A Phase 2 interventional study of Cisplatin and Carboplatin in Non-small Cell Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Recruiting at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, 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 23rd largest by planned enrollment, is one of 9 that started in 2025, is one of 65 in phase 2, reaches primary completion later than 44 of the 47 other live ones, and was the 114th 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. 9 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 318 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:
H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 540 studies on the registry; 75 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
29 studies in Carcinoma, Non-Small-Cell Lung by H. Lee Moffitt Cancer Center and Research Institute: 2 open now, 6 under way, none of them phase 3. Of 20 finished, 12 (60%) have results posted.
Among the 29 studies in Carcinoma, Non-Small-Cell Lung by H. Lee Moffitt Cancer Center and Research Institute, this one has the largest planned enrollment of the 28 interventional ones that give a count, is the only one that started in 2025, is one of 8 in phase 2, and was the 29th registered.
H. Lee Moffitt Cancer Center and Research Institute’s Carcinoma, Non-Small-Cell Lung studies by the year they started, since 2003.
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 H. Lee Moffitt Cancer Center and Research Institute’s 29 in Carcinoma, Non-Small-Cell Lung:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a non-registrational, cohort study enrolling eligible Black patients diagnosed with histologically or cytologically, advanced/metastatic NSCLC without known EGFR/ALK/ROS1 tumor mutations, and who are ≥ 18 years of age, ECOG performance status 0-2, and may have detectable ctDNA at baseline.
Inclusion Criteria:
Cohorts 1, 2a and b: Exclusion Criteria:
Cohort 2a and b Only: Exclusion Criteria:
Has a diagnosis of immunodeficiency or is receiving systemic therapy at doses
≥ 10 mg prednisone or any other form of systemic therapy at C1D1. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted (i.e., ≤ 10 mg/day prednisone equivalents). A brief course (≤ 7 days) of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non- conditions (e.g., delayed-type reaction caused by contact allergen) is permitted.
Cohorts 1, 2a and b: 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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
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.
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.
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.
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 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.
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 other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
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.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Non-interventional prospective cohort and participants will receive standard of care pembrolizumab with or without chemotherapy.
Drug: Cisplatin · Drug: Carboplatin · Drug: Pemetrexed · Drug: Pembrolizumab · Drug: Abraxane · Drug: Paclitaxel
Cohort 2 Arm A will enroll patients with NSCLC with PD-L1 TPS status ≥1% and ctDNA tumor fraction low/negative and be treated with pembrolizumab monotherapy.
Drug: Pembrolizumab
Cohort 2 Arm B will enroll patients with NSCLC with any PD-L1 status and ctDNAtumor fraction intermediate/high -OR- PD-L1 TPS\<1% and any ctDNA level treated with chemotherapy plus pembrolizumab.
Drug: Cisplatin · Drug: Carboplatin · Drug: Pemetrexed · Drug: Pembrolizumab · Drug: Abraxane · Drug: Paclitaxel
Given on day 1 of every 21-day cycle.
Given on day 1 of every 21-day cycle.
Given on day 1 of every 21-day cycle.
Given on day 1 of every 21-day cycle. After cycle 4 is given every 6 weeks.
Given on days 1, 8, and 15 of each 21-day cycle.
Given on day 1 of every 21-day cycle.
Cohort 1: Real World Overall Survival (rwOS)
Real-world overall survival (rwOS) is defined as the length of time from the date the patient initiates treatment to the date of death or end of follow up, whichever occurred earliest.
Time frame: Up to 36 Months
Cohort 2 Arm A: Progression Free Survival (PFS)
Progression free survival is defined as the length of time from date of patient starts treatment to date of progression event or death.
Time frame: Up to 36 Months
Cohort 2 Arm B: Progression Free Survival (PFS)
Progression free survival is defined as the length of time from date of patient starts treatment to date of progression event or death.
Time frame: Up to 36 Months
Cohort 1: Baseline ctDNA
Baseline ctDNA will be summarized by mean, median, minimum, maximum, standard deviation, and coefficient of variation.
Time frame: At Baseline
Cohort 2: Arm A and Arm B Objective Response Rate (ORR)
Objective response rate will be determined by summing the rates of complete response and partial response.
Time frame: Up to 36 Months
Cohort 2: Arm A and Arm B Overall Survival (OS)
Overall Survival is defined as the length of time from the date the patient initiates treatment to the date of death or end of follow up, whichever occurred earliest.
Time frame: Up to 36 Months
Started Jun 2025 (actual). Primary completion is estimated for Jan 2030, 55 months after the start.
Of 730 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 84. This study's planned 55 months is close to that.
Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet 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.
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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 drug tested here: Pembrolizumab
Carcinoma, Non-Small-Cell Lung →
H. Lee Moffitt Cancer Center and Research Institute →