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Report for Clinical Trial NCT03845270

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Trial of Trastuzumab in Combination With Pertuzumab in Pretreated Patients With Non-small Cell Lung Cancer (NSCLC) Harboring a Her2 Mutation and Receiving Docetaxel

HER2 (erbB-2/neu) is a member of the erbB receptor tyrosine kinase family. ERBB2 gene which encodes human epidermal growth factor 2 (HER2) is a major proliferative driver activating downstream signaling through PI3K-AKT and MEK-ERK. HER2 overexpression or gene amplification is associated with sensitivity to trastuzumab and lapatinib in breast cancer. Among actual lung cancer biomarker, HER2 remains apart. HER2 involvement is known for a long time but clinical research has been stopped for many years since the first clinical trials in unselected patients were negative. Recently trastuzumab + pertuzumab + docetaxel has been tested for first-line treatment of HER2-positive metastatic breast cancer (CLEOPATRA trial). Analysis of the primary end point showed that patients who received pertuzumab, trastuzumab, and docetaxel (pertuzumab group) had a significantly longer median progression-free survival, as assessed by independent reviewers an did those who received placebo, trastuzumab, and docetaxel (control group) (hazard ratio favoring the pertuzumab group, 0.62). There is thus a strong rational for treating HER2 mutated lung cancer patient with these drugs.

NCT03845270 Non Small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer Stage III HER2 Gene Mutation
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: pertuzumab + trastuzumab + docetaxel

Description: Cycle 1 : D1 : pertuzumab 840 mg, D2 : trastuzumab 8 mg/kg + docetaxel 75 mg/m² Subsequent cycle : D1 : pertuzumab 420 mg + trastuzumab 6 mg/kg + docetaxel 75 mg/m²
Type: Drug
Group Labels: 1

pertuzumab + trastuzumab + docetaxel


Primary Outcomes

Description: Percentage of patient with confirmed objective response rate with RECIST 1.1

Measure: Objective Response Rate

Time: 6 weeks (confirmation needed at 12 weeks)

Secondary Outcomes

Description: Time from enrollment until death due to any cause

Measure: Overall Survival

Time: About 24 months

Description: time from enrollment to first observation of progression (according to RECIST v1.1) or date of death (from any cause)

Measure: Progression-free survival

Time: About 24 months

Description: Time from documentation of tumor response to disease progression.

Measure: Duration of response

Time: About 24 months

Measure: Incidence, type and severity of non-serious and serious adverse event

Time: About 24 months

Other Outcomes

Measure: Correlation between OR, PFS, and HER2 mutation kinetic on cfDNA

Time: About 24 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 G776C

Not suitable for radiation, inoperable stage III or stage IV 4. HER2 exon 20 mutation or insertion among which: in-frame insertions in exon 20 between codons 775 and 881 including the 12bp insertion with a duplication / insertion of 4 amino acids (YVMA) at codon 775, the 3bp insertion with a complex insertion-substitution G776>VC and point mutations L755S and G776C. --- L755S --- --- G776C ---


2 L755S

Not suitable for radiation, inoperable stage III or stage IV 4. HER2 exon 20 mutation or insertion among which: in-frame insertions in exon 20 between codons 775 and 881 including the 12bp insertion with a duplication / insertion of 4 amino acids (YVMA) at codon 775, the 3bp insertion with a complex insertion-substitution G776>VC and point mutations L755S and G776C. --- L755S ---



HPO Nodes


HPO: