A Phase 1 interventional study of Pembrolizumab and Trametinib in KRAS Gene Mutation, Metastatic Non-Squamous Non-Small Cell Lung Carcinoma and Recurrent Non-Squamous Non-Small Cell Lung Carcinoma, sponsored by Jonathan Riess. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Jonathan Riess · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 111th largest by enrollment, is one of 15 that started in 2018, is one of 22 in phase 1, and was the 44th 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 15 is below 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:
Jonathan Riess is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Jonathan Riess has 3 studies filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
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:
This tab as a report to print or save as PDF → With an account.
This phase Ib trial studies the side effects of pembrolizumab and trametinib in treating patients with non-small cell lung cancer and KRAS gene mutations that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and trametinib may work better in treating patients with non-small cell lung cancer.
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of pembrolizumab (MK-3475) when given in combination with trametinib in the proposed sequencing schemes in patients with advanced or metastatic non-small cell lung cancer with KRAS mutations.
SECONDARY OBJECTIVES:
To assess in a preliminary manner the clinical efficacy of these combinations with the proposed sequencing schemes including overall response rate and progression free survival.
TERTIARY OBJECTIVES:
To determine in an exploratory manner changes in PD-L1 expression as well as other immune correlates induced by mitogen-activated extracellular signal-regulated kinase (MEK) inhibition.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
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.
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.
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.
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.
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.
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.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
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.
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
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.
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.
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.
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.
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.
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.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
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.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
Patients receive trametinib PO daily. Beginning on day 1 of course 2, patients also receive pembrolizumab IV over 30 minutes. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Biological: Pembrolizumab · Drug: Trametinib
Patients receive pembrolizumab IV over 30 minutes on day 1. Beginning on day 1 of course 2, patients also receive trametinib PO daily. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Biological: Pembrolizumab · Drug: Trametinib
Given IV
Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
Given PO
Also known as: GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Mekinist
Incidence of Dose-limiting Toxicity (DLT) of Pembrolizumab and Trametinib Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 4.0
The occurrence of toxicities during the first two cycles (i.e. after completion of the lead in cycle and the first cycle where both pembrolizumab and trametinib are administered) will be considered a DLT, if judged by the Investigator to be possibly, probably or definitely related to study drug administration. Adverse events will be summarized descriptively by type and by severity, with number and relative frequency calculated for all non-zero occurrences.
Time frame: Up to 6 weeks
Overall Response Rate (ORR)
Association with response rate will be summarized descriptively by presenting the mean, standard deviation (SD), and other characteristics of molecular and immune measures, stratified by response status. Will assess whether one arm has superior ORR, using logistic regression analysis to control for clinical covariates.
Time frame: Up to 3 years
Progression-free Survival (PFS)
Associations of molecular and immune measures with PFS will be summarized descriptively by stratified Kaplan-Meier curves and, if numbers permit, by proportional hazards models with molecular and immune responses as predictors. Will assess whether one arm has superior PFS, using proportional hazards models to control for clinical covariates.
Time frame: Up to 3 years
| Milestone | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 |
|---|---|---|---|---|
| Started | 3 | 6 | 3 | 3 |
| Completed | 3 | 6 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 |
The occurrence of toxicities during the first two cycles (i.e. after completion of the lead in cycle and the first cycle where both pembrolizumab and trametinib are administered) will be considered a DLT, if judged by the Investigator to be possibly, probably or definitely related to study drug administration. Adverse events will be summarized descriptively by type and by severity, with number and relative frequency calculated for all non-zero occurrences.
| DLT | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 |
|---|---|---|---|---|
| Incidence of Dose-limiting Toxicity (DLT) of Pembrolizumab and Trametinib Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 4.0 | 0 | 1 | 0 | 0 |
Association with response rate will be summarized descriptively by presenting the mean, standard deviation (SD), and other characteristics of molecular and immune measures, stratified by response status. Will assess whether one arm has superior ORR, using logistic regression analysis to control for clinical covariates.
| percentage of participants | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 |
|---|---|---|---|---|
| Overall Response Rate (ORR) | 6 | 0 | 0 | 6 |
Associations of molecular and immune measures with PFS will be summarized descriptively by stratified Kaplan-Meier curves and, if numbers permit, by proportional hazards models with molecular and immune responses as predictors. Will assess whether one arm has superior PFS, using proportional hazards models to control for clinical covariates.
