Trial · NCT03811002
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months. | Survival rates and median survival time are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. |
| Secondary | Progression Free Survival (PFS) | From randomization to progression or death due to any cause, whichever occurs first, or last tumor assessment if alive. MMedian follow-up at the time of analysis was 23.8 months. | PFS failure event is defined as progressive disease (PD) determined by investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause. PD is defined as at least a 20% increase in the sum of longest diameters of target lesions, and an absolute increase of at least 5 mm. The appearance of any new lesions is also considered progression. PFS rates and median PFS time are estimated using the Kaplan-Meier method, censoring participants alive without progression at the date of their last evaluable radiographic tumor assessment. |
| Secondary | Number of Participants by Highest Grade Adverse Event Reported | Randomization to last follow-up. Median follow-up at the time of analysis was 23.8 months. | Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
| Secondary | Percentage of Participants With Confirmed Objective Response (Objective Response Rate (ORR)) | Randomization to last radiographic tumor assessment. Median follow-up at the time of analysis was 23.8 months. | Objective response rate (ORR) is defined as the proportion of subjects whose best overall response (BOR) is a confirmed complete or partial response as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 on two consecutive occasions ≥4 weeks apart. |
| Secondary | Percentage of Participants With Local Progression | From randomization to local progression, other progression, or death, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months. 1-, 2-, and 3-year rates are reported. | Local progression is defined as intrathoracic tumor progression (failure in the lobe of the primary tumor or mediastinal lymph nodes) by RECIST 1.1 criteria determined by the investigator. Local progression rates are estimated by the cumulative incidence method, treating non-local progression (i.e., distant metastasis or failure in a different lung) and death without local progression as competing risks, and otherwise censoring participants alive at last tumor assessment. Treatment effect comparisons will utilize a cause-specific hazard function in which competing risks are censored. |
| Secondary | Distant Metastases-free Survival (DMFS) | Randomization to DMFS event or local progression, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months. | DMFS failure event is defined as first date of documented distant metastases (or failures in a different lung lobe) or death due to any cause, whichever occurs first. Participants with local progression prior to such an event are censored on the date of local progression. Participants with no post-baseline tumor assessment and alive at last follow-up are censored on the date of randomization. Participants alive without distant metastasis, failures in a different lung lobe, or local progression are censored on the date of their last evaluable radiographic tumor assessment. DMFS rates and median DMFS time are estimated using the Kaplan-Meier method. |
| Secondary | Percent of Participants With Deterioration in Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI) | Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization) | FACT-TOI is a measure of 21 items that sums the functional well-being (FWB), physical well-being (PWB), and the lung cancer subscale (LCS) of the Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life (QOL) instrument. The FACT-TOI total score ranges from 0 to 84 with higher scores indicating better quality of life and functioning. Clinically meaningful decline is defined as a decrease from baseline of at least 5 points. |
| Secondary | Quality-adjusted Survival Months | Baseline to death, last follow-up or two years, whichever occurs first. | Quality-adjusted survival is calculated as the sum of weighted time intervals. Weight is the EuroQol 5-dimensional 5-level (EQ-5d-5L) index score, which measures health-related quality of life and ranges from 0 (death) to 1 (full health). |
| Secondary | Change From Baseline in the 7 Item Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score | Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization) | The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue. |
| Secondary | Molecular Subtyping | Up to 5 years | |
| Other | Patient-reported Symptomatic Toxicities | Up to 15 months after completion of chemoradiation therapy | Will be measured by Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE). For each symptom and each domain (i.e., frequency, severity, and interference), counts and frequencies will be summarized for the worst score experienced by the patient by treatment arm. |
| Other | Concordance Between Tumor and Circulating Cell Free Deoxyribonucleic Acid (cfDNA) Molecular Subtypes | Up to 5 years | The concordance between molecular subtypes obtained via ribonucleic acid sequencing (RNAseq) on tumor tissue and methylation analysis on cfDNA will be assessed among patients who have both evaluable RNAseq and methylation results, where Cohen's Kappa and corresponding 95% confidence interval will be reported. In addition, the sensitivity and specificity of dichotomized cfDNA molecular subtypes (considering RNAseq as reference standard), along with the associated 95% confidence intervals, will be reported. Spearman rank correlation and associated 95% confidence intervals based on bootstrap between RNAseq and methylation will be reported. |
| Other | Overall Survival by Sex | Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months. | NIH-required analysis. Survival rates and median survival time are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. |
| Other | Overall Survival by Ethnicity | Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months. | NIH-required analysis. Survival rates and median survival time are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. |
| Other | Overall Survival by Race | Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months. | NIH-required analysis. Survival rates and median survival time are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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