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New drug combo aims to shrink lung tumors enough for surgery

NCT ID NCT07408635

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This phase II trial tests whether a new drug called IBI363, combined with standard chemotherapy, can shrink stage III non-small cell lung cancer that was initially too advanced to remove with surgery. The goal is to make the tumors operable, then remove them. About 43 adults with unresectable stage III NSCLC will receive the combination before a surgical evaluation. The study measures how many patients achieve complete tumor removal and how well they respond.

What this could mean

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

Active substance
IBI363 (a drug that targets PD-1 and IL-2) combined with platinum-based chemotherapy
What this could lead to
If successful, this approach could turn some inoperable lung cancers into operable ones, potentially improving survival and cure rates.
What could go wrong
This is a small, early-phase trial with only 43 participants and no comparison group. The combination may cause significant side effects, and not all patients will become eligible for surgery.

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 43 people

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

Started

Jan 2026

Expected to finish

Jan 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 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. The patient shall sign the informed consent. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4. Histologically or cytologically confirmed Stage III (per AJCC 9th) squamous or non-squamous non-small-cell lung cancer (NSCLC) deemed unresectable by the investigator. 5. Tumours with mixed NSCLC histology must be categorised as either squamous or non-squamous on the basis of the predominant component. Tumours containing both NSCLC and small-cell lung cancer (SCLC) are excluded. 6. "Unresectable" is defined as following: (1) Multistation or confluent metastasis in ipsilateral mediastinal lymph nodes (2)Contralateral or supraclavicular lymph node metastasis (N3) (3)Invasion of critical organs or major blood vessels (4)Extensive invasion of the chest wall and pleura (5)Special anatomical locations (6)Patient intolerance to lobectomy or pneumonectomy. 7. At least one measurable lesion per RECIST v1.1. 8. Adequate organ function meet the following standards (within 14 days before first dose, any blood components or growth factor drugs is not permitted): * ANC count ≥ 1.5 × 10⁹/L * Platelet count ≥ 100 × 10⁹/L * Hemoglobin ≥ 90 g/L * Serum Cr ≤ 1.5 times of upper limit of normal (ULN) or calculated creatinine clearance (CLcr) ≥ 50 mL/min * Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN in Gilbert's syndrome) * AST and ALT ≤ 2.5 × ULN * INR or APPT ≤ 1.5 × ULN * left ventricular ejection fraction (LVEF) ≥ 50 % 9. Contraception and reproductive status: 10. Fertile female patients must voluntarily use effective contraception during the study period and for at least 3 months after treatment completion, and urine or serum pregnancy test result within 72 hours prior to enrollment are negative and must not be breastfeeding. Male patients with female partners of childbearing potential must use effective contraception during the trial and for 3 months after the last dose of IBI363. EXCLUSION CRITERIA 1. Non-squamous and squamous NSCLC with EGFR active mutation positive, ALK rearrangement, or any other driver mutation with an approved targeted therapy. 2. History of other malignant tumors within five years or concurrently present, except adequately treated cervical carcinoma in situ, basal- or squamous-cell skin carcinoma, localized prostate cancer after radical prostatectomy, ductal carcinoma in situ after radical prostatectomy, or other tumor deemed cured by the investigator. 3. Histologically confirmed the presence of small cell lung cancer component. 4. Participants who have received any systemic anti-cancer treatment. 5. Clinically significant cardiovascular or cerebrovascular disease, including: 1. Myocardial infarction or unstable angina within 6 months before first dose 2. Stroke or transient ischaemic attack within 6 months before first dose 3. Uncontrolled hypertension (systolic ≥ 160 mmHg and/or diastolic ≥ 100 mmHg) despite optimal therapy 4. Congestive heart failure (NYHA class III-IV) 5. Myocarditis 6. Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids \>10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy are permitted. 7. Presence of any active autoimmune disease or history of autoimmune disease. 8. Idiopathic pulmonary fibrosis, organizing pneumonia, drug pneumonia, or active pneumonia shown on CT during screening period have been or are currently present. 9. History of allogeneic haematopoietic stem-cell or solid-organ transplantation. 10. The subject has congenital or acquired immune deficiency (such as HIV infected persons). 11. Active hepatitis (HBsAg positive and HBV DNA \>the upper limit of normal value; HCV antibody and HCV RNA positive. Subjects who meet the following criteria may be enrolled: HBV-DNA \<500 IU/mL measured within 28 days prior to study dosing, have received at least 4 weeks of standard antiviral therapy, and are willing to continue antiviral therapy throughout the study period.) 12. Participants who are allergic to the test drug or any auxiliary materials. 13. The vaccine was administered within 30 days before first dose or planned during treatment and up to 90 days after the last dose. 14. Severe active infection within 2 weeks before first dose. 15. Other factors that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.

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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

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

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, China

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