A Phase 1 interventional study of Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) and Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in Metastatic Non-small-cell lunG Cancer, sponsored by Royal Marsden NHS Foundation Trust. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Royal Marsden NHS Foundation Trust · Phase 1, Interventional, and Treatment
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Among 10 studies in Carcinoma, Non-Small-Cell Lung by Royal Marsden NHS Foundation Trust — 2 open to participants now, 3 under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · Royal Marsden NHS Foundation Trust.
Among the 10 studies in Carcinoma, Non-Small-Cell Lung by Royal Marsden NHS Foundation Trust, this one is one of 2 that started in 2018, is one of 2 in phase 1, and was the 7th 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 →2 of the 10 studies in Carcinoma, Non-Small-Cell Lung by Royal Marsden NHS Foundation Trust are open now, in 1 country. Recruiting first, the newest first:
Royal Marsden NHS Foundation Trust · Sites in United Kingdom
Ages 18+
Royal Marsden NHS Foundation Trust · Sites in United Kingdom
Ages 18+
By country, each count listing its studies:
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.
10 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 4 · Phase 2 3 · Phase 3 2
First in 1998; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2 is below the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 60 across the 7 interventional studies, 75 across the 2 observational. Of the 2 that completed or were terminated, 2 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
Royal Marsden NHS Foundation Trust is the lead sponsor of 274 studies on the registry; 53 are open to participants now.
1 of the studies in Carcinoma, Non-Small-Cell Lung by Royal Marsden NHS Foundation Trust that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07673861Royal Marsden NHS Foundation TrustClinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients | 2026-12-31 |
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Among the 10 studies in Carcinoma, Non-Small-Cell Lung by Royal Marsden NHS Foundation Trust, from their registry updates:
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 single centre non-randomised open label phase 1 trial of lung SBRT to part of a lung lesion in patients with advanced NSCLC in combination with pembrolizumab. This study will recruit up to 24 patients whose lung cancer has progressed beyond one line of palliative chemotherapy, and an EGFR or ALK inhibitor if an EGFR driver mutation or ALK gene rearrangement is present, respectively, and now requires further palliative systemic treatment.
The study will be conducted in two parts; an initial lung SBRT dose escalation phase (Part A), followed by a lung SBRT dose expansion cohort (Part B). The dose escalation phase is based on a 3+3 design such that patients will be treated in cohorts of 3-6 patients. A maximum of 12 patients will be allocated to one of two doses of lung SBRT in combination with pembrolizumab to determine the MTD, DLTs and RP2D. If there is more than one DLT in cohort 1, this treatment combination will be deemed as being unacceptable, and it would lead to termination of the study. Note, there is no de-escalation in cohort 1. During the dose expansion cohort, 12 patients will have lung SBRT dosed at the RP2D determined during the dose escalation phase in combination with pembrolizumab to obtain additional safety and response data. Maintenance pembrolizumab will continue until disease progression, unacceptable toxicities, the patient withdraws consent to the trial, or the patient has completed 24 months of treatment. A maximum of 24 patients will be treated in the study.
All patients will receive pembrolizumab on cycle (C) 1 day (D) 1, in Part A and B of the study. All patients will receive lung SBRT on C1D15, C1D17, and C1D19 as per lung SBRT protocol (See Appendix 3). Although C1D1 can occur +/- 3 days, C1D15, C1D17, and C1D19, must be scheduled for a Monday, Wednesday and Friday, respectively. Patients in part A will receive lung SBRT dosed at 30 Gy in 3# in cohort 1, or 54 Gy in 3# in cohort 2. Patients in Part B will receive the RP2D of lung SBRT, determined in Part A. All patients in Part A and Part B will receive pembrolizumab dosed at 200 mg every 3 weeks, until disease progression, unacceptable toxicities, the patient withdraws consent from the trial, or the patient has completed 24 months of treatment.
In the dose escalation phase, a minimum of 3 patients will be required per dose level being assessed. A minimum gap of 1 week will be left between the treatment of the first and the second, and between the second and the third patients with the combination of pembrolizumab and lung SBRT to mitigate against multiple patients suffering from acute toxicity. The DLT period for this study is 12 weeks from the last dose of lung SBRT (i.e. at C6D1). The dose escalation will be considered by the Safety Review Committee (SRC) once the 3rd or 6th patient in the cohort has completed the DLT period. If no DLT is observed at a dose level, then lung SBRT will be dose escalated to the next dosing level (see Table 1). If 1 out of 3 patients experience a DLT, then the cohort will be expanded to 6 patients. If 1 in 6 patients experience a DLT, then the dose will be escalated to the next dosing level. However, if ≥ 2 in 6 patients experience a DLT then the maximum administered dose (MAD) will have been reached, and the RP2D will be the previous dosing level that will be used for the dose expansion cohorts. If the MAD is seen at dose level 1 then the study will be terminated. While waiting for 3 or 6 patients to complete the DLT period, no additional patients will be recruited. Further patients can only be recruited after the SRC has reviewed the toxicity data for the cohort and taken a decision to dose escalate to the next cohort or expand the current cohort to 6 patients.
Once the MTD has been determined the trial enters the dose expansion phase (unless the MTD is dose level 1). Here, 12 patients will be treated with the RP2D of SBRT combined with pembrolizumab.
If there is ongoing clinical benefit at 24 months, the CI/PI will need to discuss with the sponsor and MSD, on a case by case basis for the continuation of pembrolizumab.
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.
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 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.
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.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
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.
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.
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.
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.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Radiation: Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) · Drug: Pembrolizumab
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Radiation: Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) · Drug: Pembrolizumab
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Radiation: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose · Drug: Pembrolizumab
Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
Pembrolizumab in week 1 dosed at 200 mg (prior to SBRT) and then treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks.
Also known as: Keytruda
Proportion of Patients With Dose Limiting Toxicity
Proportion of all treated patients who have experience at least one Dose Limiting Toxicity (DLT). DLT is assessed using NCI CTCAE v4.0 and defined as any one or more of: neutropenia with fever grade \>=3; thrombocytopenia with bleeding grade \>=3; any grade \>=3 non-haematological toxicity which is definitely, probably, or possibly related to the trial treatment.
Time frame: From first dose of Pembrolizumab to 12 weeks from the last dose of lung SBRT
Acute Toxicity Rate
Percentage of patients any acute toxicity, by worst grade as assessed using CTCAE v4.0
Time frame: From first dose of Pembrolizumab to 12 weeks from the last dose of lung SBRT
Late Toxicity Rate
Percentage of patients with any late toxicity, by worst grade as assessed using CTCAE v4.0
Time frame: Assessed at start of each 21 day pembrolizumab cycle, starts from 12 weeks after last fraction of lung SBRT and ends 28 days after last on-trial dose of pembrolizumab (treatment ended at disease progression for all trial patients), up to 6 months
Overall Response Rate
Count of patients with best overall response of complete or partial response at any time, assessed using RECIST v1.1
Time frame: Response assessed from start of pembrolizumab, every 9 weeks for the first 6 months, then every 12 weeks thereafter, until the first instance of documented disease progression (occurred no later than 7 months from start of treatment for all patients)
Disease Control Rate
Count of patients with best overall response at any time of complete or partial response, or stable disease, assessed by RECIST v1.1
Time frame: Response assessed from start of pembrolizumab, every 9 weeks for the first 6 months, then every 12 weeks thereafter, until the first instance of documented disease progression (occurred no later than 7 months from start of treatment for all patients)
Overall Response Rate (irRECIST)
Count of patients with best response of complete or partial response, assessed using Immune Related Response Criteria (irRC) as defined by: Wolchok JD et al. Guidelines for the evaluation of immune therapy activity in solid tumors: Immune related response criteria. Clin Cancer Res 2009;15(23):7412. (72)
Time frame: Response assessed from start of pembrolizumab, every 9 weeks for the first 6 months, then every 12 weeks thereafter, until the first instance of documented disease progression, start of new anti-cancer treatment, death or end of study
Frequency of PD-1/PD-L1 Expression
PD-1/PD-L1 expression distribution in responders and non-responders
Time frame: Response to be defined as per previous endpoint, PD1/PD-L1 to be measured at study entry
Overall Survival at Six Months
Count of patients known to be alive at six months
Time frame: 6 months after last dose of lung SBRT
Overall Survival at 12 Months
Count of patients known to be alive at 12 months
Time frame: 12 months after last dose of lung SBRT
Progression Free Survival at 6 Months
Count of patients known to be alive and free from progression at 6 months
Time frame: 6 months after last dose of lung SBRT
Progression Free Survival at 12 Months
Count of patients known to be alive and free from progression at 12 months
Time frame: 12 months after last dose of lung SBRT
During the period between June 2018 and January 2019, 2 patients were recruited to the study at the Royal Marsden Hospital in the United Kingdom.
| Milestone | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort |
|---|---|---|---|
| Started | 2 | 0 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 2 | 0 | 0 |
| Withdrew: Lack of efficacy | 2 | 0 | 0 |
Proportion of all treated patients who have experience at least one Dose Limiting Toxicity (DLT). DLT is assessed using NCI CTCAE v4.0 and defined as any one or more of: neutropenia with fever grade \>=3; thrombocytopenia with bleeding grade \>=3; any grade \>=3 non-haematological toxicity which is definitely, probably, or possibly related to the trial treatment.
