Trial · NCT03425643
Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)
NCT03425643, Phase 3, Active not recruiting, Merck Sharp & Dohme LLC; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671). Trials, record NCT03425643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03425643
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)
- NCT number
- NCT03425643
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 797 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Pembrolizumab, Placebo, Cisplatin, Gemcitabine, Pemetrexed
- First posted
- 2018-02-07
- Last updated
- 2026-07-29
- Other registries' IDs
- eudract:2017-001832-21
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event Free Survival (EFS) | Up to approximately 5 years | EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The EFS for all participants is presented (through database cut-off date of 10-Jul-2023). |
| Primary | Overall Survival (OS) | Up to approximately 5 years | OS is defined as the time from randomization until death from any cause. The OS for all participants is presented (through database cut-off date of 10-Jul-2023). |
| Secondary | Major Pathological Response (mPR) Rate | Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20) | mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. The mPR rates as assessed by blinded independent pathologist are presented. |
| Secondary | Pathological Complete Response (pCR) Rate | Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20) | pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. The pCR rates as assessed by blinded independent pathologist are presented. |
| Secondary | Change From Baseline in Neoadjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score | Baseline (cycle 1 in neoadjuvant phase) and neoadjuvant week 11 | Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL. |
| Secondary | Change From Baseline in Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score | Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30) | Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL. |
| Secondary | Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 71 weeks | |
| Secondary | Number of Participants Who Experience Perioperative Complications | Up to approximately 51 weeks following surgery | Perioperative complications are a discrete set of both intraoperative and postoperative complications, potentially contributing to increased length of inpatient care and/or delay of adjuvant therapy. The number of participants experiencing perioperative complications will be assessed. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Up to approximately 57 weeks |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event Free Survival (EFS) | Up to approximately 5 years | The analysis population consisted of all randomized participants. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to approximately 5 years | The analysis population consisted of all randomized participants. | Months | MEDIAN |
| SECONDARY | Major Pathological Response (mPR) Rate | Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20) | The analysis population consisted of all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Pathological Complete Response (pCR) Rate | Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20) | The analysis population consisted of all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Neoadjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score | Baseline (cycle 1 in neoadjuvant phase) and neoadjuvant week 11 | All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 30 assessment data available. | Sore on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score | Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30) | All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 30 assessment data available. | Sore on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 71 weeks | |||
| SECONDARY | Number of Participants Who Experience Perioperative Complications | Up to approximately 51 weeks following surgery | The analysis population consisted of all randomized participants who received at least one dose of neoadjuvant study treatment and also undergo on-study surgery. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Up to approximately 57 weeks |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event Free Survival (EFS) | NAC + Neoadjuvant/Adjuvant Pembrolizumab | 47.2 | 95% Confidence Interval 32.9 to NA | Months | |
| Event Free Survival (EFS) | NAC + Neoadjuvant/Adjuvant Placebo | 18.3 | 95% Confidence Interval 14.8 to 22.1 | Months | |
| Overall Survival (OS) | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | NAC + Neoadjuvant/Adjuvant Placebo | 52.4 | 95% Confidence Interval 45.7 to NA | Months | |
| Major Pathological Response (mPR) Rate | NAC + Neoadjuvant/Adjuvant Pembrolizumab | 30.2 | 95% Confidence Interval 25.7 to 35.0 | Percentage of Participants | |
| Major Pathological Response (mPR) Rate | NAC + Neoadjuvant/Adjuvant Placebo | 11.0 | 95% Confidence Interval 8.1 to 14.5 | Percentage of Participants | |
| Pathological Complete Response (pCR) Rate | NAC + Neoadjuvant/Adjuvant Pembrolizumab | 18.1 | 95% Confidence Interval 14.5 to 22.3 | Percentage of Participants | |
| Pathological Complete Response (pCR) Rate | NAC + Neoadjuvant/Adjuvant Placebo | 4.0 | 95% Confidence Interval 2.3 to 6.4 | Percentage of Participants | |
| Change From Baseline in Neoadjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score | NAC + Neoadjuvant/Adjuvant Pembrolizumab | -9.31 | 95% Confidence Interval -11.67 to -6.94 | Sore on a scale | |
| Change From Baseline in Neoadjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score | NAC + Neoadjuvant/Adjuvant Placebo | -10.73 | 95% Confidence Interval -13.07 to -8.40 | Sore on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NAC + Neoadjuvant/Adjuvant Pembrolizumab | 397 | |
| Overall Study | STARTED | NAC + Neoadjuvant/Adjuvant Placebo | 400 | |
| Overall Study | Treated | NAC + Neoadjuvant/Adjuvant Pembrolizumab | 396 | |
| Overall Study | Treated | NAC + Neoadjuvant/Adjuvant Placebo | 399 | |
| Overall Study | COMPLETED | NAC + Neoadjuvant/Adjuvant Pembrolizumab | 0 | |
| Overall Study | COMPLETED | NAC + Neoadjuvant/Adjuvant Placebo | 0 | |
| Overall Study | NOT COMPLETED | NAC + Neoadjuvant/Adjuvant Pembrolizumab | 397 | |
| Overall Study | NOT COMPLETED | NAC + Neoadjuvant/Adjuvant Placebo | 400 |
Source ClinicalTrials.gov
Adverse events524
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 | Pembro + Chemo/Pembro | 163 | 396 | 229 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Chemo/Placebo | 165 | 399 | 233 |
| other | Tinnitus | Ear and labyrinth disorders | Pembro + Chemo/Pembro | 29 | 396 | 31 |
| other | Tinnitus | Ear and labyrinth disorders | Placebo + Chemo/Placebo | 23 | 399 | 25 |
| other | Hypothyroidism | Endocrine disorders | Pembro + Chemo/Pembro | 42 | 396 | 46 |
| other | Hypothyroidism | Endocrine disorders | Placebo + Chemo/Placebo | 6 | 399 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Pembro + Chemo/Pembro | 22 | 396 | 22 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo + Chemo/Placebo | 18 | 399 | 19 |
| other | Constipation | Gastrointestinal disorders | Pembro + Chemo/Pembro | 154 | 396 | 207 |
| other | Constipation | Gastrointestinal disorders | Placebo + Chemo/Placebo | 146 | 399 | 205 |
1 to 10 of 524Source ClinicalTrials.gov
See all 524 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembro + Chemo/Pembro | 110 | 397 |
| Total, all-cause mortality | Placebo + Chemo/Placebo | 144 | 400 |
| Total, other adverse events | Pembro + Chemo/Pembro | 389 | 396 |
| Total, other adverse events | Placebo + Chemo/Placebo | 388 | 399 |
| Total, serious adverse events | Pembro + Chemo/Pembro | 165 | 396 |
| Total, serious adverse events | Placebo + Chemo/Placebo | 133 | 399 |
Source ClinicalTrials.gov
Papers7
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembro + Chemo/Pembro vs Placebo + Chemo/Placebo: deaths from any cause | Trial comparisons |
| NAC + Neoadjuvant/Adjuvant Pembrolizumab vs NAC + Neoadjuvant/Adjuvant Placebo: Number of Participants Who Experience Perioperative Complications | Trial comparisons |
| Pembro + Chemo/Pembro vs Placebo + Chemo/Placebo: 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/NCT03425643
GET https://conductscience.org/api/trials/v1/NCT03425643/events?page=2