New radiation combo aims to boost immunotherapy in advanced lung cancer
NCT ID NCT05615142
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether adding low-dose radiation and targeted radiation (SBRT) to an immunotherapy drug (PD-1 inhibitor) is safe for people with stage IV non-small cell lung cancer who have not responded to standard treatments. About 9 participants will receive the combination therapy to check for side effects and see if it helps control the cancer. The goal is to find a tolerable way to potentially improve treatment outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Be willing and able to provide written informed consent/assent for the trial. 2. Be ≥18 years of age on day of signing informed consent. 3. Patients with histologically or cytologically confirmed stage IV NSCLC. 4. Be willing to undergo repeat biopsy of tumor lesions according to the study protocol. 5. Patients who have failed the standard therapy, or who are unsuitable for standard treatment, or refuse chemotherapy. 6. At least one measurable lesion according to RECIST 1.1. A lesion that has previously received radiotherapy can be considered a target lesion only if this lesion is clearly progressed after radiotherapy. 7. The target lesions (irradiated lesions) are \> 5cm in in diameter 8. ECOG 0-2. 9. Life expectancy of \> 3 months. 10. Patients must have normal organ and bone marrow function as defined below: Total bilirubin \</= 1.5 x upper limit of normal (ULN). Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase (SGOT)/ Alanine Aminotransferase (ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) \<2.5 X institutional upper limit of normal (\</= 5 X institutional ULN for subjects with liver metastases) \*WBC \>/= 3500/uL, ANC \>/= 1500/uL \*Platelets \>/= 90K/ul \*Hemoglobin \>/= 9g/dL \*Creatinine \</= 1.5 x ULN, or creatinine clearance ≥ 50 ml/min(Cockcroft-Gault equation). Coagulation: International Normalized Ratio (INR)≤ 1.5 × ULN, Partial thromboplastin time (PTT) ≤1.5 × ULN; left ventricular ejection fraction (LVEF) \>/= 50% and QTcF (Fridericia's formula) ≤ 450ms 11. Patients has recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. 12. Wash out period for chemotherapy is more than ≥ 4 weeks, for targeted small molecule therapy ≥ 5 half-lives; palliative radiotherapy must have been completed for at least ≥ 2 weeks, chest radiotherapy must have been completed for at least ≥ 4 weeks, and major surgery must have been completed for ≥ 4 weeks. 13. Subjects with no severe pulmonary ventilation dysfunction, no acute heart failure, and no contraindication to radiotherapy as judged by the radiotherapist. Subjects who agree to receive immunotherapy and radiotherapy treatment. 14. Subjects should agree to use an adequate method of contraception. Exclusion Criteria: 1. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or spinal cord compression, etc. 2. With oncologic emergencies that require immediate treatment 3. EGFR/ALK/ROS-1 mutation or mutation status unknown. 4. Has evidence of interstitial lung disease or active and/or non-infectious pneumonitis (drug-induced pneumonia, radiation-induced pneumonia, etc.) requiring steroid therapy. 5. History of pulmonary fibrosis, pulmonary hypertension, severe irreversible airway obstruction disease 6. Patients with peripheral neuropathy. 7. Significant heart disease or impairment of cardiac function 8. Fluid accumulating in the third space, such as pericardial effusion, pleural effusion and peritoneal effusion that remains uncontrolled by aspiration or other treatment 9. Known allergy to drugs or excipients, known severe allergic reaction to any of the PD-1 monoclonal antibodies 10. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; treatment with oral or intravenous antibiotics within 2 weeks prior to the start of study treatment; patients receiving prophylactic antibiotic therapy (e.g., to prevent urinary tract infection or exacerbation of COPD) are eligible for this study. 11. Known or suspected active autoimmune disease (congenital or acquired) such as uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (patients with vitiligo, or resolved childhood asthma may be enrolled; patients with type I diabetes with good insulin control may also be enrolled) 12. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
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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.
Contacts and locations
Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
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Other studies related to the condition(s) this trial covers.
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