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Report for Clinical Trial NCT03091491

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Randomised Phase 2 Study of Nivolumab Versus Nivolumab and Ipilimumab Combination in EGFR Mutant Non-small Cell Lung Cancer

The purpose of this study is to determine whether Nivolumab in combination with Ipilimumab is associated with superior response rate compared to Nivolumab alone in patients with advanced Epidermal Growth Factor Receptor (EGFR) mutation positive Non-small Cell Lung Cancer who have failed one line of standard EGFR tyrosine kinase inhibitor and not more than one line of chemotherapy regimen. This study also aims to determine predictive biomarkers of response/benefit in patients with EGFR mutation positive NSCLC.

NCT03091491 Non-Small Cell Lung Cancer
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 administered every 6 weeks as a 30 min IV infusion

Type: Drug

Nivolumab and Ipilimumab

Name: Nivolumab

Description: Nivolumab 3 mg/kg administered every 2 weeks as a 30 min IV infusion

Type: Drug

Nivolumab Nivolumab and Ipilimumab


Primary Outcomes

Measure: Overall Response Rate

Time: From baseline until best overall response of Complete Response (CR) or Partial Response (PR), up to 2 years

Secondary Outcomes

Measure: Progression-Free Survival

Time: From time of randomisation until first documented disease progression or death due to any cause, up to 2 years

Measure: Duration of Response

Time: From time of first response until first documented disease progression or death due to any cause, up to 2 years

Measure: Overall Survival

Time: From time of randomisation until death due to any cause, up to 2 years

Description: Safety data of all adverse events and serious adverse events, will be graded according to the NCI CTCAE v 4.0.

Measure: Evaluate the toxicity profiles of Nivolumab with or without Ipilimumab by measuring the number of participants with treatment-related adverse events

Time: From the time the Informed Consent Form is signed until at least 100 days after discontinuation of dosing, up to 2 years

Measure: Evaluate capability of the addition of Ipilimumab to patients who progress on Nivolumab alone (Arm A) to achieve clinical benefit by measuring the time taken to achieve CR, PR or Stable Disease (SD)

Time: From time of first dose of Ipilimumab until best overall response of CR, PR, or SD, up to 2 years

Description: Biomarkers: PD-L1, mutational burden, microsatellite instability, blood-based biomarkers

Measure: Evaluate an array of biomarkers in predicting response to Nivolumab and/or Ipilimumab

Time: From time of first dose of study treatment until clear-cut disease progression, up to 2 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

Eastern Cooperative Oncology Group (ECOG) 0-2 performance status v. Progressed on one line of standard EGFR TKI and not more than one line of chemotherapy; 3rd generation EGFR TKI for patients with T790M mutation is allowed - A 14-day washout period is required for EGFR TKI for patients who received this as the last therapy before recruitment - A 28-day washout period is required for chemotherapy for patients who received this as the last therapy before recruitment. --- T790M ---

The use of 3rd generation EGFR TKI for patients with acquired mutation that substitute a threonine (T) with a methionine (M) at position 790 of exon 20 (T790M) is allowed. --- T790M ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1