SNPMiner Trials by Shray Alag

SNPMiner SNPMiner Trials (Home Page)

Report for Clinical Trial NCT02488694

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Open-label, Phase II Study of Maintaining Pan-ERBB Blockade Following Platinum-based Induction Chemotherapy in Patients With EGFR Mutated, Metastatic Non-small-cell Lung Cancer Progressing After Treatment With Afatinib as First EGFR-targeting Agent

This study aims to compare the efficacy of afatinib maintenance with pemetrexed maintenance following induction therapy with platinum/ pemetrexed in patients with metastatic epidermal growth factor receptor (EGFR) mutated non-small-cell lung cancer (NSCLC) progressing after first-line treatment with afatinib with respect to progression-free survival.

NCT02488694 Non-small-cell Lung Cancer With Somatic EGFR Mutations
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Afatinib

Description: 40 mg/d
Type: Drug
Group Labels: 1

Arm A: Afatinib

Name: Pemetrexed

Description: 500 mg/m² i.v. on d1 of each 21-day cycle
Type: Drug
Group Labels: 1

Arm B: Pemetrexed

Primary Outcomes

Description: The primary endpoint of this study is progression-free survival (RECIST 1.1).

Measure: Progression-free survival

Time: 40 months

Secondary Outcomes

Description: Efficacy measure

Measure: Overall survival

Time: 40 months

Description: Objective response rate (ORR), clinical benefit rate (RECIST 1.1); Efficacy measure

Measure: Objective response rate

Time: 40 months

Description: Health-Related Quality of Life (HRQoL)

Measure: Quality of Life

Time: 40 month

Description: Safety, toxicity (intensity and incidence of adverse events, graded according to US NCI CTCAE Version 4.03)

Measure: Safety (intensity and incidence of adverse events, graded according to US NCI CTCAE Version 4.03)

Time: 40 month

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 T790M

Ability to comply with the protocol for the duration of the study, including hospital/office visits for treatment and scheduled follow-up visits and examinations Exclusion Criteria: 1. Systemic therapy for metastatic disease or relapse other than (a) first-line therapy with afatinib or (b) afatinib given as first EGFR-targeting agent following up to 4 courses of platinum-based chemotherapy with no disease progression between first-line chemotherapy and initiation of afatinib (prior adjuvant chemotherapy is allowed) and 3 to 4 cycles of induction chemotherapy with cisplatin or carboplatin and pemetrexed following afatinib failure 2. Prior treatment with erlotinib, gefitinib or other investigational or approved EGFR-targeting small molecules or antibodies 3. Known EGFR T790M mutation (analysis not mandatory) 4. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study 5. Extended radiotherapy within 4 weeks prior to randomization, except as follows: 1. Palliative, limited local radiation to non-target lesions (e.g. --- T790M ---

HPO Nodes