Description:
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.
Title
- Brief Title: A Study Comparing Pemetrexed Plus Cisplatin Versus Pemetrexed Alone in NSCLC Patients Who Have Progressed on First Line EGFR-TKI
- Official Title: 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)
Clinical Trial IDs
- ORG STUDY ID:
2012-12-035
- NCT ID:
NCT03050437
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
Drug | Synonyms | Arms |
---|
Cisplatin | | Pem/Cis |
Pemetrexed | | Pem alone |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Pem/Cis | Experimental | Pem/Cis IV every 3 weeks | |
Pem alone | