New hope for aggressive lung cancer: drug cocktail plus Low-Dose radiation shows promise
NCT ID NCT06477523
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new combination treatment for people with extensive-stage small cell lung cancer who have not had prior therapy. It combines an experimental immunotherapy (AK104) with standard chemotherapy and low-dose radiation to see if it can better control the cancer. The trial involves 57 adults aged 18-80 and focuses on safety and how long the cancer stays under control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 57 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2027
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 to 80 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 to 80 years old. * Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). * Histologically or cytologically confirmed diagnosis of ES-SCLC per the Veterans Administration Lung Study Group (VALG) staging system. * No prior treatment for ES-SCLC. * Measurable disease, as defined by RECIST v1.1. * Eastern Cooperative Oncology Group performance status ≤ 1. * Life expectancy ≥ 3 months. * Adequate hematologic and end-organ function. * All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment. Exclusion Criteria: * Symptomatic or actively progressing Central nervous system metastases. * Uncontrolled carcinomatous meningitis. * Uncontrolled severe cancer pain * Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (once a month or more frequently). * Uncontrolled or symptomatic hypercalcemia. * History of autoimmune disease. * History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest computed tomography (CT) during screening. * Active Tuberculosis infection. * Significant cardiovascular disease. * Major surgical procedure within 28 days prior to enrollment or anticipation of need for major surgical procedure during the course of the study. * Known additional malignancy that is progressing or requires active treatment. * Active infection requiring systemic therapy * Prior allogenic bone marrow transplantation or solid organ transplant. * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications. * Receipt of live attenuated vaccination within 4 weeks prior to the first dose of study treatment, or plan to receive live attenuated vaccine during the study. * Currently receiving the treatment of hepatitis B virus infection.. * Received approved or under development systematic anti-tumor therapy within 28 days before enrollment * Previously received immune checkpoint agonists (antibodies to CD137 targets) or immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) , immune cell therapy and other treatment of any immune mechanism for tumors * Treatment with systemic immunosuppressive medications within 1 week prior to enrollment.. * Known allergies or intolerant to test drugs or their excipients; or a known history of severe hypersensitivity reactions to other antibodies. * Women who are pregnant (positive pregnancy test before medication) or breastfeeding. * Received chest radiation therapy prior to the first dose.
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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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China West Hospital
Chengdu, Sichuan, 610000, China
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West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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