A Study Comparing Pemetrexed Plus Cisplatin Versus Pemetrexed Alone in NSCLC Patients Who Have Progressed on First Line EGFR-TKI

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Cisplatin
* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pem/Cis<br>Pem/Cis IV every 3 weeks | Drug: Cisplatin<br>* cisplatin is added to Pem/cis arm<br>Drug: Pemetrexed<br>* Pem is applied to both arms<br>|
| Active Comparator: Pem alone<br>Pem IV alone every 3 weeks | Drug: Pemetrexed<br>* Pem is applied to both arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Failed in First Line EGFR-TKI, EGFR Activating Mutation, Pemetrexed