Trial · NCT04194944
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease. |
| Primary | PFS by BICR (With or Without Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease. |
| Secondary | Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | DCR by BICR (with Pembrolizumab) is defined as the number of participants who achieve a BOR of complete response (CR), partial response (PR), or stable disease (SD) lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm. |
| Secondary | Percentage of Participant With DCR by BICR (With or Without Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | DCR by BICR (with or without Pembrolizumab) is defined as the number of participants who achieve a BOR of CR, PR, or SD lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm. |
| Secondary | PFS2 (With Pembrolizumab) | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months | PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression. |
| Secondary | PFS2 (With or Without Pembrolizumab) | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months | PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression. |
| Secondary | Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR (With Pembrolizumab) | Baseline through Disease Progression or Death Up to 31 Months | ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm. |
| Secondary | ORR: Percentage of Participants With CR or PR by BICR (With or Without Pembrolizumab) | Baseline through Disease Progression or Death Up to 31 Months | ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm. |
| Secondary | Duration of Response (DoR) by BICR (With Pembrolizumab) | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria. |
| Secondary | DOR by BICR (With or Without Pembrolizumab) | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria. |
| Secondary | Overall Survival (OS) (With Pembrolizumab) | Baseline to Date of Death from Any Cause Up to 38 Months | Overall survival was defined as the time from randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data was censored on the last date the participant is known to be alive. |
| Secondary | OS (With or Without Pembrolizumab) | Baseline to Date of Death from Any Cause Up to 38 Months | Overall survival was defined as the time from randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. |
| Secondary | Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 by BICR (With Pembrolizumab) | Baseline through Central Nervous System (CNS) Progression or Death up to 31 Months | Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with Pembrolizumab) |
| Secondary | Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST 1.1 by BICR (With or Without Pembrolizumab) | Baseline through CNS Progression or Death Up to 31 Months | Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab) |
| Secondary | Median Intracranial DOR Per RECIST 1.1 by BICR (With Pembrolizumab) | Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months | Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab) |
| Secondary | Median Intracranial DOR Per RECIST 1.1 by BICR (With or Without Pembrolizumab) | Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months | Median Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab) |
| Secondary | Time to Deterioration of Pulmonary Symptoms (With Pembrolizumab) | Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months | Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-Symptom Assessment Questionnaire (SAQ) (with Pembrolizumab) |
| Secondary | Time to Deterioration of Pulmonary Symptoms (With or Without Pembrolizumab) | Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months | Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-SAQ (with or without Pembrolizumab) |
| Secondary | The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants With RET-Positive Specimens as Called by the Central Lab, Which is Also RET-Positive as Called by a Local Lab (Positive Percent Agreement) | Baseline | The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement) |
| Secondary | Median Time to CNS Progression Per RECIST 1.1 by BICR (With Pembrolizumab) | Baseline through CNS Progression or Death Up to 31 Months | Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab) |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04194944/registered