Could lung cancer patients get immunotherapy less often?

NCT ID NCT04032418

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study tests whether giving the immunotherapy drug pembrolizumab every 12 weeks works as well as the standard every 3 weeks in people with non-small cell lung cancer who are already benefiting from the drug. The goal is to see if fewer treatments can keep the cancer under control while reducing hospital visits and costs. About 9 participants are enrolled in this phase 2 trial.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

9 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 at the time of study treatment initiation. * Have pathologically confirmed diagnosis of non-small cell lung cancer (NSCLC). Mixed small cell lung cancer (SCLC) histology is not allowed. * Must be eligible for treatment with pembrolizumab as standard of care (up to third line). * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L. * Platelets \>= 100 x 10\^9/L. * Hemoglobin \>= 9 g/dL. * Plasma creatinine =\< 1.5 x institution upper limit of normal (ULN) or estimated glomerular filtration rate (GFR) (measured or calculated with Cockcroft and Gault formula) \> 45 ml/min. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (ALT and AST =\< 5 x ULN is acceptable if liver metastases are present). * Total plasma bilirubin =\< 1.5 x ULN. For patients with well documented Gilbert?s syndrome, total bilirubin =\< 3 x ULN with direct bilirubin within normal range. * Must have demonstrated complete response, partial response by Response Evaluation Criteria in Solid Tumors (RECIST) or stable disease if \> 5% but less than 30% decrease from baseline total tumor burden (target lesions) to pembrolizumab at the time of randomization for study treatment.Patients with new brain metastasis isolated in the brain while on pembrolizumab monotherapy will be eligible as long as extracranial disease control fulfills the criteria otherwise (i.e. this will not be considered as disease progression for the purpose of this study). * Must have received at least 6 months of pembrolizumab monotherapy treatment (but no more than 15 months total duration, including treatment in combination with chemotherapy prior to maintenance phase) prior to start of protocol-assigned treatment. * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: * Receipt of anticancer chemotherapy, other than pembrolizumab, within 6 months prior to randomization. * Disease progression to pembrolizumab as assessed by immune related (ir)RECIST. * Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis. Subjects must have recovered from all radiation related toxicities. * Active/untreated brain metastasis. Whole brain radiation or gamma knife radiosurgery performed less than 4 weeks prior to first administration of study drug. Previously treated brain metastasis allowed as long as not requiring steroids and stable on imaging at least 4 weeks after completing radiation therapy. * Leptomeningeal involvement regardless of tumor response status. * Tumor with mutation that is known to be sensitive to Food and Drug Administration (FDA)- approved targeted therapy. * Patients who had pembrolizumab interrupted for more than 4 weeks for management of treatment-related adverse event. * Currently receiving or has received high-dose systemic corticosteroids within 4 weeks prior to starting study drug for management of brain metastases, or who have not fully recovered from side effects of such treatment. Patients who are on low-dose prednisone (10 mg once daily or less) for at least 6 months for the management of other chronic disorders (e.g. chronic obstructive pulmonary disease \[COPD\]) is allowed. Steroids for endocrine replacement or receipt of short-course of steroids during the preceding 4 week period as supportive medication such as for drug allergy, anti-emetic, etc. is allowed. * Had major surgery within 14 days prior to starting protocol treatment. * Active, clinically serious infections or other serious uncontrolled medical conditions. * Pregnant or nursing female participants. * Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study drug. * Unwilling or unable to follow protocol requirements.

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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

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

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Other studies related to the condition(s) this trial covers.