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Active, not recruitingNCT03425643Updated Jul 29, 2026Results posted

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)

A Phase 3 interventional study of Pembrolizumab and Placebo in Non-small Cell Lung Cancer, sponsored by Merck Sharp & Dohme LLC. Active, not recruiting at 227 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
797
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).

02

Conditions studied

  • Non-small Cell Lung Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC.
  • If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention.
  • If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
  • Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization.
  • Have adequate organ function.

Exclusion criteria

Exclusion Criteria:

  • Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor.
  • Has a history of (non-infectious) pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
  • Has an active infection requiring systemic therapy.
  • Has had an allogenic tissue/sold organ transplant.
  • Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients.
  • Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or to any of their excipients.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of Hepatitis B or Hepatitis C.
  • Has a known history of active tuberculosis.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor.
  • Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation.
  • Has received prior radiotherapy within 2 weeks of start of trial treatment.
  • Has received a live vaccine within 30 days prior to the first dose of trial drug.
  • Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
  • Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug.
  • Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
797 participants (actual)

Study arms

  • Experimental
    NAC + Neoadjuvant/Adjuvant Pembrolizumab

    Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\].

    Biological: Pembrolizumab · Drug: Cisplatin · Drug: Gemcitabine · Drug: Pemetrexed

  • Placebo comparator
    NAC + Neoadjuvant/Adjuvant Placebo

    Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\].

    Drug: Placebo · Drug: Cisplatin · Drug: Gemcitabine · Drug: Pemetrexed

Interventions

  • BiologicalPembrolizumab

    200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.

    Also known as: KEYTRUDA®, MK-3475

  • DrugPlacebo

    Normal saline by IV infusion Q3W, given on cycle day 1.

  • DrugCisplatin

    75 mg/m\^2 by IV infusion Q3W, given on cycle day 1.

    Also known as: PLATINOL®

  • DrugGemcitabine

    1000 mg/m\^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.

    Also known as: GEMZAR®

  • DrugPemetrexed

    500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.

    Also known as: Alimta®

05

What researchers measure

Primary outcomes

  1. Event Free Survival (EFS)

    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).

    Time frame: Up to approximately 5 years

  2. Overall Survival (OS)

    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).

    Time frame: Up to approximately 5 years

Secondary outcomes

  1. Major Pathological Response (mPR) Rate

    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.

    Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)

  2. Pathological Complete Response (pCR) Rate

    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.

    Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)

  3. 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

    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.

    Time frame: Baseline (cycle 1 in neoadjuvant phase) and neoadjuvant week 11

  4. 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

    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.

    Time frame: Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)

  5. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 71 weeks

  6. Number of Participants Who Experience Perioperative Complications

    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.

    Time frame: Up to approximately 51 weeks following surgery

  7. Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)

    Time frame: Up to approximately 57 weeks

06

Results

Posted Sep 19, 2024

Participant flow

Adult participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC) were recruited to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery \[neoadjuvant phase\], followed by pembrolizumab alone after surgery \[adjuvant phase\].

Participant flow — Overall Study
MilestoneNAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant Placebo
Started397400
Treated396399
Completed00
Not completed397400
Withdrew: Withdrawal by subject1012
Withdrew: Lost to follow-up20
Withdrew: Death109141
Withdrew: Ongoing in study276247

Outcome measures

PrimaryEvent Free Survival (EFS)

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).

Time frame:
Up to approximately 5 years
Reported as:
Median · Months
Event Free Survival (EFS)
MonthsNAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant Placebo
Event Free Survival (EFS)47.2 (32.9 to NA)18.3 (14.8 to 22.1)
Statistical analysis
  • NAC + Neoadjuvant/Adjuvant Pembrolizumab vs NAC + Neoadjuvant/Adjuvant Placebo · Log Rank · p = <0.00001 (One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).) · Hazard ratio (hr): 0.59 · 95% CI 0.48 to 0.72Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).
PrimaryOverall Survival (OS)

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).

Time frame:
Up to approximately 5 years
Reported as:
Median · Months
Overall Survival (OS)
MonthsNAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant Placebo
Overall Survival (OS)NA (NA to NA)52.4 (45.7 to NA)
Statistical analysis
  • NAC + Neoadjuvant/Adjuvant Pembrolizumab vs NAC + Neoadjuvant/Adjuvant Placebo · Log Rank · p = 0.00517 (One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).) · Hazard ratio (hr): 0.72 · 95% CI 0.56 to 0.93Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).
SecondaryMajor Pathological Response (mPR) Rate

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.

