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Immunotherapy combo shows promise against early lung cancer in small trial

NCT ID NCT05775796

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 trial tested the drug serplulimab (an immunotherapy) combined with standard chemotherapy in 30 people with stage II-IIIA non-small cell lung cancer that could be surgically removed. The treatment was given before and after surgery to see if it could shrink tumors and improve outcomes. The study is complete, and results will help determine if this combination is safe and effective enough for larger trials.

What this could mean

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

Active substance
Serplulimab combined with chemotherapy (paclitaxel or pemetrexed plus cisplatin or carboplatin)
What this could lead to
If successful, this could point toward a more effective treatment approach for early-stage lung cancer, potentially improving surgical outcomes and reducing recurrence.
What could go wrong
This is a small, early-phase trial with only 30 participants and no comparison group, so results may not be conclusive. The combination therapy also carries risks of side effects from both immunotherapy and chemotherapy.

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

30 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2025

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 75 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: * stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue. * Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities. * Eligible male and female subjects aged 18-75 years. * Lung function capacity capable of tolerating the proposed lung surgery. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. * Available tissue of primary lung tumor. Exclusion Criteria: * Presence of locally advanced, inoperable or metastatic disease. * Subjects with EGFR mutation or ALK、ROS1 gene rearrangement. * Active, known or suspected autoimmune disease. * Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors). Other protocol defined inclusion/exclusion criteria apply

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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.

Immunotherapy Neoadjuvant therapy Non-small cell lung cancer Stage II-IIIA

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

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