SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03574753

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase II Study of ABBV-399 in Patients With C-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP SUB-STUDY)

S1400K of Lung-MAP seeks to evaluate the overall response rate with ABBV-399 (Process II) in patients with c-MET positive SCCA. S1400K is a biomarker-driven study for patients with Stage IV or recurrent squamous cell lung cancer, who have c-MET positive squamous cell tumors.

NCT03574753 Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC V7
MeSH: Carcinoma Lung Neoplasms
HPO: Carcinoma Neoplasm of the lung

1 Interventions

Name: ABBV-399

Description: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days

Type: Drug

ABBV-399


Primary Outcomes

Description: Primary analyses will be performed using a more restricted definition of c-Met -positivity criteria. The observation of at least 10 responses will be considered evidence to rule out the null hypothesis of a 15% response rate.

Measure: Response Rate

Time: 11 months

Secondary Outcomes

Description: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.

Measure: Investigator-assessed progression-free survival (IA-PFS)

Time: Up to 3 years

Description: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.

Measure: Overall survival (OS)

Time: Up to 3 years

Description: A design with 91% power and 1-sided 0.05 level type I error would require 40 eligible patients to rule out an objective response rate (ORR) of 15% or less if the true ORR is 35% or greater.

Measure: Overall response rate (ORR)

Time: Up to 3 years

Description: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.

Measure: Duration of response (DoR)

Time: Up to 3 years

Description: With 40 patients, toxicity rates can be estimated within 16% with 95% confidence. Any toxicity with at least 5% prevalence has at least an 87% chance of being observed.

Measure: Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Time: up to 3 years

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 S1400I

Any toxicity with at least 5% prevalence has at least an 87% chance of being observed.. •Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER 5.1 Sub-Study Specific Disease Related Criteria 1. Patients must have been assigned to S1400I. --- S1400I ---

9. Patients who can complete PRO forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I EQ-5D Questionnaire within 14 days prior to registration (see Section 18.2 of S1400I). --- S1400I ---

9. Patients who can complete PRO forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I EQ-5D Questionnaire within 14 days prior to registration (see Section 18.2 of S1400I). --- S1400I --- --- S1400I ---

9. Patients who can complete PRO forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I EQ-5D Questionnaire within 14 days prior to registration (see Section 18.2 of S1400I). --- S1400I --- --- S1400I --- --- S1400I ---

NOTE: Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO study. --- S1400I ---

•Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER 5.1 Sub-Study Specific Disease Related Criteria 1. Patients must have been assigned to S1400I. --- S1400I ---


2 S1400K

Lung-MAP S1400K: c-MET Positive S1400K of Lung-MAP seeks to evaluate the overall response rate with ABBV-399 (Process II) in patients with c-MET positive SCCA. --- S1400K ---

Lung-MAP S1400K: c-MET Positive S1400K of Lung-MAP seeks to evaluate the overall response rate with ABBV-399 (Process II) in patients with c-MET positive SCCA. --- S1400K --- --- S1400K ---

S1400K is a biomarker-driven study for patients with Stage IV or recurrent squamous cell lung cancer, who have c-MET positive squamous cell tumors. --- S1400K ---



HPO Nodes


HPO:
Carcinoma
Genes 11
PTEN CDKN1B APC MLH1 MSH2 FGFR3 KIT DKC1 RSPO1 STK11 NLRP1
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