all the following criteria:
Exclusion Criteria
Subjects must not meet any of the following criteria.
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| Name | Affiliation | Role |
|---|---|---|
| John H Heinzerling | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39615497 | Derived | Heinzerling JH, Mileham KF, Robinson MM, Symanowski JT, Induru RR, Brouse GM, Corso CD, Prabhu RS, Haggstrom DE, Moeller BJ, Bobo WE, Fasola CE, Thakkar VV, Pal SE, Gregory JM, Norek SL, Begic XJ, Kesarwala AH, Burri SH, Simone CB 2nd. Primary lung tumour stereotactic body radiotherapy followed by concurrent mediastinal chemoradiotherapy and adjuvant immunotherapy for locally advanced non-small-cell lung cancer: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2025 Jan;26(1):85-97. doi: 10.1016/S1470-2045(24)00573-4. Epub 2024 Nov 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy | SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy SBRT: Primary tumor stereotactic body radiation therapy (SBRT) Concurrent chemotherapy: (Carboplatin + Paclitaxel) or (cis Platinum + Etoposide) Mediastinal radiation: intensity-modulated radiation therapy (IMRT) Adjuvant immunotherapy: durvalumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2023 |
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| Drug |
concurrent chemotherapy |
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| Paclitaxel | Drug | concurrent chemotherapy |
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| cis Platinum | Drug | concurrent chemotherapy |
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| Etoposide | Drug | concurrent chemotherapy |
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| IMRT | Radiation | mediastinal radiation |
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| Durvalumab | Drug | adjuvant immunotherapy |
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| From date of treatment start to date of progression or death, or censored as described; assessed for approximately 5 years |
| Overall Survival (OS) | OS is defined as the duration from enrollment to the study (treatment start date) to the date of death from any cause. Participants who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive. | From date of treatment start to date of death, or censored as described; assessed for approximately 5 years |
| Radiologic Clinical Complete Response | 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 either PET/CT or CT scan approximately 3 months after the last treatment of concurrent mediastinal chemoradiation. | Approximately 3 months after last treatment of concurrent mediastinal chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) |
| Number of Participants With an Objective Response | Objective response is determined for each participant as a binary variable indicating whether or not the participant achieved a best overall response of complete response (CR) or partial response (PR) as determined by RECIST v1.1 criteria. | From enrollment to best response while on study treatment; participants remained on study treatment (including SBRT, chemoradiation, and durvalumab) 4.5 months on average. |
| Local Control at 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). If a participant dies prior to local progression local control will be censored at the date of death. For surviving subjects with no documented local progression, local control will be censored at the date of the last radiologic assessment that evaluated the local tumor(s). For subjects who receive subsequent anticancer therapy prior to documented local progression, local control will be censored at the date of last radiologic assessment that evaluated the local tumor(s) prior to the commencement of subsequent therapy. Local control will be estimated at 12 and 24 months. | From date of treatment start to date of progression of primary lesion or censored as described; assessed for approximately 2 years.] |
| Regional Control at 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 lesions(s). If a participant dies prior to regional progression regional control will be censored at the date of death. For surviving subjects with no documented regional progression, regional control will be censored at the date of the last radiologic assessment that evaluated the regional tumor(s). For subjects who receive subsequent anticancer therapy prior to documented regional progression, regional control will be censored at the date of last radiologic assessment that evaluated the regional tumor(s) prior to the commencement of subsequent therapy. Regional control will be estimated at 12 and 24 months. | From date of treatment start to date of progression of regional lesions or censored as described; assessed for approximately 2 years. |
| Locoregional Control at 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 lesions(s), whichever occurs first. If a participant dies prior to locoregional progression locoregional control will be censored at the date of death. For surviving subjects with no documented local and/or regional progression, locoregional control will be censored at the date of the last radiologic assessment that evaluated the local and regional lesion(s). For subjects who receive subsequent anticancer therapy prior to documented locoregional progression, locoregional control will be censored at the date of last radiologic assessment that evaluated the local and regional tumor(s) prior to the commencement of subsequent therapy. Locoregional control will be estimated at 12 and 24 months. | From date of treatment start to date of progression of primary or regional lesions or censored as described; assessed for approximately 2 years. |
| Distant Control at 12 and 24 Months | Distant control defined as the duration of time from enrollment to first metastatic progression. If a subject dies prior to metastatic progression, distant control will be censored at the date of death. For surviving subjects with no documented metastatic progression, distant control will be censored at the date of the last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented metastatic progression, distant control will be censored at the date of last radiologic assessment prior to the commencement of subsequent therapy. Distant control will be estimated at 12 and 24 months. | From date of treatment start to date of metastatic progression or censored as described; assessed for approximately 2 years |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Score | The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. EORTC QLQ-C30 includes 5 functional scales, 9 symptom scales/items, and a global health status/quality of life (QoL) scale. The global health status/QoL score is determined from two 7-point items, ranging from 1 (Very Poor) to 7 (Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score represents a higher (better) quality of life. | baseline (pre-SBRT), post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Lung Cancer (EORTC QLQ-LC13) Symptom Scores | The EORTC QLQ-LC13 is a 13-item questionnaire to assess lung cancer associated symptoms, treatment related side effects and pain medication. Both multi-item and single-item measures of lung-cancer associated symptoms and side-effects from conventional chemo and radiotherapy. We focused on 3 symptoms of interest from the EORTC QLQ-LC13: dyspnoea, coughing, and dysphagia. Dyspnoea is a function of three items and can only be determined if all three items have been answered, while coughing and dysphagia are single-item symptoms. Each symptom score is determined by averaging the items that contribute to the scale to get a raw score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher symptom score represents a higher (worse) level of symptoms. | baseline (pre-SBRT), post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) |
| MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Total Symptom + Interference Score | 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. Arithmetic mean of the items completed was calculated to determine a mean total symptom + interference score ranging from 0 to 10. The mean score is reported if more than 50% of the items are completed on a given administration. Higher scores indicate worse symptoms and more interference. | baseline (pre-SBRT), post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) |
| From enrollment to 6 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 8 months). |
| Number of Participants With Grade 3 or Higher Pulmonary Events | A binary variable will be determined for each subject indicating whether or not the subject experienced at least one grade 3 or higher pulmonary adverse event according to the NCI Common Terminology for Adverse Events version 4.0 during induction. This includes pulmonary adverse events regardless of attribution. | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). |
| Number of Participants With at Least One Serious Event | A binary variable will be determined for each participant indicating whether or not the subject had at least one adverse event that was categorized as serious, regardless of causality. Serious is defined per the study protocol and includes events that the investigator deems serious and results in the following outcomes: death, life-threatening situation, persistent or significant disability/incapacity, requires or prolongs hospitalization, congenital anomaly/birth defect in the offspring of a study participant, suspected transmission of any infections agent via medical product, or based upon medical judgement, may jeopardize the subject and may require medical or surgical intervention to prevent one of the afore listed outcomes from occurring. | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). |
| Number of Participants With at Least One Treatment Emergent Adverse Event | A binary variable will be determined for each participant indicating whether or not the subject had at least one treatment-emergent adverse event, regardless of causality. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 4.0. Treatment-emergent is defined per the study protocol and includes AEs that occur after treatment start that were not present at the time of treatment start or AEs that increase in severity after treatment start if the event was present at the time of treatment start. | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). |
| Number of Participants With at Least One Grade 3 or Higher Treatment Emergent Adverse Event | A binary variable will be determined for each participant indicating whether or not the subject had at least one grade 3 or higher treatment-emergent adverse event, regardless of causality. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 4.0. Treatment-emergent is defined per the study protocol and includes AEs that occur after treatment start that were not present at the time of treatment start or AEs that increase in severity after treatment start if the event was present at the time of treatment start. | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). |
| Number of Participants Who Discontinued Study Treatment Due to Adverse Events | A binary variable will be determined for each participant indicating whether or not the subject discontinued study treatment due to adverse events. | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months) |
| Number of Participants Who Received Durvalumab | A binary variable will be determined for each participant indicating whether or not the subject received at least one dose of durvalumab on study | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy | SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy SBRT: Primary tumor stereotactic body radiation therapy (SBRT) Concurrent chemotherapy: (Carboplatin + Paclitaxel) or (cis Platinum + Etoposide) Mediastinal radiation: intensity-modulated radiation therapy (IMRT) Adjuvant immunotherapy: durvalumab |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Progression Free and Surviving at 12 Months | 12-month progression free survival was determined for each subject as a binary variable indicating whether or not the subject was progression free and surviving at 12 months after study enrollment. Failure occurred if the subject progressed or died from any cause within 12 months of study enrollment. Disease progression was determined according to RECIST v1.1. | The population evaluable for the 12-month PFS outcome is defined as all subjects who initiate treatment with SBRT and experienced a PFS event within 12 months of enrollment or have at least one year of radiologic follow-up from enrollment. | Posted | Count of Participants | Participants | From date of treatment start to date of progression or death, or censored at 12 months, whichever occurred first. |
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| Secondary | Progression Free Survival (PFS) | PFS is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death. PD must be objectively determined per RECIST v1.1 criteria, where progression date is date of last radiologic assessment that identified PD. If subject died without documented PD, progression date will be death date. For surviving subjects who do not have PD, PFS will be censored at the date of last radiologic assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS will be censored at the date of last radiologic assessment prior to commencement of subsequent therapy. Subjects who have an initial PFS event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments. | Not Posted | Jul 2027 | From date of treatment start to date of progression or death, or censored as described; assessed for approximately 5 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the duration from enrollment to the study (treatment start date) to the date of death from any cause. Participants who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive. | Not Posted | Jul 2027 | From date of treatment start to date of death, or censored as described; assessed for approximately 5 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Radiologic Clinical Complete Response | 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 either PET/CT or CT scan approximately 3 months after the last treatment of concurrent mediastinal chemoradiation. | Defined as all subjects who initiate treatment with SBRT and who have PET/CT results at approximately 3 months after last treatment of concurrent mediastinal chemoradiation. | Posted | Count of Participants | Participants | Approximately 3 months after last treatment of concurrent mediastinal chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) |
