drugset / Trial / NCT05255302
De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction
RandomizedParallel-groupOpen-labelTreatment
Summary
Immunotherapeutic approaches recently have demonstrated clinical efficacy in several cancer types, including melanoma and NSCLC. As a matter of fact, first registration trials of immune-checkpoints inhibitors (ICI) in second-line settings (pembrolizumab as well as nivolumab or atezolizumab) had stated that ICI could be continued until disease progression or not tolerable toxicity, up to 5 years. This is only for the first-line registration studies that the arbitrary maximal duration of treatment of 2 years was set up by the Companies sponsoring such trials. The aim is to study a de-escalation scheme of treatment from 2 years of immunotherapy to 6 months (27-weeks), in patients with controlled disease.
Timeline
- Start
- 2022-05-02
- Primary completion
- 2025-05
- Completion
- 2029-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | — |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Carboplatin | Small molecule | 6 unknown | — |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | — |