Genius Study Study to Compare Efficacy and Safety of Gefitinib/ Pemetrexed With Pemetrexed Alone as Maintenance Therapy in Patients With Stage IV EGFR Mutation Negative or T790M Single Mutation Who Respond to Pemetrexed/ Platinum as First-line Therapy

NCT01579630 | Unknown Phase 2

• 1 other identifier: D7913L00077
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to randomize 52 patients with advanced (Stage IV) EGFR mutation negative nonsquamous non-small cell lung cancer (NSCLC) who respond (CR/PR/SD) to 4 cycles of pemetrexed / cisplatin or pemetrexed/carboplatin as first-line therapy. In order to achieve that, approximately 144 treatment naïve patients with advanced nonsquamous NSCLC need to be enrolled from around 6 investigational sites in Taiwan that have expertise in lung cancer diagnosis.

Conditions

NSCLC

Keywords

NSCLC; Nonsquamous; Maintenance therapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression of disease will be calculated from the tumour measurements collected at each tumour assessment per the RECIST (V1.1) criteria and/or the date of patient death.

  up to 4 months

Secondary Outcomes (1)

• Overall objective tumour response

  up to 1 year

Study Arms (2)

Pemetrexed 500mg/m2 iv

EXPERIMENTAL

Drug: Pemetrexed 500mg/m2 iv

Pemetrexed 500 mg/m2 i.v. and Gefitinib 250 mg

EXPERIMENTAL

Drug: Pemetrexed 500mg/m2 iv and Gefitinib 250 mg

Interventions

Pemetrexed 500mg/m2 iv DRUG

EGFR mutation negative patients who continuously respond (CR, PR or SD) to the 4th cycle of pemetrexed/ cisplatin or pemetrexed/carboplatin will be randomized in a 1:1 ratio to receive either gefitinib/ pemetrexed, or pemetrexed alone as maintenance therapy until progression of disease (PD) or discontinuation of treatment for other reasons.

Pemetrexed 500mg/m2 iv

Pemetrexed 500mg/m2 iv and Gefitinib 250 mg DRUG

EGFR mutation negative patients who continuously respond (CR, PR or SD) to the 4th cycle of pemetrexed/ cisplatin or pemetrexed/carboplatin will be randomized in a 1:1 ratio to receive either gefitinib/ pemetrexed, or pemetrexed alone as maintenance therapy until progression of disease (PD) or discontinuation of treatment for other reasons.

Pemetrexed 500 mg/m2 i.v. and Gefitinib 250 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• Patients age 20 years or older
• Histological or cytological confirmed advanced (stageIV) nonsquamous NSCLC
• NSCLC treatment naïve(except patients who have pre- and post-operative non-platinum based adjuvant chemotherapy greater than 6 months prior to enrolment can be enrolled.)
• Measurable disease according to RECIST (Version 1.1) criteria
• World Health Organization (WHO) performance status (PS) of 0 to 1
• Provision of cancer tissue sample for mutation testing or the result of EGFR mutation test is negative (single T790M mutation positive patients can also be enrolled)

You may not qualify if:

• Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
• Known severe hypersensitivity to gefitinib, pemetrexed, cisplatin and carboplatin or any of the excipients of these products
• Known severe hypersensitivity to pre-medications required for treatment with pemetrexed / cisplatin or pemetrexed/carboplatin doublet chemotherapy
• Absolute neutrophil counts (ANC) less than 2.0 x 109/L (2,000/mm3), platelets less than 100 x 109/L (100,000/mm3) or haemoglobin less than 10 g/dl
• Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline
• Serum bilirubin is greater than 1.5 times the upper limit of reference range
• Serum creatinine is greater than 1.5 times the ULRR
• Unable to tolerate pemetrexed/ cisplatin or pemetrexed/carboplatin doublet chemotherapy, as judged by the investigator.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Taiwan University Hospital: collaborator
• Taichung Veterans General Hospital: collaborator
• China Medical University Hospital: collaborator
• Dalin Tzu Chi General Hospital: collaborator
• Tri-Service General Hospital: collaborator

Study Sites (1)

Veterans General Hospital -Taipei

Taipei, 112, Taiwan

Location

MeSH Terms

Interventions

Pemetrexed; Gefitinib

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Quinazolines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Chief of Section of Thoracic Oncology of the Chest Department

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 18, 2012
• Study Start: March 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

TW (1)