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Lung cancer combo aims to clear cancer DNA

NCT ID NCT07264673

Disease control Sponsor: Fondazione Ricerca Traslazionale Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tests whether adding OSE2101 (TEDOPI®) to standard maintenance therapy with cemiplimab can better clear cancer DNA from the blood in people with advanced non-small cell lung cancer. The study enrolls 160 participants who have a specific immune type (HLA-A2 positive) and have not progressed after initial chemo-immunotherapy. The main goal is to see if the combination increases ctDNA clearance rates compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cemiplimab and OSE2101 (TEDOPI®)
What this could lead to
If successful, this combination could improve ctDNA clearance and potentially delay cancer progression in NSCLC patients.
What could go wrong
This is an early phase II trial with only 160 participants, so results may not apply broadly. The treatment may not improve outcomes or could cause side effects.

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

About 160 people

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

Started

Apr 2025

Expected to finish

Oct 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 to 99 years

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 or cytologically confirmed diagnosis of non- oncogene addicted advanced, locally advanced (not suitable for definitive chemoradiation therapy) or metastatic non-small-cell lung cancer (NSCLC) * Any patient candidate for first line chemo-immunotherapy irrespective of PD-L1 levels * HLA-A2 positive * ECOG PS 0-1 * Signed informed consent (IC) prior to any trial-specific procedures Exclusion Criteria: * Patients not candidate for chemo-immunotherapy * HLA-A2 negative * Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated * Tumor tissue not available (archive or collected before trial inclusion) * Evidence of EGFR mutations or ALK or ROS1 rearrangements * Performance status \>1 (ECOG) * Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma(squamous or basaloid)

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NSCLC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena

    RECRUITING

    Roma, RM, 00144, Italy

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