SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03469960

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Randomized Phase 3 Trial Comparing Continuation Nivolumab-Ipilimumab Doublet Immunotherapy Until Progression Versus Observation in Treatment-naive Patients With PDL1-positive Stage IV Non-Small Cell Lung Cancer (NSCLC) After Nivolumab-Ipilimumab Induction Treatment

Non Small Cell lung cancer (NSCLC) remains the first cause of death by cancer in the World. For the patients presenting a NSCLC stage IV, the median of survival is about 15 months today. The chemotherapy with platinum is the standard treatment for these patients but immunotherapy showed these efficacy in 1st line for patients PD-L1 positive. On the other hand, the duration of treatment by immunotherapy is not clear. Indeed, prolonged responses and long survivals have been described in patients having interrupted the treatment. In the melanoma, a treatment of 6 months of ipilimumab demonstrated its efficacy. The objective of the study is to demonstrate that a treatment of 6 months followed by an observation (stop and go) is not less effective than a treatment given until progression or toxicity. This strategy would allow to decrease the accumulated toxicities, to improve the quality of life of the patients and to decrease the costs.

NCT03469960 Non-Small Cell Lung Cancer Metastatic
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Ipilimumab

Description: Ipilimumab 1 mg/kg every 6 weeks

Type: Drug

Arm A : standard treatment Arm B : experimental arm

Name: Nivolumab

Description: Nivolumab 3 mg/kg every 2 weeks

Type: Drug

Arm A : standard treatment Arm B : experimental arm


Primary Outcomes

Description: Time between the date of randomization and the first date of documented progression, as determined by BICR (Blinded Independent Central Review), or death due to any cause, whichever occurs first.

Measure: Progression Free Survival (PFS1)

Time: 24 months after randomization of the last subject

Secondary Outcomes

Description: Time between the start date of the second line and the second date of documented progression, as determined by BICR, or death due to any cause, whichever occurs first.

Measure: Progression Free Survival (PFS2)

Time: 24 months after randomization of the last subject

Description: Time until definitive deterioration (TUDD) from the randomization time in the experimental arm B.

Measure: Quality of life

Time: 24 months after randomization of the last subject

Measure: Overall survival (OS)

Time: 6, 12 and 18 months after randomization

Description: PD-L1-stained % of tumor cells will be associated to the rate of disease control patients at 6 months, PFS1, PFS2 and OS

Measure: Biological correlative exploratory studies (PD-L1)

Time: 6 months

Description: PD-L1 H-score will be associated to the rate of disease control patients at 6 months, PFS1, PFS2 and OS

Measure: Biological correlative exploratory studies (PD-L1 H score)

Time: 6 months

Description: CD3/CD8 tumor infiltration will be associated to the rate of disease control patients at 6 months, PFS1, PFS2 and OS

Measure: Biological correlative exploratory studies (CD3/CD8)

Time: 6 months

Description: neutrophil tumor infiltration will be associated to the rate of disease control patients at 6 months, PFS1, PFS2 and OS

Measure: Biological correlative exploratory studies (neutrophil)

Time: 6 months

Description: plasma concentration of different cytokines at baseline or at the randomization point, will be associated to the rate of disease control patients at 6 months, PFS1, PFS2 and OS

Measure: Biological correlative exploratory studies (cytokines)

Time: 6 months

Description: plasma concentration of different chemokines at baseline or at the randomization point, will be associated to the rate of disease control patients at 6 months, PFS1, PFS2 and OS

Measure: Biological correlative exploratory studies (chemokines)

Time: 6 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 G719A

Exclusion Criteria: 1. Small cell lung cancer or tumors with mixt histology including a SCLC component 2. Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R ou L861X mutations in exon 21, G719A/S mutation in exon 18) or HER exon 20 insertion (either tissue or plasma cfDNA mutation). --- L858R --- --- G719A ---


2 L858R

Exclusion Criteria: 1. Small cell lung cancer or tumors with mixt histology including a SCLC component 2. Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R ou L861X mutations in exon 21, G719A/S mutation in exon 18) or HER exon 20 insertion (either tissue or plasma cfDNA mutation). --- L858R ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1