A Study Comparing Pemetrexed Plus Cisplatin Versus Pemetrexed Alone in NSCLC Patients Who Have Progressed on First Line EGFR-TKI
- Registration Number
- NCT03050437
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 96
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pem/Cis Cisplatin Pem/Cis IV every 3 weeks Pem alone Pemetrexed Pem IV alone every 3 weeks Pem/Cis Pemetrexed Pem/Cis IV every 3 weeks
- Primary Outcome Measures
Name Time Method progression-free survival 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of