Experimental combo for advanced lung cancer shows early promise but trial halted
NCT ID NCT03436056
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested the combination of the immunotherapy drug pembrolizumab (Keytruda) with precise, high-dose radiation (SBRT) in patients with advanced non-small cell lung cancer that had progressed after chemotherapy. The study aimed to find the safest radiation dose and check for severe side effects. Only 2 patients were enrolled before the trial was terminated, so no firm conclusions can be drawn about effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pembrolizumab (Keytruda) and stereotactic body radiotherapy (SBRT)
- What this could lead to
- If it works, this could point toward a new combination treatment for advanced lung cancer that has stopped responding to standard chemotherapy.
- What could go wrong
- This is a very early phase 1 trial that was terminated after only 2 participants, so results are extremely limited. The combination may cause serious side effects like low blood counts or organ inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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2 people
The number who actually took part.
- Started
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Mar 2018
- Finished
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Jul 2019
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients should be ≥18 years old on the day of signing the informed consent. 2. Patients must have a histological or cytological diagnosis of NSCLC. 3. Patients should have non-radically treatable stage IIIB or IV disease. 4. Patients must have measurable disease as assessed by RECIST v1.1. 5. Patients must have had disease progression or be intolerant of standard first line palliative chemotherapy for non-small cell lung cancer. If they are known to have a driver mutation for which there is a small molecule targeted therapy, they must have had disease progression or be intolerant of this. 6. Patient should have an ECOG performance status 0-1. 7. Patients should be able to tolerate a course of stereotactic radiotherapy as assessed by the investigator. 8. Patients should have disease within the lung, away from critical structures, suitable for treatment to part of a lesion with lung SBRT. 9. Patients must have adequate organ function including MRC dyspnoea score \<3 and adequate baseline lung function tests, with an FEV1 \> 0.8L or \>30% of predicted and a TLCO \> 30% 10. Demonstrate adequate organ function (based on bloods within 10 days of C1D1). 11. Have provided tissue from an archival tissue sample or newly obtained tissue sample. 12. Female patient of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication (C1D1). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 13. Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. 14. Male patients should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. 15. Be willing to provide informed consent for the trial. Exclusion Criteria: 1. Patients who have taken any investigational medicinal product or have used an investigational device within 4 weeks of the first dose of pembrolizumab. Patients may participate in additional observational studies. 2. Patients who have received prior chemotherapy, targeted small molecule therapy or radiotherapy within 4 weeks prior to the first dose of pembrolizumab. 3. Patients with a diagnosis of immunodeficiency or be receiving systemic steroid therapy (\>7.5 mg of prednisone / \>1 mg of dexamethasone or their equivalent dose) or any other form of immunosuppressive therapy within 7 days prior to the first dose. 4. Patients with evidence of active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. 5. Patients who have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). 6. Patients with evidence of active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided the brain metastases are stable and there is no evidence of new or enlarging brain metastases. 7. Patients who have had previous radiotherapy to the lung or other neighbouring region that would preclude the safe administration of lung SBRT. 8. Patients with evidence of interstitial lung disease, or history of pneumonitis (including non-infectious pneumonitis) that required steroids, or current pneumonitis (including non-infectious pneumonitis). 9. Patients with evidence of additional malignancy that is progressing or requires active treatment. 10. Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound trial results, interfere with the patient's participation or is not in the best interest of the patient. 11. Patients with psychiatric or substance abuse disorders that would interfere with patient's participation. 12. Patients who are pregnant / breastfeeding or expecting to conceive within the duration of the trial, starting with the screening visit through 120 days after the last dose. 13. Patients with a history of HIV, HIV 1/2 antibodies, Hepatitis B or Hepatitis C. 14. Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment. 15. Patients with known hypersensitivity to the active substance pembrolizumab or to any of the excipients listed in the SmPC.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
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Other studies related to the condition(s) this trial covers.
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