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| Secondary | Number of Participants With an Objective Response | Objective response is determined for each participant as a binary variable indicating whether or not the participant achieved a best overall response of complete response (CR) or partial response (PR) as determined by RECIST v1.1 criteria. | The response evaluable population is defined as all subjects who initiate treatment with SBRT and who have measurable disease present at baseline. | Posted | Count of Participants | Participants | From enrollment to best response while on study treatment; participants remained on study treatment (including SBRT, chemoradiation, and durvalumab) 4.5 months on average. |
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| Secondary | Local Control at 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). If a participant dies prior to local progression local control will be censored at the date of death. For surviving subjects with no documented local progression, local control will be censored at the date of the last radiologic assessment that evaluated the local tumor(s). For subjects who receive subsequent anticancer therapy prior to documented local progression, local control will be censored at the date of last radiologic assessment that evaluated the local tumor(s) prior to the commencement of subsequent therapy. Local control will be estimated at 12 and 24 months. | Not Posted | Jul 2027 | From date of treatment start to date of progression of primary lesion or censored as described; assessed for approximately 2 years.] | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Regional Control at 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 lesions(s). If a participant dies prior to regional progression regional control will be censored at the date of death. For surviving subjects with no documented regional progression, regional control will be censored at the date of the last radiologic assessment that evaluated the regional tumor(s). For subjects who receive subsequent anticancer therapy prior to documented regional progression, regional control will be censored at the date of last radiologic assessment that evaluated the regional tumor(s) prior to the commencement of subsequent therapy. Regional control will be estimated at 12 and 24 months. | Not Posted | Jul 2027 | From date of treatment start to date of progression of regional lesions or censored as described; assessed for approximately 2 years. | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Locoregional Control at 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 lesions(s), whichever occurs first. If a participant dies prior to locoregional progression locoregional control will be censored at the date of death. For surviving subjects with no documented local and/or regional progression, locoregional control will be censored at the date of the last radiologic assessment that evaluated the local and regional lesion(s). For subjects who receive subsequent anticancer therapy prior to documented locoregional progression, locoregional control will be censored at the date of last radiologic assessment that evaluated the local and regional tumor(s) prior to the commencement of subsequent therapy. Locoregional control will be estimated at 12 and 24 months. | Not Posted | Jul 2027 | From date of treatment start to date of progression of primary or regional lesions or censored as described; assessed for approximately 2 years. | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Distant Control at 12 and 24 Months | Distant control defined as the duration of time from enrollment to first metastatic progression. If a subject dies prior to metastatic progression, distant control will be censored at the date of death. For surviving subjects with no documented metastatic progression, distant control will be censored at the date of the last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented metastatic progression, distant control will be censored at the date of last radiologic assessment prior to the commencement of subsequent therapy. Distant control will be estimated at 12 and 24 months. | Not Posted | Jul 2027 | From date of treatment start to date of metastatic progression or censored as described; assessed for approximately 2 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Score | The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. EORTC QLQ-C30 includes 5 functional scales, 9 symptom scales/items, and a global health status/quality of life (QoL) scale. The global health status/QoL score is determined from two 7-point items, ranging from 1 (Very Poor) to 7 (Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score represents a higher (better) quality of life. | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Posted | Least Squares Mean | Standard Error | score on a scale | baseline (pre-SBRT), post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) |
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| Secondary | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Lung Cancer (EORTC QLQ-LC13) Symptom Scores | The EORTC QLQ-LC13 is a 13-item questionnaire to assess lung cancer associated symptoms, treatment related side effects and pain medication. Both multi-item and single-item measures of lung-cancer associated symptoms and side-effects from conventional chemo and radiotherapy. We focused on 3 symptoms of interest from the EORTC QLQ-LC13: dyspnoea, coughing, and dysphagia. Dyspnoea is a function of three items and can only be determined if all three items have been answered, while coughing and dysphagia are single-item symptoms. Each symptom score is determined by averaging the items that contribute to the scale to get a raw score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher symptom score represents a higher (worse) level of symptoms. | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Posted | Least Squares Mean | Standard Error | score on a scale | baseline (pre-SBRT), post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) |
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| Secondary | MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Total Symptom + Interference Score | 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. Arithmetic mean of the items completed was calculated to determine a mean total symptom + interference score ranging from 0 to 10. The mean score is reported if more than 50% of the items are completed on a given administration. Higher scores indicate worse symptoms and more interference. | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Posted | Least Squares Mean | Standard Error | score on a scale | baseline (pre-SBRT), post-SBRT/pre-chemoradiation, and 1, 3, 6, and 12 months after the last treatment of chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline) |
