Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for … (NCT04351256) | Clinical Trial Compass
CompletedPhase 2
Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy
Germany51 participantsStarted 2020-05-20
Plain-language summary
This is a randomized, open-label, multicenter, phase II trial investigating the combination of thoracic radiotherapy plus Durvalumab in patients with locally advanced, unresectable NSCLC (stage III) that are unfit for chemotherapy (e.g. due to age and/or frailty).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Fully-informed written consent and locally required authorization (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.
✓. Histologically documented diagnosis of unresectable stage III NSCLC.
✓. Non-feasibility of sequential chemo-/radiotherapy as determined by the site's multi-disciplinary tumor board; if there is no tumor board, then this decision will be made by the investigator in consultation with a radiation oncologist, if the investigator is not a radiation oncologist; or by the investigator in consultation with an oncologist, if the investigator is not an oncologist.
✓. Fulfills at least one of the following criteria:
✓. Must have a life expectancy of at least 12 weeks.
✓. FEV1 ≥ 40%
✓. DLCO or DLCO/VA (Hb-corrected, if available) ≥ 40%
Exclusion criteria
✕. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study.
✕. Participation in another clinical study with an investigational product within 21 days prior to the first dose of the study treatment.
✕. Prior immunotherapy or use of other investigational agents, including prior treatment with an anti-Programmed Death receptor-1 (PD-1),anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T-lymphocyte associated antigen-4 (anti-CTLA-4) antibody, therapeutic cancer vaccines.
What they're measuring
1
Toxicity (pneumonitis)
Timeframe: up to 35 months
2
Objective response
Timeframe: up to 35 months
Trial details
NCT IDNCT04351256
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
✕. History or current radiology suggestive of interstitial lung disease.
✕. Oxygen-dependent medical condition.
✕. Any concurrent chemotherapy, investigational product (IMP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is acceptable.
✕. Prior thoracic radiotherapy within the past 5 years before the first dose of study drug.
✕. Major surgery (as defined by the Investigator) within 4 weeks prior to enrollment into the study; patients must have recovered from effects of any major surgery. Note: Local non-major surgery for palliative intent is acceptable.