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New combo therapy for advanced lung cancer tested in Real-World study

NCT ID NCT07247227

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a combination of the immunotherapy drug Sugemalimab and standard chemotherapy as a first treatment for people with advanced non-small cell lung cancer (NSCLC) that has spread. The goal is to see how well this combo works in real-world clinics, not just in controlled trials. About 150 participants will receive the treatment, and researchers will track how long they live without the cancer getting worse, overall survival, and side effects.

What this could mean

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

Active substance
Sugemalimab (an immunotherapy drug) plus platinum-based chemotherapy
What this could lead to
If successful, this could show that Sugemalimab plus chemo works well in everyday clinical practice for advanced lung cancer, potentially improving survival and treatment options.
What could go wrong
This is an early, single-arm study without a comparison group, so results may not be definitive. Side effects from immunotherapy and chemo can be serious, and the real-world setting may introduce variability.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

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

Started

Oct 2023

Expected to finish

May 2027

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. Age ≥ 18 years. 2. Patients voluntarily join the study and sign an informed consent form for the study. 3. ECOG PS score 0-3 (patients with PS score 2-3 would be enrolled if due to the tumor disease and anticipated to be improved at investigators' decision). 4. Histologically documented, stage III, IV non-Small Cell Lung Cancer (according to version 8th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated systematically(excluding local therapy for local lesions or symptomatic relief, palliative radiotherapy, intervention, intrathecal injection, nerve block, etc.). 5. Patients with stage III NSCLC who are not suitable for surgery at a multidisciplinary discussion or investigators' assessment. 6. Patients with at least one measurable target lesion by CT scan/MRI (RECISTv1.1). 7. Patients with active brain metastases and liver metastases could be enrolled (Concurrent radiotherapy, intervention, dehydration, and other local treatment are permitted). 8. Interstitial pneumonia, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or active pneumonia with clinical symptoms of grade 2, can be included after symptomatic treatment until recovery to grade 0-1. 9. Fertile men and women of childbearing age must agree to take effective contraceptive measures from signing the main informed consent until 180 days after the last dose of the study drug. Women of childbearing potential include premenopausal women and women within 2 years of menopause. Females of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of study drug. Exclusion Criteria: 1. All patients carry activating mutations of EGFR, ALK, ROS1, and RET. (No more mutation test needed). 2. Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer). 3. Histopathologically or cytopathologically confirmed non-NSCLC. 4. Any prior treatment of antibody/drug that targets T-cell coregulatory proteins (not limited to CTLA-4 inhibitors or other agents targeting T cells). 5. Any tumor history within the past 5 years prior to the start of treatment in this study (except cured cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors with surgical resection alone and at least 5 consecutive years of disease-free survival). 6. Patients with active, unstable systemic disease, active infection, uncontrolled hypertension, heart failure (NYHA class \>= II), unstable angina pectoris, acute coronary syndrome, severe arrhythmia, severe liver, kidney, or metabolic diseases, HIV infection. 7. Pregnant or lactating women. 8. Systemic anti-tumor therapy planned within 4 weeks before first-line treatment or during medication after enrollment, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (with the exception of thymosin, lentinan, and other immunomodulator therapy). 9. Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before 1st line therapy. 10. Participation in other anti-tumor drug clinical trials within 4 weeks before first-line therapy. 11. Active, known, or suspected autoimmune diseases. Vitiligo and Type I diabetes mellitus with no systemic treatment are allowed. Residual hypothyroidism caused by autoimmune thyroiditis requiring only hormone replacement therapy is allowed. 12. With known mental illness, alcoholism, drug abuse, or other factors which may cause termination of this study, affect the safety of subjects, or collection of data and samples.

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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

  • cancer hospital, Chinese Academy of medical sciences and Peking union medical college

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

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