Morning infusions may boost lung cancer treatment
NCT ID NCT06882174
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looks at whether giving pembrolizumab infusions in the morning improves outcomes for people with metastatic non-small cell lung cancer. 58 participants will be randomly assigned to morning or standard scheduling. The goal is to see if timing affects how long the cancer stays under control and if this approach is practical for a larger trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pembrolizumab
- What this could lead to
- If timing matters, this could improve survival without extra cost or side effects, and lead to a larger study.
- What could go wrong
- This is a small pilot study, not yet recruiting. The benefit of timing is unproven, and results may not change standard care.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- 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 with histologic diagnosis mNSCLC with PDL1 staining ≥ 50% on standard of care IHC testing 2. Patients must be eligible for treatment with standard-of-care pembrolizumab 3. Patients must be 18 years of age or older. 4. Patients must be capable of providing consent to enrolment and willing to comply with study, treatment and follow-up. 5. Patients with a performance status of Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Oken et al., 1982) will be eligible for enrolment 6. Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 7 days prior to the first dose of pembrolizumab. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. 7. Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard. 8. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial. 9. The following adequate organ function laboratory values must be met: Hematological: * Absolute neutrophil count (ANC) \>1.0 * Platelet count \>100 * Hemoglobin \>90 mg/dL Renal: o Serum creatinine \<3x upper limited of normal (ULN) Hepatic: * Total serum bilirubin \<2x ULN * AST and ALT \<3x ULN Coagulation: o International Normalized Ratio (INR) \<1.5x ULN (unless patient is receiving anticoagulant therapy and if PT or PTT is within therapeutic range of intended use of anticoagulants) Exclusion Criteria: 1. Concurrent therapy with systemic therapy other than pembrolizumab (such as chemotherapy, targeted therapy, other checkpoint inhibitors, or hormonal therapy). 2. Treatment plan includes local therapy such as radiation or surgery. 3. Untreated symptomatic brain metastases, or previously treated brain metastases requiring corticosteroids for symptom control. Patients with untreated asymptomatic brain metastases, where all lesions are \< 2cm in size with no vasogenic edema, are eligible. 4. Presence of leptomeningeal disease. 5. Known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C. Testing for HIV, HBV or HCV is not mandatory for enrolment to study but may occur at the discretion of the investigator. 6. Active autoimmune disease that has required systemic treatment in past 12 months (i.e. with use of disease modifying agents, requiring \>10mg prednisone or equivalent or other immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 7. Participant unwilling to agree to their treatment times being scheduled as per study protocol during the study treatment period (Cycles 1-6).
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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