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 (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
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Among 127 studies testing pembrolizumab in Carcinoma, Non-Small-Cell Lung — 29 open to participants now, 48 under way, 13 of them phase 3. pembrolizumab · Carcinoma, Non-Small-Cell Lung.
Among the 127 studies testing pembrolizumab in Carcinoma, Non-Small-Cell Lung, this one is the 10th largest by enrollment, is one of 15 that started in 2018, is one of 28 in phase 3, reaches primary completion later than 3 of the 47 other live ones, and was the 48th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →29 of the 127 studies testing pembrolizumab in Carcinoma, Non-Small-Cell Lung are open now, in 10 countries. Recruiting first, the newest first:
University of Chicago · Sites in United States
Ages 18+
EuroCityClinic LLC · Sites in Russia
Ages 18+
AHS Cancer Control Alberta · Sites in Canada
Ages 18+
UNICANCER · Sites in France
Ages 18+
Hunan Province Tumor Hospital · Sites in China
Ages 18–75
By country, each count listing its studies:
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, pembrolizumab is the treatment under test here. Read study by study →
127 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 29 · Phase 2 74 · Phase 3 30 · Phase 4 1
First in 2013; this study’s year is marked. 15 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 797 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 65 across the 127 interventional studies. Of the 67 that completed or were terminated, 56 (84%) have results posted.
This tab as a report to print or save as PDF → With an account.
39 of 127 have an industry lead sponsor. The 10 most frequent:
This study is registered under Merck Sharp & Dohme LLC, one of the names counted as Merck & Co., Inc. Under that name alone:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc: 14 open now, 26 under way, 18 of them phase 3. Of 65 finished, 49 (75%) have results posted.
Among the 91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc, this one is the 9th largest by enrollment of the 88 interventional ones that give a count, is one of 6 that started in 2018, is one of 38 in phase 3, reaches primary completion later than 0 of the 25 other live ones, and was the 43rd registered.
Merck & Co., Inc’s Carcinoma, Non-Small-Cell Lung studies by the year they started, since 2000.
13 of the studies testing pembrolizumab in Carcinoma, Non-Small-Cell Lung that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07162883Phase 3Qilu Pharmaceutical Co., Ltd.Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC) | 2026-12-31 |
| NCT04380636Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) | 2027-05-05 |
| NCT05085028Phase 3Imperial College LondonA Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) | 2027-05-31 |
| NCT05493566Emory UniversityLow-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer | 2027-01-07 |
| NCT06388031Peking Union Medical College HospitalICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI | 2027-01-10 |
Add all 13 to your calendar (.ics) → With an account.
Among the 127 studies testing pembrolizumab in Carcinoma, Non-Small-Cell Lung, from their registry updates:
Among Merck & Co., Inc’s 91 in Carcinoma, Non-Small-Cell Lung:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.
Also known as: KEYTRUDA®, MK-3475
Normal saline by IV infusion Q3W, given on cycle day 1.
75 mg/m\^2 by IV infusion Q3W, given on cycle day 1.
Also known as: PLATINOL®
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®
500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.
Also known as: Alimta®
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
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
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)
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)
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
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)
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 71 weeks
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
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Time frame: Up to approximately 57 weeks
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 \[adjuvant phase\].
| Milestone | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo |
|---|---|---|
| Started | 397 | 400 |
| Treated | 396 | 399 |
| Completed | 0 | 0 |
| Not completed | 397 | 400 |
| Withdrew: Withdrawal by subject | 10 | 12 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Death | 109 | 141 |
| Withdrew: Ongoing in study | 276 | 247 |
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).
| Months | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo |
|---|---|---|
| Event Free Survival (EFS) | 47.2 (32.9 to NA) | 18.3 (14.8 to 22.1) |
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).
| Months | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo |
|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | 52.4 (45.7 to NA) |
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.
| Percentage of Participants | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo |
|---|---|---|
| Major Pathological Response (mPR) Rate | 30.2 (25.7 to 35.0) | 11.0 (8.1 to 14.5) |
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.
| Percentage of Participants | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo |
|---|---|---|
| Pathological Complete Response (pCR) Rate | 18.1 (14.5 to 22.3) | 4.0 (2.3 to 6.4) |
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.
| Sore on a scale | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + 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) |
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.
| Sore on a scale | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + 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) |
Results for this outcome have not been posted.
