Can PET scan signals predict who beats lung cancer with immunotherapy?

NCT ID NCT07084610

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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
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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.

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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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jan 2029

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: * 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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HC-FMRP-USP)

    RECRUITING

    Ribeirão Preto, São Paulo, 14040-906, Brazil

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