Adaptive SBRT Plus Chemoimmunotherapy for ES-SCLC (NCT05403723) | Clinical Trial Compass
SuspendedPhase 1
Adaptive SBRT Plus Chemoimmunotherapy for ES-SCLC
Stopped: PI changed institution. Not yet approved at current location.
United States50 participantsStarted 2026-06-30
Plain-language summary
This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union \[EU\] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
✓. Age \> 18 years at time of study entry
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Body weight \>30 kg
✓. Adequate normal organ and marrow function as defined below:
✓. Hemoglobin ≥10.0 g/dL
✓. Absolute neutrophil count (ANC) ≥1.5 × 109 /L
✓. Platelet count ≥100 × 109/L
Exclusion criteria
✕. Participation in another clinical study with an investigational product during the last 4 weeks prior to first dose of IP
✕. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
✕. Any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
What they're measuring
1
Incidence of treatment-related adverse events (AEs)
✕. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis.
✕. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study PI/Sponsor
✕. Major surgical procedure within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
✕. History of allogenic organ transplantation.
✕. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion: