Combining low-dose radiotherapy with AK104 and chemotherapy for extensive stage small cell lung cancer

Phase 1b/2 Study of AK104 (Anti-PD1/CTLA4 Bispecific Antibody) in Combination With Etoposide and Carboplatin Plus Low-dose Radiotherapy (LDRT) for the First-line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

This study is testing a new treatment that combines low-dose radiation, a drug called AK104, and standard chemotherapy to see if it helps people with extensive stage small cell lung cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 2 sites (Chengdu, Sichuan and 1 other locations)
• Trial ID: NCT06477523 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and efficacy of a new treatment approach that combines low-dose radiotherapy (LDRT) with the drug AK104 and standard chemotherapy agents etoposide and carboplatin/cisplatin for patients with extensive stage small cell lung cancer (ES-SCLC). It is an open-label, multicenter study designed to assess how well this combination works as a first-line treatment. Participants will be monitored for treatment response and safety throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a confirmed diagnosis of extensive stage small cell lung cancer who have not received prior treatment.

Not a fit: Patients with symptomatic central nervous system metastases or uncontrolled cancer-related complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with extensive stage small cell lung cancer.

How similar studies have performed: While this approach is innovative, similar studies combining radiotherapy with immunotherapy and chemotherapy have shown promise in other cancer types, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan and 1 other locations

• China West Hospital — Chengdu, Sichuan, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: YiJun Wu

Conditions SCLC, Extensive Stage