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Locally Advanced Disease / Non Small Cell Lung Cancer / Everolimus · Phase 1 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 1 dose-escalation trial registering the safety and tolerability of everolimus combined with radiotherapy and subsequent chemotherapy in locally advanced non-small-cell lung cancer. No results are posted in this registry record; the record documents only the study protocol and design.
Phase 1, Interventional, Non Randomized, Single Group, Open label, Treatment purpose. Non-small Cell Lung Cancer, Locally Advanced Disease; age from 18 Years. Intervention: Everolimus. n = 26. 1 site: France.
This is a completed Phase 1 dose-escalation trial registering the safety and tolerability of everolimus combined with radiotherapy and subsequent chemotherapy in locally advanced non-small-cell lung cancer. No results are posted in this registry record; the record documents only the study protocol and design.
No results reported in this registry record; primary outcome toxicity data at eleven weeks not posted. Phase 1 design: dose-escalation study meant to establish tolerability, not efficacy; no efficacy endpoints mentioned.
This is a registry record of a completed Phase 1 trial. No results are posted; clinicians should not assume any safety or efficacy conclusions from this registration alone. Efficacy and definitive safety data from published results would be needed to guide practice.
Phase 1 safety study with completed enrollment of 26 participants examining everolimus dosing in combination with radiotherapy; no results posted in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This is a registry record of a completed Phase 1 trial. No results are posted; clinicians should not assume any safety or efficacy conclusions from this registration alone. Efficacy and definitive safety data from published results would be needed to guide practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT01167530). This is a study registration, not published results. Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 26 participants (ACTUAL). Conditions: Non-small Cell Lung Cancer, Locally Advanced Disease. Interventions: DRUG: Everolimus. Primary outcome measures: Toxicity , Eleven week. Brief summary: The phase 1 study evaluats RAD001 in combination with radiotherapy in non-small cell lung cancer. First phase of the study:RAD001 (everolimus) will be administered per os every Monday, one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of the radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 10, 20 and 50 mg of RAD001 per week.Second phase of the study:RAD001 (everolimus) will be administered per os every day one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 2.5, 5 and 10 mg of RAD001 per day.The two phases of the study may be conducted independently and in parallel.Radiotherapy: 66 Grays over 6.5 weeks. (5 weekly fractions of 2 Grays)Chemotherapy: 2 cycles: Cisplatin 100 mg/m2 D1, Navelbine 25 mg/m2 D1, D8, every 21 days.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.