| months | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 |
|---|---|---|---|---|
| Progression-free Survival (PFS) | 4.79 (1.80 to 8.07) | 0 (0 to 0) | 2.08 (1.97 to 2.08) | 0 (0 to 0) |
Collected over Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Escalation Arm A Level 1 | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Escalation Arm A Level 2 | 0/6 (0%) | 1/6 (16.7%) | 6/6 (100%) |
| Escalation Arm B Level 1 | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Escalation Arm B Level 2 | 1/3 (33.3%) | 2/3 (66.7%) | 3/3 (100%) |
| Event | Escalation Arm A Level 1 | Escalation Arm A Level 2 | Escalation Arm B Level 1 | Escalation Arm B Level 2 |
|---|---|---|---|---|
| Lung infectionInfections and infestations | 1/3 | 0/6 | 0/3 | 0/3 |
| Retinal detachmentEye disorders | 1/3 | 0/6 | 0/3 | 0/3 |
| DiverticulitisGastrointestinal disorders | 1/3 | 0/6 | 0/3 | 0/3 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/3 | 0/6 | 0/3 | 1/3 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 0/3 | 0/6 | 0/3 | 1/3 |
| Thromboembolic eventVascular disorders | 0/3 | 0/6 | 0/3 | 1/3 |
| EsophagitisGastrointestinal disorders | 0/3 | 1/6 | 0/3 | 0/3 |
| Event | Escalation Arm A Level 1 | Escalation Arm A Level 2 | Escalation Arm B Level 1 | Escalation Arm B Level 2 |
|---|---|---|---|---|
| DiarrheaGastrointestinal disorders | 2/3 | 5/6 | 1/3 | 2/3 |
| AnorexiaMetabolism and nutrition disorders | 2/3 | 1/6 | 0/3 | 0/3 |
| CPK increasedInvestigations | 2/3 | 1/6 | 0/3 | 0/3 |
| FatigueGeneral disorders | 2/3 | 3/6 | 0/3 | 2/3 |
| HyponatremiaMetabolism and nutrition disorders | 2/3 | 1/6 | 0/3 | 0/3 |
| NauseaGastrointestinal disorders | 1/3 | 3/6 | 2/3 | 1/3 |
| PruritusSkin and subcutaneous tissue disorders | 1/3 | 1/6 | 1/3 | 2/3 |
| Rash acneiformSkin and subcutaneous tissue disorders | 2/3 | 1/6 | 2/3 | 1/3 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 2/3 | 4/6 | 0/3 | 2/3 |
| Aspartate aminotransferase increasedInvestigations | 0/3 | 3/6 | 1/3 | 0/3 |
15 participants with advanced NSCLC
| Age, Categorical(Participants) | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 4 | 2 | 0 | 9 |
| >=65 years | 0 | 2 | 1 | 3 | 6 |
| Sex: Female, Male(Participants) | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 | Total |
|---|---|---|---|---|---|
| Female | 2 | 4 | 1 | 2 | 9 |
| Male | 1 | 2 | 2 | 1 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 3 | 3 | 3 | 2 | 11 |
| Unknown or Not Reported | 0 | 2 | 0 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 0 | 1 |
| White | 2 | 3 | 2 | 3 | 10 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 0 | 0 | 2 |
| Region of Enrollment(participants) | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 | Total |
|---|---|---|---|---|---|
| United States | 3 | 6 | 3 | 3 | 15 |
| Mutation Status(Participants) | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 | Total |
|---|---|---|---|---|---|
| KRAS G12C | 1 | 0 | 1 | 1 | 3 |
| KRAS non-G12C | 1 | 6 | 2 | 1 | 10 |
| BRAF non-V600E | 0 | 0 | 0 | 1 | 1 |
| RAS Wild Type | 1 | 0 | 0 | 0 | 1 |
| Smoking Status(Participants) | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 | Total |
|---|---|---|---|---|---|
| Current | 0 | 0 | 0 | 1 | 1 |
| Former | 3 | 3 | 2 | 2 | 10 |
| Never | 0 | 3 | 1 | 0 | 4 |
| Prior PD1/PDL1 Treatment(Participants) | Escalation Arm A Dose Level 1 | Escalation Arm A Dose Level 2 | Escalation Arm B Dose Level 1 | Escalation Arm B Dose Level 2 | Total |
|---|---|---|---|---|---|
| Yes | 2 | 1 | 2 | 1 | 6 |
| No | 1 | 5 | 1 | 2 | 9 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2018 to primary completion in Jan 2021, 31 months.
Results were first posted in May 2025, 4 years 3 months after primary completion.
Of 226 non-industry phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's 31 months is below that.
Counting every sponsor, half of 699 studies reached it within 50 months; a quarter within 31 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Pembrolizumab · Trametinib
Carcinoma, Non-Small-Cell Lung →
Jonathan Riess