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Lung cancer trial aims to boost tumor shrinkage while protecting lungs

NCT ID NCT07418866

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a new approach for advanced non-small cell lung cancer. It combines chemotherapy and immunotherapy with a special 'high-low mixed-dose' radiotherapy that gives a strong dose to large tumors and a lower dose to smaller ones. The goal is to shrink tumors faster and reduce lung damage. The study will enroll 70 people with advanced lung cancer that does not have certain genetic mutations.

What this could mean

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

Active substance
Paclitaxel, Cisplatin, 5-FU, Serplulimab (chemo-immunotherapy drugs) plus high-low mixed-dose radiotherapy
What this could lead to
If successful, this approach could improve tumor shrinkage and disease control in advanced lung cancer while reducing the risk of radiation-related lung inflammation.
What could go wrong
This is an early phase 2 trial with only 70 participants, so results may not apply broadly. The combination of treatments may still cause side effects like lung inflammation or other toxicities.

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 70 people

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

Expected to start

Feb 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 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: * Signed written informed consent obtained prior to the initiation of any trial-related procedures. * Age \> 18 years. * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). * Negative for driver gene mutations (EGFR, ALK, ROS1, RET, MET exon 14 skipping, HER2, BRAF, KRAS G12C). * Locally advanced disease, including Stage III and selected Stage IV (where all lesions are deemed safely treatable with a radiotherapy dose \> 50 Gy in 10 fractions, as assessed by a senior radiation oncologist). * At least one thoracic lesion with a short-axis diameter \> 2 cm. * Positive hilar or mediastinal lymph nodes. * ECOG Performance Status of 0 or 1. * Life expectancy \> 3 months. * Adequate organ function, as defined by the following laboratory parameters: 1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L. 2. Platelet count ≥ 100 × 10⁹/L. 3. Hemoglobin \> 9 g/dL. 4. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN). 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. 6. Serum creatinine ≤ 1.5 × ULN AND calculated creatinine clearance (using the Cockcroft-Gault formula) ≥ 60 mL/min. 7. Adequate coagulation, defined as an International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN. 8. Normal thyroid function, defined as Thyroid-Stimulating Hormone (TSH) within normal limits. Subjects with baseline TSH outside the normal range may be enrolled if both total T3 (or free T3) and free T4 levels are within normal limits. 9. Cardiac enzymes within normal limits (subjects may be enrolled if the investigator judges isolated laboratory abnormalities to be clinically insignificant). * For female subjects of childbearing potential, a negative urine or serum pregnancy test must be documented within 3 days prior to receiving the first dose of study medication (Cycle 1, Day 1). If a urine pregnancy test result is ambiguous or cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential is defined as being postmenopausal for at least 1 year, surgically sterile, or having undergone a hysterectomy. * Subjects (both male and female) at risk of pregnancy must agree to use highly effective contraception (with a failure rate of \<1% per year) throughout the treatment period and for 120 days after the last dose of study medication (or 180 days after the last dose of chemotherapy), whichever is later. Exclusion Criteria: * Patients with severe emphysema, interstitial lung changes, or COPD; * Resting blood oxygen saturation \< 93%; * History of other malignancies requiring chemotherapy within the past 2 years; * History of thoracic radiotherapy; * Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatment; * Current use of systemic corticosteroids (\>10 mg daily prednisone or equivalent) or any form of immunosuppressive therapy within 7 days prior to the first study dose (excluding topical, nasal, inhaled, or local corticosteroids); \*Note: Physiological corticosteroid doses (≤10 mg/day prednisone or equivalent) are permitted.\* * Known history of allogeneic organ transplantation (except corneal transplant) or allogeneic hematopoietic stem cell transplantation; * Known allergy to any component of the study drug or its excipients; * Known history of HIV infection (positive HIV1/2 antibodies); * Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA above the upper limit of normal at the local laboratory); Note: Hepatitis B subjects meeting the following criteria may be enrolled: a) HBV DNA \< 1000 copies/mL (200 IU/mL) before the first dose, with ongoing antiviral therapy throughout chemotherapy to prevent reactivation; b) Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV DNA (-) do not require prophylactic antiviral therapy but require close monitoring for reactivation. * Active HCV infection (positive HCV antibody with detectable HCV-RNA above the lower limit of detection); * Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1); Note: Inactivated seasonal influenza vaccines are permitted within 30 days prior to the first dose; live attenuated intranasal influenza vaccines are not allowed. * Pregnant or breastfeeding women; * Any severe or uncontrolled systemic disease, including but not limited to: 1. Resting ECG showing clinically significant uncontrolled abnormalities in rhythm, conduction, or morphology (e.g., complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation); 2. Unstable angina, congestive heart failure, or chronic heart failure classified as NYHA Class ≥2; 3. Arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment (e.g., myocardial infarction, unstable angina, stroke, or transient ischemic attack); 4. Poorly controlled hypertension (systolic BP \>140 mmHg or diastolic BP \>90 mmHg); 5. History of non-infectious pneumonitis requiring corticosteroids within 1 year prior to the first dose, or current clinically active interstitial lung disease; 6. Active tuberculosis; 7. Active or uncontrolled infection requiring systemic therapy; 8. Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; 9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10. Poorly controlled diabetes (fasting blood glucose \>10 mmol/L); 11. Urine dipstick showing protein ≥++ with confirmed 24-hour urine protein \>1.0 g; 12. Psychiatric disorders that may interfere with treatment compliance; * Any other condition (e.g., medical history, disease, ongoing treatment, or laboratory abnormality) that may interfere with study results, compromise patient participation, or pose additional risks-in the investigator's judgment-making the subject unsuitable for study enrollment.

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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 official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

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