Time frame:
Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
Reported as:
Number · Percentage of Participants
Major Pathological Response (mPR) Rate
Percentage of ParticipantsNAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant Placebo
Major Pathological Response (mPR) Rate30.2 (25.7 to 35.0)11.0 (8.1 to 14.5)
Statistical analysis
  • NAC + Neoadjuvant/Adjuvant Pembrolizumab vs NAC + Neoadjuvant/Adjuvant Placebo · Stratified Miettinen and Nurminen · p = <0.00001 · Difference in percentage: 19.2 · 95% CI 13.9 to 24.7
SecondaryPathological Complete Response (pCR) Rate

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.

Time frame:
Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
Reported as:
Number · Percentage of Participants
Pathological Complete Response (pCR) Rate
Percentage of ParticipantsNAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant Placebo
Pathological Complete Response (pCR) Rate18.1 (14.5 to 22.3)4.0 (2.3 to 6.4)
Statistical analysis
  • NAC + Neoadjuvant/Adjuvant Pembrolizumab vs NAC + Neoadjuvant/Adjuvant Placebo · Stratified Miettinen and Nurminen · p = <0.00001 · Difference in pertentage: 14.2 · 95% CI 10.1 to 18.7
SecondaryChange 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

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.

Time frame:
Baseline (cycle 1 in neoadjuvant phase) and neoadjuvant week 11
Reported as:
Least squares mean · 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
Sore on a scaleNAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant Placebo
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-9.31 (-11.67 to -6.94)-10.73 (-13.07 to -8.40)
Statistical analysis
  • NAC + Neoadjuvant/Adjuvant Pembrolizumab vs NAC + Neoadjuvant/Adjuvant Placebo · t-test, 2 sided · p = 0.3611 · Difference in least square means: 1.43 · 95% CI -1.64 to 4.49
SecondaryChange 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

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.

Time frame:
Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)
Reported as:
Least squares mean · Sore on a scale
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
Sore on a scaleNAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant Placebo
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-1.52 (-3.67 to 0.63)-3.74 (-5.96 to -1.52)
Statistical analysis
  • NAC + Neoadjuvant/Adjuvant Pembrolizumab vs NAC + Neoadjuvant/Adjuvant Placebo · t-test, 2 sided · p = 0.1197 · Difference in least square means: 2.22 · 95% CI -0.58 to 5.02
SecondaryNumber of Participants Who Experience an Adverse Event (AE)
Time frame:
Up to approximately 71 weeks

Results for this outcome have not been posted.

SecondaryNumber of Participants Who Experience Perioperative Complications

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.

Time frame:
Up to approximately 51 weeks following surgery
Reported as:
Count of participants · Participants
Number of Participants Who Experience Perioperative Complications
ParticipantsNAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant Placebo
Number of Participants Who Experience Perioperative Complications233229
SecondaryNumber of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Time frame:
Up to approximately 57 weeks

Results for this outcome have not been posted.

Adverse events

Collected over Up to approximately 71 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pembro + Chemo/Pembro110/397 (27.7%)165/396 (41.7%)389/396 (98.2%)
Placebo + Chemo/Placebo144/400 (36%)133/399 (33.3%)388/399 (97.2%)
Most frequent serious events
Showing 10 of 208
Most frequent serious events
EventPembro + Chemo/PembroPlacebo + Chemo/Placebo
PneumoniaInfections and infestations21/39619/399
Platelet count decreasedInvestigations3/39610/399
Pulmonary embolismRespiratory, thoracic and mediastinal disorders9/3969/399
AnaemiaBlood and lymphatic system disorders8/3963/399
PyrexiaGeneral disorders8/3961/399
Aspartate aminotransferase increasedInvestigations7/3961/399
Pleural effusionRespiratory, thoracic and mediastinal disorders3/3967/399
Neutrophil count decreasedInvestigations6/3961/399
PneumothoraxRespiratory, thoracic and mediastinal disorders6/3964/399
Atrial fibrillationCardiac disorders5/3963/399
Most frequent other events
Showing 10 of 54
Most frequent other events
EventPembro + Chemo/PembroPlacebo + Chemo/Placebo
NauseaGastrointestinal disorders228/396210/399
Neutrophil count decreasedInvestigations171/396169/399
AnaemiaBlood and lymphatic system disorders163/396165/399
ConstipationGastrointestinal disorders154/396146/399
FatigueGeneral disorders125/396101/399
Decreased appetiteMetabolism and nutrition disorders115/396102/399
White blood cell count decreasedInvestigations112/396102/399
VomitingGastrointestinal disorders81/39668/399
DiarrhoeaGastrointestinal disorders78/39673/399
Platelet count decreasedInvestigations74/39673/399

