Trial · NCT04194944
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Intent to Treat (ITT) Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 80, TRT B: 34. | Months | MEDIAN |
| PRIMARY | PFS by BICR (With or Without Pembrolizumab) | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 98, TRT B:45. | Months | MEDIAN |
| 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 | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. | Percentage of Participants | NUMBER |
| 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 | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Percentage of Participants | NUMBER |
| SECONDARY | PFS2 (With Pembrolizumab) | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 103; TRT B: 62 | Months | MEDIAN |
| SECONDARY | PFS2 (With or Without Pembrolizumab) | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 126; TRT B: 77 | Months | MEDIAN |
| 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 | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. | Percentage of participants | NUMBER |
| 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 | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Percentage of Participants | NUMBER |
| 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 | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A:74; TRT B: 25. | Months | MEDIAN |
| 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 | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 90; TRT B: 33. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) (With Pembrolizumab) | Baseline to Date of Death from Any Cause Up to 38 Months | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 104; TRT B: 68. | Months | MEDIAN |
| SECONDARY | OS (With or Without Pembrolizumab) | Baseline to Date of Death from Any Cause Up to 38 Months | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 127; TRT B: 84. | Months | MEDIAN |
| 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 | CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline. | Percentage of participants | NUMBER |
| 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 | CNS Overall: All participants included in the ITT population who had baseline CNS assessment and who had CNS metastasis at baseline. | Percentage of participants | NUMBER |
| 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 | CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline. Participants censored: TRT A: 13; TRT B: 9. | Months | MEDIAN |
| 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 | CNS Overall: All participants included in the ITT population who had baseline CNS assessment and who had CNS metastasis at baseline. Participants censored: TRT A: 15; TRT B: 9. | Months | MEDIAN |
| SECONDARY | Time to Deterioration of Pulmonary Symptoms (With Pembrolizumab) | Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 99; TRT B: 47. | Months | MEDIAN |
| SECONDARY | Time to Deterioration of Pulmonary Symptoms (With or Without Pembrolizumab) | Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 121; TRT B: 58. | Months | MEDIAN |
| 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 | |||
| SECONDARY | Median Time to CNS Progression Per RECIST 1.1 by BICR (With Pembrolizumab) | Baseline through CNS Progression or Death Up to 31 Months | CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline. Number of participants censored: TRT A = 112; TRT B = 59. | Months | MEDIAN |
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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