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Triple-Drug attack before lung surgery shows promise in early trial

NCT ID NCT07567326

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tests whether adding a PCSK-9 inhibitor (recaticimab) to standard immunotherapy and chemotherapy before surgery can improve outcomes for people with resectable non-small cell lung cancer. About 78 participants will receive either adebrelimab or retlirafusp alfa plus recaticimab and chemo, then undergo surgery. The main goal is to see how many patients have no cancer cells left in the removed tissue (pathological complete response).

What this could mean

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

Active substance
Adebrelimab or retlirafusp alfa (SHR-1701) plus recaticimab and chemotherapy
What this could lead to
If successful, this combination could improve the chance of eliminating all cancer before surgery and potentially extend survival for people with resectable non-small cell lung cancer.
What could go wrong
This is an early phase 2 trial with only 78 participants, so results may not apply to everyone. Adding more drugs also raises the risk of side effects, and the benefit over standard treatment is not yet proven.

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 78 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

Dec 2030

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 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: * 18-75 years old * Histologically or cytologically confirmed resectable stage II, IIIA, or selected IIIB (T2-3N2bM0 only) non-small cell lung cancer (NSCLC) according to the International Union Against Cancer (UICC) and American Joint Committee on Cancer (AJCC) 9th edition TNM classification for lung cancer, with the tumor judged by the investigator as amenable to curative-intent R0 resection. * Ability to provide tumor tissue specimens, either archived or freshly obtained prior to the first dose of study drug. * Presence of measurable target lesions by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST version 1.1. Tumor imaging assessment must be performed within 28 days before the first dose. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * No prior anti-cancer therapy, including radiotherapy, chemotherapy, surgery, or targeted therapy, before study enrollment. * Adequate hematologic and end-organ function. Exclusion Criteria: * Histologically or cytologically confirmed small cell lung cancer (SCLC), mixed SCLC and NSCLC, or other non-NSCLC pathological types. * Known EGFR mutations or ALK positivity, or other actionable driver gene mutations for which approved targeted therapies are available and accessible. * Presence of malignant pleural effusion. For subjects with drainable pleural effusion during the screening period, at least one thoracentesis is required to rule out the presence of malignant cells. * Prior systemic anti-cancer therapy for non-small cell lung cancer. If the subject has previously received anti-cancer treatment with traditional Chinese medicine (TCM), enrollment is permitted only if the interval between the completion of TCM therapy and the first dose of study drug is at least 2 weeks. * Receipt of systemic immunosuppressive therapy within 2 weeks prior to the first dose, or expected need for systemic immunosuppressive medication during the study treatment period. * Current participation in an interventional clinical study treatment, or receipt of another investigational drug or investigational device within 4 weeks prior to the first dose. * History of malignancies other than NSCLC within 5 years prior to enrollment. * Presence of autoimmune disease. * Subjects with known or suspected interstitial lung disease; other moderate to severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity or significantly impair respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obstructive bronchiolitis, etc. * Subjects with severe cardiovascular or cerebrovascular diseases. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose. * Arterial or venous thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) within 3 months prior to the first dose. * Congenital or acquired immunodeficiency, including but not limited to human immunodeficiency virus (HIV) infection, active hepatitis B, or hepatitis C. * Evidence of active tuberculosis infection within 1 year prior to the first dose. * Severe infection within 4 weeks prior to the first dose. * Receipt of live attenuated vaccine within 28 days prior to the first dose, or planned receipt of live attenuated vaccine during the study period. * Major surgery (other than diagnostic procedures or biopsy) within 28 days prior to the first dose. * History of or planned allogeneic bone marrow transplantation or solid organ transplantation. * History of severe hypersensitivity reactions to other monoclonal antibodies or fusion proteins, or known allergy to any component of the randomly assigned treatment regimen. * Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period. * Known history of substance abuse, alcohol abuse, or drug addiction.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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