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Report for Clinical Trial NCT03975114

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Phase 2 Study Comparing Immunotherapy With Chemotherapy in the Treatment of Elderly Patients With Advanced NSCLC (MILES-5)

This is a randomized phase 2 trial aiming to assess the early efficacy of two experimental treatment sequences. Three arms are planned; (i) standard chemotherapy followed at progression by single agent immunotherapy with durvalumab (CT), (ii) experimental single agent immunotherapy with durvalumab followed at progression by chemotherapy, (iii) experimental combination immunotherapy with durvalumab+tremelimumab followed at progression by chemotherapy. The the two experimental strategies will be compared with the standard strategy in terms of 12-month overall survival, time considered informative for the type of treatment and disease

NCT03975114 Carcinoma, Non-Small-Cell Lung
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

3 Interventions

Name: Chemotherapy

Description: Any approved first line chemotherapy regimen at Investigators' choice
Type: Drug
Group Labels: 3

Chemo first Immuno Combination Therapy first Immuno Monotherapy first

Name: Durvalumab

Description: Durvalumab 1500 mg iv Q4w until progressive or unacceptable toxicity or patient's refusal
Type: Drug
Group Labels: 3

Chemo first Immuno Combination Therapy first Immuno Monotherapy first

Name: Tremelimumab

Description: Tremelimumab 75 mg iv Q4w for 4 administrations (4 months)
Type: Drug
Group Labels: 1

Immuno Combination Therapy first


Primary Outcomes

Description: 12-month overall survival is defined as the Kaplan-Meier (K-M) survival probability at 12 months after randomization (Chen 2015).

Measure: 12-month overall survival

Time: 12 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Exclusion Criteria: Cancer related 1. Activating epidermal growth factor receptor mutation (exon19 deletion or exon 21 L858R mutation or other activating/sensitizing mutations). --- L858R ---



HPO Nodes


HPO: