Trial Outcomes & Findings for Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC (NCT NCT03141359)

Last Updated: 2026-02-05

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

From date of treatment start to date of progression or death, or censored at 12 months, whichever occurred first.

Results posted on

2026-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	61
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	61

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Death	32
Overall Study Still On Study (in follow up)	29

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy n=61 Participants 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
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=25 Participants
Age, Categorical >=65 years	40 Participants n=25 Participants
Age, Continuous	67 years n=25 Participants
Sex: Female, Male Female	28 Participants n=25 Participants
Sex: Female, Male Male	33 Participants n=25 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=25 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=25 Participants
Race (NIH/OMB) Asian	1 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	7 Participants n=25 Participants
Race (NIH/OMB) White	51 Participants n=25 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=25 Participants
Region of Enrollment United States	61 participants n=25 Participants

PRIMARY outcome

Timeframe: From date of treatment start to date of progression or death, or censored at 12 months, whichever occurred first.

Population: 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.

Outcome measures

Outcome measures
Measure	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy n=59 Participants 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
Number of Participants Progression Free and Surviving at 12 Months	37 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 3 months after last treatment of concurrent mediastinal chemoradiation (on average, SBRT plus chemoradiation treatment lasted 2 months from baseline)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy n=49 Participants 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
Radiologic Clinical Complete Response	28 Participants

SECONDARY outcome

Timeframe: From enrollment to best response while on study treatment; participants remained on study treatment (including SBRT, chemoradiation, and durvalumab) 4.5 months on average.

Population: The response evaluable population is defined as all subjects who initiate treatment with SBRT and who have measurable disease present at baseline.

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.

Outcome measures

Outcome measures
Measure	SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy n=60 Participants 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
Number of Participants With an Objective Response	45 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)