Baseline characteristics

Age, Continuous
Age, Continuous(Years)NAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant PlaceboTotal
Mean62.7 ± 8.563.6 ± 8.163.1 ± 8.3
Sex: Female, Male
Sex: Female, Male(Participants)NAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant PlaceboTotal
Female118116234
Male279284563
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant PlaceboTotal
Hispanic or Latino363470
Not Hispanic or Latino329333662
Unknown or Not Reported323365
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant PlaceboTotal
American Indian or Alaska Native101
Asian124125249
Native Hawaiian or Other Pacific Islander000
Black or African American61016
White250239489
More than one race31013
Unknown or Not Reported131629
Histology
Histology(Participants)NAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant PlaceboTotal
Squamous171173344
Non-Squamous226227453
Overall Cancer Staging
Overall Cancer Staging(Participants)NAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant PlaceboTotal
Stage II118121239
Stage III279279558
PD-L1 Expression Level (50% cutoff)
PD-L1 Expression Level (50% cutoff)(Participants)NAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant PlaceboTotal
TPS>=50%132134266
TPS<50%265266531
Region
Region(Participants)NAC + Neoadjuvant/Adjuvant PembrolizumabNAC + Neoadjuvant/Adjuvant PlaceboTotal
East-Asia123121244
Non-East Asia274279553
07

