A Phase 2 interventional study of Pembrolizumab and Nab paclitaxel in Lung Cancer, Lung Cancer Metastatic and Brain Cancer, sponsored by John L. Villano, MD, PhD. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-10-31.
Sponsored by John L. Villano, MD, PhD · Phase 2, Interventional, and Treatment
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Among 39 studies testing pembrolizumab in Lung Neoplasms — 10 open to participants now, 22 under way, 9 of them phase 3. pembrolizumab · Lung Neoplasms.
Among the 39 studies testing pembrolizumab in Lung Neoplasms, this one is the 35th largest by enrollment, is one of 3 that started in 2022, is one of 22 in phase 2, and was the 20th registered.
5,423 studies on the registry are indexed under Lung Neoplasms; 1,345 are open to participants now.
Browse Lung Neoplasms studies →10 of the 39 studies testing pembrolizumab in Lung Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
University of Chicago · Sites in United States
Ages 18+
Boehringer Ingelheim · Sites in Australia, China, France and 5 more countries
Ages 18+
Latin American Cooperative Oncology Group · Sites in Brazil
Ages 18+
Second Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 18–75
Second Affiliated Hospital of Guangzhou Medical University · 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 995 Lung Neoplasms studies recruiting now, 682 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.
This study: 18 Years to 85 Years · 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 →
39 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 8 · Phase 2 25 · Phase 3 9
First in 2015; this study’s year is marked. 3 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3 is below the median of 60 across 3,657 interventional studies indexed under Lung Neoplasms.
Median enrollment 46 across the 39 interventional studies. Of the 14 that completed or were terminated, 10 (71%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 39 have an industry lead sponsor. The 10 most frequent:
John L. Villano, MD, PhD is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
John L. Villano, MD, PhD has 1 study filed under Lung Neoplasms — fewer than ten, so there is no comparison to draw.
6 of the studies testing pembrolizumab in Lung Neoplasms 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 |
| NCT03793179Phase 3National Cancer Institute (NCI)Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer | 2027-09-30 |
| NCT05493566Emory UniversityLow-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer | 2027-01-07 |
| NCT05384015Fundación GECPStudy of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung Cancer | 2027-07-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 39 studies testing pembrolizumab in Lung Neoplasms, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this study is to evaluate whether providing Pembrolizumab prolongs survival and preserves quality of life while minimizing side effects for patients with NSCLC with untreated asymptomatic brain metastasis.
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 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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
Patients will receive 200mg or 400mg of Pembrolizumab (standard of care dosing at the discretion of treating physician) over thirty minutes on day 1 every three or six weeks with standard of care chemotherapy treatment (carboplatin, pemetrexed, paclitaxel, nab-paclitaxel).
Drug: Pembrolizumab · Drug: Nab paclitaxel · Drug: Paclitaxel · Drug: Pemetrexed · Drug: Carboplatin
Pembrolizumab is an immunotherapy that can help fight certain cancers.
Also known as: Keytruda
Nab-paclitaxel is a taxane derivative that is an albumin-bound paclitaxel nanoparticle formulation that promotes microtubule assembly.
Paclitaxel is a taxane derivative that promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication.
Pemetrexed is an antifolate agent that disrupts folate-dependent metabolic processes essential for cell replication.
Carboplatin is a platinum compound alkylating agent which covalently binds to DNA and interferes with the function of DNA by producing interstrand DNA cross-links.
Disease Control Rate
Intracranial benefit defined as stable disease, partial response, and complete response
Time frame: 6 months (baseline to 6 months)
Number of Participants With Overall Survival at 12-month Post-enrollment
Overall survival at 12-month post-enrollment
Time frame: 12 months
Change in Extracranial Disease Control
Extracranial disease control rate (systemic): includes stable disease, partial response, and complete response.
Time frame: 12 months (6 months post-enrollment, 12 months post-enrollment)
Change in Patient-reported Cognitive Functioning - Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
The FACT-Cog questionnaire was developed to assess perceived cognitive function and impact on quality of life (QOL) in cancer patients. The level of perceived cognitive impairments is measured on a four-point Likert scale (4 = several times a day to 0 = never) FACT-Cog has been widely administered across clinical settings and validated across different cultures and languages. Subjects can complete it in 5 minutes. A higher score indicates a better quality of life/cognitive function.
Time frame: 12 months (Baseline and 12 months post enrollment)
Change in Quality of Life - Functional Assessment of Cancer Therapy-Brain (FACT-Br)
The FACT-Br is a commonly used instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 subscales. The level of well-being is measured on a four-point Likert scale (4 = very much to 0 = not at all). The measure yields information about total quality of life, as well as information about the dimensions of physical well-being, social/family well-being, emotional well-being, functional well-being, and disease-specific concerns. The score range is 0-200 where a higher score indicated a better quality of life. The FACT-Br is written at the 4th grade reading level, and subjects can complete it in 5-10 minutes.
Time frame: 12 months (Baseline and 12 months post enrollment)
Change in Quality of Life - FACIT Fatigue Scale (FACIT-F)
FACIT-F is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) with a score range of 0-52. Subjects can complete the questionnaire in 2-3 minutes and the higher the score, the better the quality of life.