| Participants | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort |
|---|---|---|---|
| Proportion of Patients With Dose Limiting Toxicity | 0 | — | — |
Percentage of patients any acute toxicity, by worst grade as assessed using CTCAE v4.0
| Participants | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort |
|---|---|---|---|
| Patients with max grade 3 toxicity | 0 | — | — |
| Patients with max grade 2 toxicity | 1 | — | — |
| Patients with max grade 1 toxicity | 1 | — | — |
Percentage of patients with any late toxicity, by worst grade as assessed using CTCAE v4.0
| Participants | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort |
|---|---|---|---|
| Patients with max grade 3 toxicity | 1 | — | — |
| patients with max grade 2 toxicity | 0 | — | — |
| Patients with max grade 1 toxicity | 1 | — | — |
Count of patients with best overall response of complete or partial response at any time, assessed using RECIST v1.1
| Participants | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort |
|---|---|---|---|
| Overall Response Rate | 0 | — | — |
Count of patients with best overall response at any time of complete or partial response, or stable disease, assessed by RECIST v1.1
| Participants | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort |
|---|---|---|---|
| Disease Control Rate | 2 | — | — |
Count of patients with best response of complete or partial response, assessed using Immune Related Response Criteria (irRC) as defined by: Wolchok JD et al. Guidelines for the evaluation of immune therapy activity in solid tumors: Immune related response criteria. Clin Cancer Res 2009;15(23):7412. (72)
No measurements were reported for this outcome.
PD-1/PD-L1 expression distribution in responders and non-responders
No measurements were reported for this outcome.
Count of patients known to be alive at six months
| Participants | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort |
|---|---|---|---|
| Overall Survival at Six Months | 2 | — | — |
Count of patients known to be alive at 12 months
| Participants | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort |
|---|---|---|---|
| Overall Survival at 12 Months | 1 | — | — |
Count of patients known to be alive and free from progression at 6 months
| Participants | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort |
|---|---|---|---|
| Progression Free Survival at 6 Months | 1 | — | — |
Count of patients known to be alive and free from progression at 12 months
| Participants | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort |
|---|---|---|---|
| Progression Free Survival at 12 Months | 0 | — | — |
Collected over Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Escalation Cohort - DOSE LEVEL 1 | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Dose Escalation Cohort - DOSE LEVEL 2 | — | — | — |
| Part B - Expansion Cohort | — | — | — |
| Event | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort |
|---|---|---|---|
| FatigueGeneral disorders | 2/2 | — | — |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/2 | — | — |
| CoughRespiratory, thoracic and mediastinal disorders | 2/2 | — | — |
| Sinus tachycardiaCardiac disorders | 1/2 | — | — |
| DyspepsiaGastrointestinal disorders | 1/2 | — | — |
| Abdominal painGastrointestinal disorders | 1/2 | — | — |
| NauseaGastrointestinal disorders | 1/2 | — | — |
| Flu like symptomsGeneral disorders | 1/2 | — | — |
| Urinary tract infectionInfections and infestations | 1/2 | — | — |
| Upper respiratory infectionInfections and infestations | 1/2 | — | — |
No participants were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort.
| Age, Categorical(Participants) | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort | Total |
|---|---|---|---|---|
| <=18 years | 0 | — | — | 0 |
| Between 18 and 65 years | 0 | — | — | 0 |
| >=65 years | 2 | — | — | 2 |
| Sex: Female, Male(Participants) | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort | Total |
|---|---|---|---|---|
| Female | 1 | — | — | 1 |
| Male | 1 | — | — | 1 |
| Race (NIH/OMB)(Participants) | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | — | — | 0 |
| Asian | 0 | — | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | — | 0 |
| Black or African American | 0 | — | — | 0 |
| White | 2 | — | — | 2 |
| More than one race | 0 | — | — | 0 |
| Unknown or Not Reported | 0 | — | — | 0 |
| Region of Enrollment(participants) | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort | Total |
|---|---|---|---|---|
| United Kingdom | 2 | — | — | 2 |
| Eastern Cooperative Oncology Group (ECOG)(Participants) | Dose Escalation Cohort - DOSE LEVEL 1 | Dose Escalation Cohort - DOSE LEVEL 2 | Part B - Expansion Cohort | Total |
|---|---|---|---|---|
| 0 = Normal activity. | 0 | — | — | 0 |
| 1 = Symptoms but ambulatory. | 2 | — | — | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Jul 2019, 16 months.
Results were first posted in Jan 2026, 6 years 6 months after primary completion.
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Carcinoma, Non-Small-Cell Lung →
Royal Marsden NHS Foundation Trust →