Can PET scan signals predict who beats lung cancer with immunotherapy?
NCT ID NCT07084610
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are investigating whether metabolic markers measured by PET/CT scans and tumor tissue tests can predict how well early-stage non-small cell lung cancer responds to immunotherapy given before surgery. Thirty patients with stage IB to IIIA NSCLC that lacks EGFR and ALK mutations will receive two cycles of nivolumab plus platinum-based chemotherapy, then undergo robotic-assisted lung surgery. The study tracks major pathological response, immune cell profiles, event-free survival, and treatment toxicity to see if lower glycolytic activity in tumors aligns with better outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab combined with platinum-based chemotherapy
- What this could lead to
- If the markers predict response, doctors could use routine PET scans and tissue tests to pick which early-stage lung cancer patients benefit most from immunotherapy before surgery, sparing others the side effects and cost.
- What could go wrong
- This is a small, single-center study of 30 patients with no control group, so the marker-response link may not hold in larger or more diverse populations. Immunotherapy plus chemotherapy carries risks of immune-related side effects and complications from lung surgery.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jan 2029
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: * Histologically confirmed non-small cell lung cancer (NSCLC), clinical stage IB to IIIA (according to AJCC 8th edition) * Tumor deemed resectable by the multidisciplinary thoracic oncology team * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ and bone marrow function * Ability to understand and willingness to sign a written informed consent Exclusion Criteria: * Prior systemic therapy, radiotherapy, or immunotherapy for lung cancer * Known EGFR mutations or ALK rearrangements * Active autoimmune disease requiring systemic therapy within the past 2 years * Uncontrolled comorbidities or active infections * Pregnant or breastfeeding women * Contraindications to surgery or anesthesia * Known history of other malignancies within the last 3 years, except for adequately treated basal or squamous cell skin cancer, or carcinoma in situ of the cervix
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HC-FMRP-USP)
RECRUITINGRibeirão Preto, São Paulo, 14040-906, Brazil
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