SNPMiner Trials by Shray Alag

SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT03050437

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Randomized, Open Label, Phase II Study Comparing Pemetrexed Plus Cisplatin Followed by Pemetrexed Until Progression Versus Pemetrexed Alone Until Progression in Non-small Cell Lung Cancer Patients Who Have Progressed on First Line Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)

It has not been established whether platinum-based doublets is better than single agent chemotherapy in EGFR mutant NSCLC patients who failed first-line EGFR TKI. In this prospective trial, the investigators try to evaluate whether the progression-free survival of pemetrexed/cisplatin (PC) regimen is longer than that of pemetrexed single(P) regimen in NSCLC patients who have progressed after first line treatment of EGFR-TKI.

NCT03050437 Carcinoma, Non-Small-Cell Lung
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

2 Interventions

Name: Cisplatin

Description: cisplatin is added to Pem/cis arm

Type: Drug


Name: Pemetrexed

Description: Pem is applied to both arms

Type: Drug

Pem/Cis Pem alone

Primary Outcomes

Measure: progression-free survival

Time: 2 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 L858R

Inclusion Criteria: - Histologically confirmed nonsquamous NSCLC with activating EGFR mutation (on exon 19 deletion or exon 21 L858R mutation) - Stage IIIb, IV or recurrent NSCLC (AJCC 7th criteria) - Age ≥ 20 years - ECOG performance status of 0 or 1 - At least one measurable lesion by RECIST 1.1 - Progression after first line treatment with EGFR TKIs for advanced NSCLC - Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery - At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy - Adequate renal function: estimated creatinine clearance ≥ 45 mL/min - Organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 3 UNL, in case of known hepatic metastasis, AST/ALT< 5 UNL - Written informed consent form - No other previous systemic chemotherapy Exclusion Criteria: - Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia - Patients with post-obstructive pneumonia or uncontrolled serious infection - Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method) - Uncontrolled symptomatic brain metastasis - Presence of third space fluid which cannot be controlled by drainage - Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer. --- L858R ---

HPO Nodes

Non-small cell lung carcinoma
Genes 2