Trial · NCT05224141
Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)
NCT05224141, Phase 3, Active not recruiting, Merck Sharp & Dohme LLC; results first posted 2025-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008). Trials, record NCT05224141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05224141
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)
- NCT number
- NCT05224141
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 460 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Small Cell Lung Carcinoma
- Interventions
- Pembrolizumab/Vibostolimab Co-Formulation, Saline placebo, Etoposide, Cisplatin, Atezolizumab, Carboplatin
- First posted
- 2022-02-04
- Last updated
- 2025-07-08
- Other registries' IDs
- eudract:2021-005034-42
- Results first posted
- 2025-05-30
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to approximately 25 months | Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data. |
| Secondary | Progression-Free Survival (PFS) | Up to approximately 25 months | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method; participants who did not experience a PFS event were censored at the last disease assessment, or the last assessment before new anticancer treatment if new treatment was initiated. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented. |
| Secondary | Objective Response Rate (ORR) | Up to approximately 25 months | ORR was defined as the percentage of participants in the analysis population who have a confirmed Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The ORR was calculated using the Miettinen \& Nurminen method stratified by baseline ECOG performance status (0 or 1), baseline LDH (≤ or \> upper limit of normal \[ULN\]), and baseline presence of liver metastasis (Yes or No), or brain metastasis (Yes or No). |
| Secondary | Duration of Response (DOR) | Up to approximately 25 months | For participants who demonstrated a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per RECIST 1.1, DOR was defined as the time from first documented CR or PR until progressive disease (PD) or death from any cause, whichever occurs first. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). DOR was calculated using the nonparametric Kaplan-Meier method for censored data. |
| Secondary | Percentage of Participants Who Experienced an Adverse Event (AE) | Up to approximately 60 months | An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Secondary | Percentage of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 60 months | An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Secondary | Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Baseline and up to approximately 60 months | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. |
| Secondary | Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | Baseline and up to approximately 60 months | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. |
| Secondary | Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | Baseline and up to approximately 60 months | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. |
| Secondary | Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) | Baseline and up to approximately 60 months | The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Up to approximately 25 months | Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Up to approximately 25 months | Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Up to approximately 25 months | Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to approximately 25 months | Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized and experienced a CR or PR. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Experienced an Adverse Event (AE) | Up to approximately 60 months | |||
| SECONDARY | Percentage of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 60 months | |||
| SECONDARY | Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Baseline and up to approximately 60 months | |||
| SECONDARY | Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | Baseline and up to approximately 60 months | |||
| SECONDARY | Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | Baseline and up to approximately 60 months | |||
| SECONDARY | Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) | Baseline and up to approximately 60 months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Pembrolizumab/Vibostolimab | 11.5 | 95% Confidence Interval 9.8 to 12.6 | Months | |
| Overall Survival (OS) | Atezolizumab | 12.9 | 95% Confidence Interval 11.6 to 14.8 | Months | |
| Progression-Free Survival (PFS) | Pembrolizumab/Vibostolimab | 5.3 | 95% Confidence Interval 4.4 to 5.4 | Months | |
| Progression-Free Survival (PFS) | Atezolizumab | 4.5 | 95% Confidence Interval 4.4 to 5.3 | Months | |
| Objective Response Rate (ORR) | Pembrolizumab/Vibostolimab | 71.7 | 95% Confidence Interval 65.4 to 77.5 | Percentage of Participants | |
| Objective Response Rate (ORR) | Atezolizumab | 74.8 | 95% Confidence Interval 68.7 to 80.3 | Percentage of Participants | |
| Duration of Response (DOR) | Pembrolizumab/Vibostolimab | 4.2 | 95% Confidence Interval 4.1 to 4.3 | Months | |
| Duration of Response (DOR) | Atezolizumab | 3.9 | 95% Confidence Interval 3.4 to 4.1 | Months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab/Vibostolimab | 230 | |
| Overall Study | STARTED | Atezolizumab | 230 | |
| Overall Study | Treated | Pembrolizumab/Vibostolimab | 229 | |
| Overall Study | Treated | Atezolizumab | 229 | |
| Overall Study | COMPLETED | Pembrolizumab/Vibostolimab | 0 | |
| Overall Study | COMPLETED | Atezolizumab | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab/Vibostolimab | 230 | |
| Overall Study | NOT COMPLETED | Atezolizumab | 230 |
Source ClinicalTrials.gov
Adverse events432
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 | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab/Vibostolimab | 154 | 229 | 228 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab | 130 | 229 | 181 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab/Vibostolimab | 95 | 229 | 259 |
| other | Leukopenia | Blood and lymphatic system disorders | Atezolizumab | 87 | 229 | 187 |
| other | Lymphopenia | Blood and lymphatic system disorders | Pembrolizumab/Vibostolimab | 25 | 229 | 50 |
| other | Lymphopenia | Blood and lymphatic system disorders | Atezolizumab | 14 | 229 | 28 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab/Vibostolimab | 130 | 229 | 320 |
| other | Neutropenia | Blood and lymphatic system disorders | Atezolizumab | 126 | 229 | 260 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pembrolizumab/Vibostolimab | 80 | 229 | 157 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Atezolizumab | 73 | 229 | 128 |
1 to 10 of 432Source ClinicalTrials.gov
See all 432 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab/Vibostolimab | 155 | 230 |
| Total, all-cause mortality | Atezolizumab | 141 | 230 |
| Total, other adverse events | Pembrolizumab/Vibostolimab | 228 | 229 |
| Total, other adverse events | Atezolizumab | 222 | 229 |
| Total, serious adverse events | Pembrolizumab/Vibostolimab | 120 | 229 |
| Total, serious adverse events | Atezolizumab | 96 | 229 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab/Vibostolimab vs Atezolizumab: deaths from any cause | Trial comparisons |
| Pembrolizumab/Vibostolimab vs Atezolizumab: serious adverse events | Trial comparisons |
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.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05224141
GET https://conductscience.org/api/trials/v1/NCT05224141/events?page=2