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.
| Participants | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo |
|---|---|---|
| Number of Participants Who Experience Perioperative Complications | 233 | 229 |
Results for this outcome have not been posted.
Collected over Up to approximately 71 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembro + Chemo/Pembro | 110/397 (27.7%) | 165/396 (41.7%) | 389/396 (98.2%) |
| Placebo + Chemo/Placebo | 144/400 (36%) | 133/399 (33.3%) | 388/399 (97.2%) |
| Event | Pembro + Chemo/Pembro | Placebo + Chemo/Placebo |
|---|---|---|
| PneumoniaInfections and infestations | 21/396 | 19/399 |
| Platelet count decreasedInvestigations | 3/396 | 10/399 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 9/396 | 9/399 |
| AnaemiaBlood and lymphatic system disorders | 8/396 | 3/399 |
| PyrexiaGeneral disorders | 8/396 | 1/399 |
| Aspartate aminotransferase increasedInvestigations | 7/396 | 1/399 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 3/396 | 7/399 |
| Neutrophil count decreasedInvestigations | 6/396 | 1/399 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 6/396 | 4/399 |
| Atrial fibrillationCardiac disorders | 5/396 | 3/399 |
| Event | Pembro + Chemo/Pembro | Placebo + Chemo/Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 228/396 | 210/399 |
| Neutrophil count decreasedInvestigations | 171/396 | 169/399 |
| AnaemiaBlood and lymphatic system disorders | 163/396 | 165/399 |
| ConstipationGastrointestinal disorders | 154/396 | 146/399 |
| FatigueGeneral disorders | 125/396 | 101/399 |
| Decreased appetiteMetabolism and nutrition disorders | 115/396 | 102/399 |
| White blood cell count decreasedInvestigations | 112/396 | 102/399 |
| VomitingGastrointestinal disorders | 81/396 | 68/399 |
| DiarrhoeaGastrointestinal disorders | 78/396 | 73/399 |
| Platelet count decreasedInvestigations | 74/396 | 73/399 |
| Age, Continuous(Years) | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo | Total |
|---|---|---|---|
| Mean | 62.7 ± 8.5 | 63.6 ± 8.1 | 63.1 ± 8.3 |
| Sex: Female, Male(Participants) | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo | Total |
|---|---|---|---|
| Female | 118 | 116 | 234 |
| Male | 279 | 284 | 563 |
| Ethnicity (NIH/OMB)(Participants) | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 36 | 34 | 70 |
| Not Hispanic or Latino | 329 | 333 | 662 |
| Unknown or Not Reported | 32 | 33 | 65 |
| Race (NIH/OMB)(Participants) | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 124 | 125 | 249 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 10 | 16 |
| White | 250 | 239 | 489 |
| More than one race | 3 | 10 | 13 |
| Unknown or Not Reported | 13 | 16 | 29 |
| Histology(Participants) | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo | Total |
|---|---|---|---|
| Squamous | 171 | 173 | 344 |
| Non-Squamous | 226 | 227 | 453 |
| Overall Cancer Staging(Participants) | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo | Total |
|---|---|---|---|
| Stage II | 118 | 121 | 239 |
| Stage III | 279 | 279 | 558 |
| PD-L1 Expression Level (50% cutoff)(Participants) | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo | Total |
|---|---|---|---|
| TPS>=50% | 132 | 134 | 266 |
| TPS<50% | 265 | 266 | 531 |
| Region(Participants) | NAC + Neoadjuvant/Adjuvant Pembrolizumab | NAC + Neoadjuvant/Adjuvant Placebo | Total |
|---|---|---|---|
| East-Asia | 123 | 121 | 244 |
| Non-East Asia | 274 | 279 | 553 |
Showing the first 100 of 227 sites across 25 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Ran from Apr 2018 to primary completion in Jul 2023, 62 months.
Results were first posted in Sep 2024, 1 year 2 months after primary completion.
Of 315 industry-sponsored phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 57. This study's 62 months is above that.
Counting every sponsor, half of 424 studies reached it within 45 months; a quarter within 30 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Pembrolizumab
Carcinoma, Non-Small-Cell Lung →