Time frame: 12 months (Baseline and 12 months post enrollment)
Change in Mild Cognitive Impairment (MoCA)
Neurocognitive functioning will be evaluated utilizing the Montreal Cognitive Assessment (MoCA). MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Participants will complete the MoCA (estimated time 10 minutes). The MoCA is scored to obtain an item total, scores can range from 0 to 30 and score of 26 or above is considered normal.
Time frame: 12 months (Baseline and 12 months post enrollment)
Change in Performance Status
Participant performance status will be evaluated utilizing the Eastern Cooperative Oncology Group (ECGO) performance status instrument. Performance status is graded from 0-5 where lower scores indicate better performance/patient daily living abilities.
Time frame: 12 months (Baseline and 12 months post enrollment)
Immune Based Biomarker Activity
PD-1 and several immune-based markers, such as cytotoxic T cells, will be measured and summarized descriptively. Correlations with PD-1 and between markers will be estimated using Pearson or Spearman's correlation coefficient. Exploratory association of these biological markers with DCR will be performed using two-group comparison tests. Adjustment for multiple testing due to several immune-based markers will be considered using Holm's p-value adjustment method.
Time frame: 12 weeks (Baseline, 6 weeks after baseline, 6 weeks after prior collection)
| Milestone | Pembrolizumab with standard of care chemotherapy treatment |
|---|---|
| Started | 3 |
| Completed | 1 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Did not complete cycles | 1 |
Intracranial benefit defined as stable disease, partial response, and complete response
| Participants | Pembrolizumab with standard of care chemotherapy treatment |
|---|---|
| Stable Disease | 0 |
| Complete Response | 2 |
| Partial Response | 0 |
Overall survival at 12-month post-enrollment
| Participants | Pembrolizumab with standard of care chemotherapy treatment |
|---|---|
| Number of Participants With Overall Survival at 12-month Post-enrollment | 1 |
Extracranial disease control rate (systemic): includes stable disease, partial response, and complete response.
| Participants | Pembrolizumab with standard of care chemotherapy treatment |
|---|---|
| Change in Extracranial Disease Control | 1 |
The FACT-Cog questionnaire was developed to assess perceived cognitive function and impact on quality of life (QOL) in cancer patients. The level of perceived cognitive impairments is measured on a four-point Likert scale (4 = several times a day to 0 = never) FACT-Cog has been widely administered across clinical settings and validated across different cultures and languages. Subjects can complete it in 5 minutes. A higher score indicates a better quality of life/cognitive function.
No measurements were reported for this outcome.
The FACT-Br is a commonly used instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 subscales. The level of well-being is measured on a four-point Likert scale (4 = very much to 0 = not at all). The measure yields information about total quality of life, as well as information about the dimensions of physical well-being, social/family well-being, emotional well-being, functional well-being, and disease-specific concerns. The score range is 0-200 where a higher score indicated a better quality of life. The FACT-Br is written at the 4th grade reading level, and subjects can complete it in 5-10 minutes.
No measurements were reported for this outcome.
FACIT-F is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) with a score range of 0-52. Subjects can complete the questionnaire in 2-3 minutes and the higher the score, the better the quality of life.
No measurements were reported for this outcome.
Neurocognitive functioning will be evaluated utilizing the Montreal Cognitive Assessment (MoCA). MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Participants will complete the MoCA (estimated time 10 minutes). The MoCA is scored to obtain an item total, scores can range from 0 to 30 and score of 26 or above is considered normal.
No measurements were reported for this outcome.
Participant performance status will be evaluated utilizing the Eastern Cooperative Oncology Group (ECGO) performance status instrument. Performance status is graded from 0-5 where lower scores indicate better performance/patient daily living abilities.
No measurements were reported for this outcome.
PD-1 and several immune-based markers, such as cytotoxic T cells, will be measured and summarized descriptively. Correlations with PD-1 and between markers will be estimated using Pearson or Spearman's correlation coefficient. Exploratory association of these biological markers with DCR will be performed using two-group comparison tests. Adjustment for multiple testing due to several immune-based markers will be considered using Holm's p-value adjustment method.
Results for this outcome have not been posted.
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab with standard of care chemotherapy treatment | 1/3 (33.3%) | 0/3 (0%) | 2/3 (66.7%) |
| Event | Pembrolizumab with standard of care chemotherapy treatment |
|---|---|
| FatigueGeneral disorders | 2/3 |
| Atrial FibrillationCardiac disorders | 1/3 |
| Cardiac disorders - OtherCardiac disorders | 1/3 |
| PalpitationsCardiac disorders | 1/3 |
| NauseaGastrointestinal disorders | 1/3 |
| ConstipationGastrointestinal disorders | 1/3 |
| Flu like symptomsGeneral disorders | 1/3 |
| OtherGeneral disorders | 1/3 |
| SinusitisInfections and infestations | 1/3 |
| Tooth infectionInfections and infestations | 1/3 |
| Age, Categorical(Participants) | Pembrolizumab with standard of care chemotherapy treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 2 |
| Sex: Female, Male(Participants) | Pembrolizumab with standard of care chemotherapy treatment |
|---|---|
| Female | 2 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | Pembrolizumab with standard of care chemotherapy treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Pembrolizumab with standard of care chemotherapy treatment |
|---|---|
| United States | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2022 to primary completion in Jun 2023, 13 months.
Results were first posted in Oct 2024, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 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.
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Studies of the drug tested here: Pembrolizumab
John L. Villano, MD, PhD