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| Other Pre-specified | Number of Participants With Grade 2 or Higher Radiation Pneumonitis | A binary variable will be determined for each subject indicating whether or not the subject experienced at least one grade 2 or higher pneumonitis adverse event according to the NCI Common Terminology for Adverse Events version 4.0 during induction. Pneumonitis events receiving treatment with steroids and possibly, probably, or definitely attributed to SBRT or mediastinal radiation will be included. | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Posted | Count of Participants | Participants | From enrollment to 6 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 8 months). |
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| Other Pre-specified | Number of Participants With Grade 3 or Higher Pulmonary Events | A binary variable will be determined for each subject indicating whether or not the subject experienced at least one grade 3 or higher pulmonary adverse event according to the NCI Common Terminology for Adverse Events version 4.0 during induction. This includes pulmonary adverse events regardless of attribution. | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Posted | Count of Participants | Participants | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). |
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| Other Pre-specified | Number of Participants With at Least One Serious Event | A binary variable will be determined for each participant indicating whether or not the subject had at least one adverse event that was categorized as serious, regardless of causality. Serious is defined per the study protocol and includes events that the investigator deems serious and results in the following outcomes: death, life-threatening situation, persistent or significant disability/incapacity, requires or prolongs hospitalization, congenital anomaly/birth defect in the offspring of a study participant, suspected transmission of any infections agent via medical product, or based upon medical judgement, may jeopardize the subject and may require medical or surgical intervention to prevent one of the afore listed outcomes from occurring. | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Posted | Count of Participants | Participants | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). |
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| Other Pre-specified | Number of Participants With at Least One Treatment Emergent Adverse Event | A binary variable will be determined for each participant indicating whether or not the subject had at least one treatment-emergent adverse event, regardless of causality. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 4.0. Treatment-emergent is defined per the study protocol and includes AEs that occur after treatment start that were not present at the time of treatment start or AEs that increase in severity after treatment start if the event was present at the time of treatment start. | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Posted | Count of Participants | Participants | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). |
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| Other Pre-specified | Number of Participants With at Least One Grade 3 or Higher Treatment Emergent Adverse Event | A binary variable will be determined for each participant indicating whether or not the subject had at least one grade 3 or higher treatment-emergent adverse event, regardless of causality. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 4.0. Treatment-emergent is defined per the study protocol and includes AEs that occur after treatment start that were not present at the time of treatment start or AEs that increase in severity after treatment start if the event was present at the time of treatment start. | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Posted | Count of Participants | Participants | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). |
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| Other Pre-specified | Number of Participants Who Discontinued Study Treatment Due to Adverse Events | A binary variable will be determined for each participant indicating whether or not the subject discontinued study treatment due to adverse events. | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Posted | Count of Participants | Participants | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months) |
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| Other Pre-specified | Number of Participants Who Received Durvalumab | A binary variable will be determined for each participant indicating whether or not the subject received at least one dose of durvalumab on study | The evaluable population is defined as all subjects who initiate treatment with SBRT. | Posted | Count of Participants | Participants | Assessed for approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months). |
|
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From enrollment, during treatment, until approximately 12 months after last treatment of concurrent mediastinal chemoradiation (on average, a total of 14 months).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy | SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy SBRT: Primary tumor stereotactic body radiation therapy (SBRT) Concurrent chemotherapy: (Carboplatin + Paclitaxel) or (cis Platinum + Etoposide) Mediastinal radiation: intensity-modulated radiation therapy (IMRT) Adjuvant immunotherapy: durvalumab | 32 | 61 | 23 | 61 | 61 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | COPD exacerbation |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Asthma exacerbation |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac disorders - Other | Cardiac disorders | CTCAE (4.0) | Systematic Assessment | CHF exacerbation |
|
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders and administration site conditions | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders and administration site conditions | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General disorders and administration site conditions | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders and administration site conditions | CTCAE (4.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | COPD exacerbation |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | hemoptysis |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction | General disorders and administration site conditions | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chair of Biostatistics Department | Atrium Health Levine Cancer | 9804422371 | james.symanowski@atriumhealth.org |
| Jun 25, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2022 | Jan 27, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| C000613593 | durvalumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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