Trial · NCT03141359

Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC

NCT03141359, Phase 2, Active not recruiting, Wake Forest University Health Sciences; results first posted 2024-08-29

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC. Trials, record NCT03141359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03141359

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC
NCT number: NCT03141359
Status: Active not recruiting
Phases: Phase 2
Enrollment: 61 participants, actual
Lead sponsor: Wake Forest University Health Sciences
Conditions: Lung Cancer Stage II, Lung Cancer Stage III, Non Small Cell Lung Cancer
Interventions: SBRT, Carboplatin, Paclitaxel, cis Platinum, Etoposide, IMRT, Durvalumab
First posted: 2017-05-05
Last updated: 2026-07-28
Results first posted: 2024-08-29

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Progression Free and Surviving at 12 Months	From date of treatment start to date of progression or death, or censored at 12 months, whichever occurred first.	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.
Secondary	Progression Free Survival (PFS)	From date of treatment start to date of progression or death, or censored as described; assessed for approximately 5 years	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.
Secondary	Overall Survival (OS)	From date of treatment start to date of death, or censored as described; assessed for approximately 5 years	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.
Secondary	Radiologic Clinical Complete Response	Approximately 3 months after last treatment of concurrent mediastinal chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline)	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.
Secondary	Number of Participants With an Objective Response	From enrollment to best response while on study treatment; participants remained on study treatment (including SBRT, chemoradiation, and durvalumab) 4.5 months on average.	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.
Secondary	Local Control 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.]	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.
Secondary	Regional Control 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.	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.
Secondary	Locoregional Control 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.	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.
Secondary	Distant Control at 12 and 24 Months	From date of treatment start to date of metastatic progression or censored as described; assessed for approximately 2 years	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.
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	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)	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.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Progression Free and Surviving at 12 Months	From date of treatment start to date of progression or death, or censored at 12 months, whichever occurred first.	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression Free Survival (PFS)	From date of treatment start to date of progression or death, or censored as described; assessed for approximately 5 years
SECONDARY	Overall Survival (OS)	From date of treatment start to date of death, or censored as described; assessed for approximately 5 years
SECONDARY	Radiologic Clinical Complete Response	Approximately 3 months after last treatment of concurrent mediastinal chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline)	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With an Objective Response	From enrollment to best response while on study treatment; participants remained on study treatment (including SBRT, chemoradiation, and durvalumab) 4.5 months on average.	The response evaluable population is defined as all subjects who initiate treatment with SBRT and who have measurable disease present at baseline.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Local Control 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.]
SECONDARY	Regional Control 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.
SECONDARY	Locoregional Control 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.
SECONDARY	Distant Control at 12 and 24 Months	From date of treatment start to date of metastatic progression or censored as described; assessed for approximately 2 years
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	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)	The evaluable population is defined as all subjects who initiate treatment with SBRT.	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants Progression Free and Surviving at 12 Months	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy		37		Participants
Radiologic Clinical Complete Response	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy		28		Participants
Number of Participants With an Objective Response	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy		45		Participants
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	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	Baseline	66.25	Standard Error 2.80	score on a scale
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	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	Post-SBRT	62.00	Standard Error 2.80	score on a scale
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	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	1 month after Chemoradiation	65.46	Standard Error 2.90	score on a scale
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	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	3 months after Chemoradiation	64.27	Standard Error 2.92	score on a scale
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	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	6 months after Chemoradiation	64.43	Standard Error 3.09	score on a scale
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	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	12 months after Chemoradiation	60.99	Standard Error 3.44	score on a scale
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Lung Cancer (EORTC QLQ-LC13) Symptom Scores	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	Dyspnoea - Baseline	25.64	Standard Error 2.97	score on a scale

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	61
Overall Study	COMPLETED	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	0
Overall Study	NOT COMPLETED	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	61

Source ClinicalTrials.gov

Adverse events83

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Esophagitis	Gastrointestinal disorders	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	37	61
other	Fatigue	General disorders and administration site conditions	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	35	61
other	Nausea	Gastrointestinal disorders	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	24	61
other	Dysphagia	Gastrointestinal disorders	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	23	61
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	22	61
other	Anorexia	Metabolism and nutrition disorders	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	21	61
other	Diarrhea	Gastrointestinal disorders	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	21	61
other	Constipation	Gastrointestinal disorders	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	17	61
other	Cough	Respiratory, thoracic and mediastinal disorders	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	16	61
other	Pneumonitis	Respiratory, thoracic and mediastinal disorders	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	16	61

1 to 10 of 83Source ClinicalTrials.gov

See all 83 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	32	61
Total, other adverse events	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	61	61
Total, serious adverse events	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy	23	61

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39615497	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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