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

Phase 2

• Conditions: NSCLC
• Interventions: Drug: Pemetrexed 500mg/m2 iv; Drug: Pemetrexed 500mg/m2 iv and Gefitinib 250 mg

• Registration Number: NCT01579630
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Detailed Description

The hypothesis tested in this study is that gefitinib / pemetrexed as maintenance therapy in patients with advanced (stage IV) EGFR mutation negative nonsquamous NSCLC who respond to 4 cycles of pemetrexed / cisplatin or pemetrexed/carboplatin as first-line therapy will achieve longer PFS than pemetrexed alone. We assume a median PFS of 4 months for patients receiving pemetrexed alone and the hazard ratio of pemetrexed alone compared to gefitinib/pemetrexed would be 0.42. It also indicates that the median PFS in gefitinib/pemetrexed group will be approximately 9.52 months. This is a 2-arm study in a 1:1 randomisation. Assuming an uniform accrual of 12-month with an addition of 12-month follow-up period, the total evaluable number of patients will be 52 to achieve a power of 80% and one-sided significance level of 0.025 to detect such difference between gefitinib/pemetrexed and pemetrexed alone.

Assuming 60% of patients respond (CR/PR/SD) to 4 cycles of pemetrexed/gefitinib, and among them 60% are EGFR mutation negative, 144 patients need to be enrolled to receive 4 cycles of pemetrexed/cisplatin or pemetrexed/carboplatin as first-line therapy.

Besides, the result of anaplastic lymphoma kinase gene (ALK) mutation will be retrospectively collected if the mutation is available for study patients during the study period.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-18
• Primary Completion: 2013-06
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-03
• Last Update Posted: 2014-04-04
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pemetrexed 500mg/m2 iv	Pemetrexed 500mg/m2 iv	-
Pemetrexed 500 mg/m2 i.v. and Gefitinib 250 mg	Pemetrexed 500mg/m2 iv and Gefitinib 250 mg	-

Primary Outcome Measures

Name	Time	Method
Progression free survival	up to 4 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall objective tumour response	up to 1 year	The RECIST (V1.1) criteria will be used to assess objective tumour response. Details of target and non-target lesions will be collected on the appropriate CRF pages and used to calculate tumour response. Post-baseline tumour evaluations should use the same modality (CT scan or magnetic resonance imaging \[MRI\]) as used at baseline and should preferably be undertaken at the same institution.

Trial Locations

Locations (1)

Veterans General Hospital -Taipei; 🇨🇳 Taipei, Taiwan