Study locations

227 sites
  • Banner MD Anderson Cancer Center ( Site 0028)
    Gilbert, Arizona 85234, United States
  • Western Regional Medical Center, Inc. ( Site 0050)
    Goodyear, Arizona 85338, United States
  • University of Arizona Cancer Center - Dignity Health ( Site 0062)
    Phoenix, Arizona 85004, United States
  • University of Arizona Cancer Center ( Site 0012)
    Tucson, Arizona 85724, United States
  • Pacific Cancer Medical Center, Inc. ( Site 0004)
    Anaheim, California 92801, United States
  • Providence Saint Joseph Medical Center ( Site 0061)
    Burbank, California 91505, United States
  • Pacific Cancer Care ( Site 0035)
    Monterey, California 93940, United States
  • John Wayne Cancer Institute ( Site 0049)
    Santa Monica, California 90404, United States
  • St Joseph Heritage Healthcare ( Site 0040)
    Santa Rosa, California 95403, United States
  • Stanford University, Stanford Cancer Center ( Site 0046)
    Stanford, California 94305, United States
  • Hartford Hospital ( Site 0069)
    Hartford, Connecticut 06102, United States
  • Helen F. Graham Cancer Center & Research Institute ( Site 0015)
    Newark, Delaware 19718, United States
  • Mayo Clinic Jacksonville ( Site 0022)
    Jacksonville, Florida 32224, United States
  • Miami Cancer Institute-Baptist Hospital ( Site 0068)
    Miami, Florida 33176, United States
  • Southeastern Regional Medical Center ( Site 0051)
    Newnan, Georgia 30265, United States
  • Northwest Oncology and Hematology ( Site 0001)
    Elk Grove Village, Illinois 60007, United States
  • Ingalls Memorial Hospital ( Site 0044)
    Harvey, Illinois 60426, United States
  • PPG-Oncology ( Site 0043)
    Fort Wayne, Indiana 46845, United States
  • University of Iowa Hospital and Clinics ( Site 0010)
    Iowa City, Iowa 52242, United States
  • Ashland-Bellefonte Cancer Center ( Site 0021)
    Ashland, Kentucky 41101, United States
  • Harry & Jeanette Weinberg Cancer Institute ( Site 0081)
    Baltimore, Maryland 21237, United States
  • Boston Medical Center ( Site 0057)
    Boston, Massachusetts 02118, United States
  • UMass Memorial Medical Center ( Site 0030)
    Worcester, Massachusetts 01655, United States
  • Henry Ford Health System ( Site 0031)
    Detroit, Michigan 48202, United States
  • Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)
    Lansing, Michigan 48912, United States
  • Mayo Clinic ( Site 0026)
    Rochester, Minnesota 55905, United States
  • St. Vincent Healthcare Frontier Cancer Center ( Site 0005)
    Billings, Montana 59102, United States
  • University of Nebraska Medical Center ( Site 0047)
    Omaha, Nebraska 68198-7680, United States
  • Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)
    Basking Ridge, New Jersey 07920, United States
  • Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)
    Middletown, New Jersey 07748, United States
  • MSKCC-Bergen ( Site 0075)
    Montvale, New Jersey 07645, United States
  • St. Peter's Hospital Cancer Care Center ( Site 0039)
    Albany, New York 12208, United States
  • Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076)
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)
    Harrison, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center ( Site 0060)
    New York, New York 10065, United States
  • Stony Brook University Medical Center - Cancer Center ( Site 0019)
    Stony Brook, New York 11794-9447, United States
  • Montefiore Einstein Center ( Site 0016)
    The Bronx, New York 10461, United States
  • Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)
    Uniondale, New York 11553, United States
  • White Plains Hospital Center for Cancer Care ( Site 0007)
    White Plains, New York 10601, United States
  • Southwestern Regional Medical Center, Inc. ( Site 0054)
    Tulsa, Oklahoma 74133, United States
  • OHSU Center for Health & Healing ( Site 1006)
    Portland, Oregon 97239, United States
  • UPMC Pinnacle Health System - East Location ( Site 0063)
    Harrisburg, Pennsylvania 17109, United States
  • Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053)
    Philadelphia, Pennsylvania 19124, United States
  • Allegheny General Hospital ( Site 0009)
    Pittsburgh, Pennsylvania 15212, United States
  • UPMC Hillman Cancer Centers ( Site 0041)
    Pittsburgh, Pennsylvania 15232, United States
  • VA Pittsburgh Healthcare System ( Site 0052)
    Pittsburgh, Pennsylvania 15240, United States
  • Saint Francis Cancer Center ( Site 0096)
    Greenville, South Carolina 29607, United States
  • Emily Couric Clinical Cancer Center ( Site 0013)
    Charlottesville, Virginia 22903, United States
  • Inova Schar Cancer Institute ( Site 0032)
    Fairfax, Virginia 22031, United States
  • Virginia Cancer Specialists, PC ( Site 0080)
    Fairfax, Virginia 22031, United States
  • Providence Regional Cancer Partnership ( Site 0065)
    Everett, Washington 98201, United States
  • Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)
    Berazategui, Buenos Aires B1884BBF, Argentina
  • Hospital Privado de Comunidad. ( Site 0130)
    Mar del Plata, Buenos Aires B7602CBM, Argentina
  • Hospital Universitario Austral ( Site 0127)
    Pilar, Buenos Aires B1629ODT, Argentina
  • Fundacion Favaloro ( Site 0128)
    Ciudad de Buenos Aires, Buenos Aires F.D. C1093AAS, Argentina
  • Sanatorio Britanico ( Site 0125)
    Rosario, Santa Fe Province S2000CVB, Argentina
  • Sanatorio Parque ( Site 0135)
    Rosario, Santa Fe Province S2000DSV, Argentina
  • Hospital Provincial del Centenario ( Site 0131)
    Rosario, Santa Fe Province S2002KDS, Argentina
  • Hospital Privado Universitario de Córdoba ( Site 0139)
    Córdoba, 5016, Argentina
  • Sanatorio Allende ( Site 0129)
    Córdoba, X5000JHQ, Argentina
  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133)
    San Juan, J5402DIL, Argentina
  • Orange Health Services ( Site 0624)
    Orange, New South Wales 2800, Australia
  • Westmead Hospital ( Site 0621)
    Westmead, New South Wales 2145, Australia
  • AZ Sint-Maarten ( Site 0226)
    Mechelen, Antwerpen 2800, Belgium
  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223)
    Liège, Liege 4000, Belgium
  • UZ Gent ( Site 0224)
    Ghent, Oost-Vlaanderen 9000, Belgium
  • AZ Nikolaas ( Site 0225)
    Sint-Niklaas, Oost-Vlaanderen 9100, Belgium
  • UZ Leuven ( Site 0221)
    Leuven, Vlaams-Brabant 3000, Belgium
  • AZ Delta ( Site 0222)
    Roeselare, West-Vlaanderen 8800, Belgium
  • Centro Regional Integrado de Oncologia ( Site 0160)
    Fortaleza, Ceará 60336-232, Brazil
  • Instituto do Cancer do Ceara ( Site 0152)
    Fortaleza, Ceará 60430-230, Brazil
  • Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159)
    Brasília, Federal District 70200-730, Brazil
  • Liga Norte Riograndense Contra o Cancer ( Site 0150)
    Natal, Rio Grande do Norte 59075-740, Brazil
  • Hospital de Caridade de Ijui ( Site 0153)
    Ijuí, Rio Grande do Sul 98700 000, Brazil
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146)
    Porto Alegre, Rio Grande do Sul 90610-000, Brazil
  • Hospital Nossa Senhora da Conceicao ( Site 0145)
    Porto Alegre, Rio Grande do Sul 91350-200, Brazil
  • YNOVA Pesquisa Clinica ( Site 0823)
    Florianópolis, Santa Catarina 88020-210, Brazil
  • Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144)
    Barretos, São Paulo 14784-400, Brazil
  • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)
    Rio de Janeiro, 20230-130, Brazil
  • Hospital Paulistano - Amil Clinical Research ( Site 0822)
    São Paulo, 01321-001, Brazil
  • Hospital Alemao Oswaldo Cruz ( Site 0158)
    São Paulo, 01327-001, Brazil
  • Princess Margaret Cancer Centre ( Site 0109)
    Toronto, Ontario M5G 2M9, Canada
  • CIUSSS du Saguenay-Lac-St-Jean ( Site 0101)
    Chicoutimi, Quebec G7H 5H6, Canada
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110)
    Montreal, Quebec H2X 0C1, Canada
  • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104)
    Montreal, Quebec H3T 1M5, Canada
  • McGill University Health Centre ( Site 0111)
    Montreal, Quebec H4A 3J1, Canada
  • Tianjin Medical University General Hospital ( Site 0806)
    Tianjin, Anhui 300052, China
  • Beijing Cancer Hospital ( Site 0810)
    Beijing, Beijing Municipality 100010, China
  • Beijing Cancer Hospital ( Site 0811)
    Beijing, Beijing Municipality 100010, China
  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801)
    Beijing, Beijing Municipality 100021, China
  • Peking University Third Hospital ( Site 0812)
    Beijing, Beijing Municipality 100191, China
  • Peking Union Medical College Hospital ( Site 0809)
    Beijing, Beijing Municipality 100730, China
  • Sun Yat-Sen University Cancer Center ( Site 0816)
    Guangzhou, Guangdong 510060, China
  • Hunan Cancer Hospital ( Site 0815)
    Changsha, Hunan 410013, China
  • Fudan University Shanghai Cancer Center ( Site 0813)
    Shanghai, Shanghai Municipality 200032, China
  • Zhongshan Hospital of Fudan University ( Site 0808)
    Shanghai, Shanghai Municipality 200032, China
  • Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817)
    Shanghai, Shanghai Municipality 200433, China
  • Tang Du Hospital ( Site 0803)
    Xi’an, Shanxi 710038, China
  • The First Affiliated Hospital of Zhejiang University ( Site 0804)
    Hangzhou, Zhejiang 310003, China
  • Zhejiang Cancer Hospital.... ( Site 0814)
    Hangzhou, Zhejiang 310022, China

