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Triple threat: new drug and radiation combo takes on lung cancer

NCT ID NCT07271602

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding a special type of radiation (quad shot radiotherapy) to a new immunotherapy drug (QL1706) plus chemotherapy can better control advanced non-small cell lung cancer. About 104 people with stage IV lung cancer that has not been treated yet will take part. The goal is to see if the combination shrinks tumors and delays cancer growth.

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 104 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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: 1. Confirmed age: 18-75 years; 2. Histologically or cytologically diagnosed as lung squamous cell carcinoma or lung adenocarcinoma; 3. Staged as stage IV (T1-4NxM1) according to the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) Cancer Staging System (9th edition), with at least 2 evaluable lesions, including one distant metastatic lesion; 4. Driver gene-negative; 5. ECOG performance status: 0-1; 6. Normal bone marrow function: white blood cell count \> 4×10⁹/L, hemoglobin concentration \> 90 g/L, platelet count \> 100×10⁹/L; 7. Normal liver and kidney function: total bilirubin ≤ 1.5×upper limit of normal (ULN); aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5×ULN; alkaline phosphatase (ALP) ≤ 2.5×ULN; creatinine clearance ≥ 60 mL/min; 8. Normal results of thyroid function, amylase, lipase, pituitary function, inflammatory/infectious markers, myocardial enzymes, and electrocardiogram (ECG). For patients aged \> 50 years with a smoking history, normal pulmonary function test results are required. For patients with abnormal ECG or a history of cardiovascular disease (that does not meet the exclusion criteria listed in item 7), additional myocardial function tests and echocardiography are required, with normal results; 9. Patients have signed the informed consent form and are willing and able to comply with follow-up, treatment, laboratory tests, and other study requirements as specified in the study schedule; 10. Female subjects of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, regularly used contraceptives as prescribed by a physician) from screening until 1 year after treatment. Exclusion Criteria: 1. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus (HBV) DNA quantitation \> 1×10³ copies/mL, or positive for anti-hepatitis C virus (HCV) antibody; 2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS); 3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year, regardless of treatment status, should be excluded. Patients with a history of active tuberculosis more than 1 year ago should be excluded, except those with confirmed regular anti-tuberculosis treatment in the past; 4. Active, known, or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, pituitary disorders, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators). Exceptions include type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia); 5. A history of interstitial lung disease or pneumonia within the past year requiring oral or intravenous steroid treatment; 6. Chronic systemic glucocorticoid therapy (dose equivalent to or exceeding 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects receiving inhaled or topical corticosteroids are eligible; 7. Uncontrolled heart disease, such as: 1) Heart failure with NYHA class ≥ 2; 2) Unstable angina pectoris; 3) History of myocardial infarction within the past year; 4) Supraventricular or ventricular arrhythmias requiring treatment or intervention; 8. Pregnant or lactating women (pregnancy testing should be considered for sexually active women of childbearing age); 9. Previous or current malignant tumors other than adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma; 10. Hypersensitivity to macromolecular protein preparations or any component of QL1706; 11. Active infection within 1 week requiring systemic treatment; 12. Receipt of live vaccines within 30 days prior to the first course of immunotherapy; 13. History of organ transplantation; 14. Other conditions assessed by investigators that may endanger patient safety or compliance, such as severe diseases requiring prompt treatment (including mental illnesses), significantly abnormal test results, or other psychological, family, or social high-risk factors.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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