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Can a pill plus immunotherapy and targeted radiation shrink lung tumors before surgery?

NCT ID NCT07754812

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial is testing whether giving a combination of oral paclitaxel (a chemotherapy pill), an immunotherapy drug, and focused radiation before surgery can help older adults with stage IIA-IIIB non-small cell lung cancer. The goal is to see if this pre-surgery treatment can shrink or eliminate tumors, making surgery more effective. The study includes people aged 70 and older who are eligible for surgery and do not have certain genetic mutations. Researchers will measure how well the tumors respond and monitor for 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
oral paclitaxel solution combined with an immune checkpoint inhibitor (PD-1/PD-L1 inhibitor) and stereotactic body radiotherapy
What this could lead to
If successful, this approach could shrink tumors before surgery in older lung cancer patients, potentially improving surgical outcomes and long-term control.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not hold in larger groups. The combination may cause significant side effects, especially in older adults.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 78 people

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

Started

Jun 2026

Expected to finish

Oct 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

70 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: * Age 70 years or older, regardless of sex. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically confirmed non-small cell lung cancer, clinical stage IIA-IIIB according to the 8th edition of the AJCC staging system. * No evidence of distant metastasis and considered suitable for radical lung cancer surgery. * The primary lung lesion is suitable for stereotactic body radiotherapy. * No sensitizing driver alterations in EGFR, ALK, ROS1, or other tested actionable genes. * Adequate major organ function, including all of the following: * Absolute neutrophil count at least 1.5 × 10\^9/L, platelet count at least 100 × 10\^9/L, and hemoglobin at least 9 g/dL. * Total bilirubin no more than 1.5 × the upper limit of normal; alanine aminotransferase and aspartate aminotransferase no more than 2.5 × the upper limit of normal. * Serum creatinine no more than 1.5 × the upper limit of normal or creatinine clearance at least 60 mL/min. * Urine protein less than 1+; if urine protein is 1+, 24-hour urine protein must be less than 500 mg. * Blood glucose within the normal range or stable glycemic control in participants with diabetes. * Baseline forced expiratory volume in 1 second (FEV1) at least 2 L; if FEV1 is less than 2 L, the predicted postoperative FEV1 must be greater than 800 mL as assessed by a thoracic surgeon. * No myocardial infarction within the previous year, no unstable angina, no symptomatic severe arrhythmia, and no cardiac insufficiency. * The participant has been fully informed and voluntarily provides written informed consent. Exclusion Criteria: * Prior lobectomy, thoracic radiotherapy, or systemic antitumor therapy. * Another concurrent malignancy or a history of another malignancy cured less than 5 years before enrollment, except adequately treated cervical carcinoma in situ or basal cell or squamous cell carcinoma of the skin. * Active autoimmune disease or a history of autoimmune disease requiring systemic immunosuppressive treatment. * Active infection requiring systemic treatment, active tuberculosis, human immunodeficiency virus infection, active hepatitis B or hepatitis C, active syphilis, or another active transmissible infection specified by the protocol. * Severe cardiac, hepatic, renal, or metabolic disease that precludes surgery or study treatment. * History of interstitial lung disease or drug-induced pneumonitis, or imaging evidence of active interstitial lung disease. * Uncontrolled large pleural effusion or pericardial effusion. * Major surgery, severe trauma, or treatment with another investigational drug within 4 weeks before enrollment. * Recent receipt of an anticancer vaccine or live vaccine. * Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study or may interfere with interpretation of the study results.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma Pathologic Complete Response

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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Guangdong Provincial People's Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 519041, China

  • Lishui People's Hospital

    NOT_YET_RECRUITING

    Lishui, Zhejiang, 323000, China

    Contact Email: •••••@•••••

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • The Affiliated Suqian Hospital of Xuzhou Medical University

    NOT_YET_RECRUITING

    Suqian, Jiangsu, 223800, China

  • Zhejiang Cancer Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310022, China

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