Showing the first 100 of 227 sites across 25 countries.

08

References and documents

Publications

  • Spicer JD, Garassino MC, Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Arunachalam A, Keller SM, Samkari A, Gao S; KEYNOTE-671 Investigators. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Sep 28;404(10459):1240-1252. doi: 10.1016/S0140-6736(24)01756-2. Epub 2024 Sep 14. PubMed 39288781 ↗
  • Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Gao S, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Keller SM, Samkari A, Spicer JD; KEYNOTE-671 Investigators. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):491-503. doi: 10.1056/NEJMoa2302983. Epub 2023 Jun 3. PubMed 37272513 ↗
  • Tsuboi M, Wakelee H, Garassino MC, Gao S, Luft A, Chen KN, Spicer JD, Zhu Y, Saji H, Okada M, Vanakesa T, Chen H, Zhao G, Ikeda N, Jones DR, Weksler B, Huang CS, Jensen E, Keller SM, Samkari A, Liberman M. A Subgroup Analysis of Perioperative Pembrolizumab in Clinical Stage II Non-Small-Cell Lung Cancer from the Randomized KEYNOTE-671 Study. Eur J Cardiothorac Surg. 2026 Mar 10;68(3):ezag028. doi: 10.1093/ejcts/ezag028. PubMed 41875364 ↗
  • Aredo JV, Wakelee HA. Top advances of the year: Perioperative therapy for lung cancer. Cancer. 2024 Sep 1;130(17):2897-2903. doi: 10.1002/cncr.35357. Epub 2024 May 8. PubMed 38717993 ↗
  • Romero Roman A, Campo-Canaveral de la Cruz JL, Macia I, Escobar Campuzano I, Figueroa Almanzar S, Delgado Roel M, Galvez Munoz C, Garcia Fontan EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martinez Tellez E, Partida Gonzalez C, Jimenez Lopez MF, Jimenez Maestre U, Mongil Poce R, Sanchez Lorente D, Alvarez Kindelan A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007. PubMed 33661301 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 29, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

09

Registry details

Key details

Study ID
NCT03425643
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Feb 7, 2018
Start date
Apr 24, 2018
Primary completion
Jul 10, 2023
Completion
Oct 15, 2026 (estimated)
Results posted
Sep 19, 2024
Last update
Jul 29, 2026

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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