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Report for Clinical Trial NCT03333343

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase Ib, Open Label, Multi-center Study to Characterize the Safety, Tolerability and Preliminary Efficacy of EGF816 in Combination With Selected Targeted Agents in EGFR Mutant NSCLC

The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients with advanced EGFR-mutant NSCLC.

NCT03333343 EGFR-mutant Non-small Cell Lung Cancer
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

6 Interventions

Name: EGF816

Description: Study Drug
Type: Drug
Group Labels: 10

Arm 1 Arm 2 Arm 3 Arm A Arm B Arm C Arm D Arm E Arm F Arm G

Name: trametinib

Description: Study Drug
Type: Drug
Group Labels: 2

Arm 1 Arm B

Name: ribociclib

Description: Study Drug
Type: Drug
Group Labels: 2

Arm 2 Arm C

Name: LXH254

Description: Study Drug
Type: Drug
Group Labels: 3

Arm 3 Arm D Arm E

Name: INC280

Description: Study Drug
Type: Drug
Group Labels: 2

Arm A Arm G

Name: gefitinib

Description: Study Drug
Type: Drug
Group Labels: 1

Arm F


Primary Outcomes

Description: Assess safety and tolerability including incidence of dose limiting toxicities, adverse events, and serious adverse events.

Measure: Number of patients with adverse events and serious adverse events

Time: Every day until study end, approximately 4 years

Description: Modified objective response rate (ORR2) per RECIST v1.1 (taking as baseline the most recent assessment prior to initiating combination)

Measure: ORR2

Time: Every 8-12 weeks until study ends, approximately 4 years

Secondary Outcomes

Description: Overall response rate (ORR) per RECIST v1.1

Measure: ORR

Time: Every 8-12 weeks until study ends, approximately 4 years

Description: Time from the date of first dose of study treatment to the date of first documented disease progression (per RECIST v1.1) or death due to any cause

Measure: PFS

Time: Every 8-12 weeks until study ends, approximately 4 years

Description: Proportion of patients with best overall response of CR, PR, or SD

Measure: DCR

Time: Every 8-12 weeks until study ends, approximately 4 years

Description: Time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause

Measure: DOR

Time: Every 8-12 weeks until study ends, approximately 4 years

Measure: Time to response

Time: Every 8-12 weeks until study ends, approximately 4 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 L858R

Inclusion Criteria: - Patients must have histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC. --- L858R ---

- Requirements of EGFR mutation status and prior lines of treatment: - Treatment naive patients, who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation (e.g., L858R and/or ex19del), have not received any systemic antineoplastic therapy for advanced NSCLC and are eligible to receive EGFR TKI treatment. --- L858R ---

- Patients who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation AND an acquired T790M mutation (e.g., L858R and/or ex19del, T790M+) following progression on prior treatment with a 1st-generation EGFR TKI or 2nd-generation EGFR TKI. --- T790M --- --- L858R ---

- Patients who have been treated with systemic anti-neoplastic therapy within: - 2 weeks for fluoropyrimidine monotherapy - 6 weeks for nitrosoureas and mitomycin - 4 weeks or ≤ 5 half-lives (whichever is shorter) for biological therapy (including monoclonal antibodies) and continuous or intermittent small molecule therapeutics or any other investigational agent Inclusion Criteria: - Patients must have histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC. --- L858R ---


2 T790M

- Patients who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation AND an acquired T790M mutation (e.g., L858R and/or ex19del, T790M+) following progression on prior treatment with a 1st-generation EGFR TKI or 2nd-generation EGFR TKI. --- T790M ---

These patients may not have received more than 4 prior lines of antineoplastic therapy in the advanced setting, including EGFR TKI, and may not have received any agent targeting EGFR T790M mutation (i.e., 3rd-generation EGFR TKI). --- T790M ---

- Patients who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation and a "de novo" T790M mutation (i.e., no prior treatment with any agent known to inhibit EGFR including EGFR TKI). --- T790M ---

- Prior therapies: - Patients who have been treated with EGFR TKI in the adjuvant setting within 6 months, unless acquired EGFR T790M is present in a tumor or blood sample obtained since the discontinuation of the EGFR TKI. - Patients who have been treated with prior EGFR TKI targeting T790M (3rd generation). --- T790M ---

- Prior therapies: - Patients who have been treated with EGFR TKI in the adjuvant setting within 6 months, unless acquired EGFR T790M is present in a tumor or blood sample obtained since the discontinuation of the EGFR TKI. - Patients who have been treated with prior EGFR TKI targeting T790M (3rd generation). --- T790M --- --- T790M ---



HPO Nodes


HPO: