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Immunotherapy combo shows promise for early lung cancer

NCT ID NCT04015778

Disease control Sponsor: Guangdong Association of Clinical Trials 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the immunotherapy drug nivolumab, alone or with chemotherapy, can shrink early-stage non-small cell lung cancer before surgery and help prevent it from coming back after surgery. About 316 people with stage II or IIIA lung cancer that can be removed will take part. The goal is to see if this approach improves outcomes and to learn more about how the immune system responds.

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 316 people

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

Started

Aug 2019

Expected to finish

Aug 2026

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: 1. Histologically confirmed Stage II or IIIA non-small cell lung cancer (NSCLC) (per TNM 8th edition; AJCC 8th edition), including T3N2M0 tumors, deemed to be completely resectable. 2. Regardless of PD-L1 expression status. 3. EGFR and ALK wild-type. If testing is performed, it should be conducted locally using assays approved by the National Medical Products Administration (NMPA/formerly CFDA). 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Presence of at least one measurable lesion according to RECIST version 1.1. Exclusion Criteria: 1. Presence of locally advanced, inoperable or metastatic disease 2. Participants with active, known or suspected autoimmune disease 3. Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) 4. EGFR mutation or ALK transsituation (+) Other protocol defined inclusion/exclusion criteria could 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.

Non-small cell lung cancer

Contacts and locations

Locations

  • Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

    Guangzhou, Guangdong, 510080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.