The Selective Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer Tr… (NCT07146230) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The Selective Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer Trial 2
United States52 participantsStarted 2026-05
Plain-language summary
This is a randomized trial evaluating the efficacy and safety of sequential dual-agent immunotherapy and risk-adapted radiotherapy for patients with locally advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score of at least 50%. Participants will be randomized between two dual-agent immunotherapy regimens: durvalumab + monalizumab versus durvalumab + oleclumab.
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 (e.g., Health Insurance Portability and Accountability Act) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
✓. Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations, including follow-up.
✓. Age \> 18 years at time of study entry
✓. Body weight ≥35 kg
✓. Life expectancy of at least 12 weeks
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Previously untreated, pathologically proven NSCLC and one of the following stages:
✓. American Joint Committee on Cancer (AJCC) version 8 Stage II disease, medically or technically unresectable
Exclusion criteria
✕. Participation in another clinical study with an investigational product during the last 3 months
✕. 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
✕
What they're measuring
1
Response rate observed using FDG-PET imaging
Timeframe: Following completion of two cycles of induction dual-agent immunotherapy; approximately 9 weeks
. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy, with these exceptions:
✕. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
✕. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment on this study may be included after consultation with the Study Physician.
✕. Any concurrent chemotherapy, Intraperitoneal (IP) chemotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
✕. History of another primary malignancy except for
✕. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence