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Report for Clinical Trial NCT03381274

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects With Previously Treated Advanced EGFRm NSCLC

The objective of this study is to investigate the safety, tolerability and antitumor activity of novel combination therapies administered in subjects with advanced EGFRm NSCLC

NCT03381274 Carcinoma, Non-Small-Cell Lung
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

3 Interventions

Name: MEDI9447

Description: Subjects will receive MEDI9447 in combination with osimertinib or AZD4635 until disease progression
Type: Biological
Group Labels: 2

Arm A Arm B

Name: Osimertinib

Description: Subjects will receive osimertinib in combination with MEDI9447 until disease progression
Type: Drug
Group Labels: 1

Arm A

Name: AZD4635

Description: Subjects will receive AZD4635 in combination with MEDI9447 until disease progression
Type: Drug
Group Labels: 1

Arm B


Primary Outcomes

Description: The primary endpoint is safety as assessed by the presence of adverse events and serious adverse events

Measure: Incidence of Adverse Events as a measure of safety

Time: Screening through 90 days after last dose of investigational product

Description: The primary endpoint in dose expansion phase includes efficacy assessed by objective response

Measure: Objective response rate as a measure of anti tumor activity in dose expansion phase

Time: During treatment through study completion, about 2 years after the last subject dosed

Secondary Outcomes

Description: The duration from the first documentation of objective response (OR) to the first documented disease progression or death due to any cause, whichever occurs first

Measure: Duration of Response (DoR)

Time: During treatment through study completion, about 2 years after the last subject dosed

Description: Defined as complete response (CR), partial response (PR) or stable disease (SD)

Measure: Disease Control (DC)

Time: During treatment through study completion, about 2 years after the last subject dosed

Description: From the start of treatment with investigational product until the first documentation of disease progression or death due to any cause, whichever occurs first.

Measure: Progression Free Survival (PFS)

Time: During treatment through study completion, about 2 years after the last subject dosed

Description: From the start of treatment with investigational product until death due to any cause

Measure: Overall Survival (OS)

Time: During treatment through study completion, about 2 years after the last subject dosed

Description: Defined as best overall response of confirmed CR or confirmed PR according to RECIST version 1.1

Measure: Objective Response by T790M status

Time: During treatment through study completion, about 2 years after the last subject dosed

Description: Defined as CR, PR or SD

Measure: Disease Control by T790M status

Time: During treatment through study completion, about 2 years after the last subject dosed

Description: Pharmacokinetic

Measure: Serum MEDI9447 concentration levels

Time: During treatment through 90 days after last dose of investigational product

Description: Pharmacokinetic

Measure: Serum Osimertinib concentration levels

Time: During treatment through 90 days after last dose of investigational product

Description: Pharmacokinetic

Measure: Serum AZD4635 concentration levels

Time: During treatment through 90 days after last dose of investigational product

Description: Immunogenicity

Measure: Development of detectable anti-drug antibody(ADA) to MEDI9447

Time: During treatment through 90 days after last dose of investigational product

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

Objective Response by T790M status. --- T790M ---

Disease Control by T790M status. --- T790M ---

Inclusion Criteria: 1. Age ≥ 18 2. ECOG Performance Status of 0 or 1 3. Weight ≥ 35 kg 4. Diagnosed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFR mutation - For Arm A: must have received 1 prior line of therapy with an EGFR TKI and confirmed T790M negative - For Arm B: must have received at least 2 but not more than 4 prior lines of therapy. --- T790M ---

Additional Exclusion Criteria for Arm B 1. Herbal preparations/medications are not allowed throughout the study 2. History of seizures excluding those that occurred due to previously untreated CNS metastasis Inclusion Criteria: 1. Age ≥ 18 2. ECOG Performance Status of 0 or 1 3. Weight ≥ 35 kg 4. Diagnosed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFR mutation - For Arm A: must have received 1 prior line of therapy with an EGFR TKI and confirmed T790M negative - For Arm B: must have received at least 2 but not more than 4 prior lines of therapy. --- T790M ---



HPO Nodes


HPO: