Custom-Made vaccine aims to stop lung cancer recurrence

NCT ID NCT07683832

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests a personalized cancer vaccine, made specifically for each patient, to see if it is safe and can help prevent non-small cell lung cancer from coming back after surgery. The vaccine is given alone or together with an immunotherapy drug called toripalimab. The trial involves about 50 adults who have had their lung cancer surgically removed and are receiving standard post-surgery therapy.

What this could mean

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

Active substance
personalized cancer vaccine (ABO2109) and toripalimab (anti-PD-1 antibody)
What this could lead to
If successful, this approach could offer a new way to prevent lung cancer from returning after surgery by training the immune system to recognize and attack remaining cancer cells.
What could go wrong
This is an early-phase trial with only 50 participants, so results may not apply broadly. The vaccine is personalized, making it complex and costly, and side effects from immune activation or the combination therapy are possible.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 50 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 2031

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: Key inclusion criteria: * ≥18 years of age at time of informed consent * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 * Life expectancy of ≥6 months * Patient diagnosed with NSCLC and is receiving perioperative and/or adjuvant anti-cancer therapy. * Sufficient organ function * Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose. Exclusion Criteria: Key Exclusion Criteria: * For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously * Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer * Active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function. * Active infections * History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment * Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab * Positive pregnancy test or lactating women

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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 official record

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  2. A doctor treating you

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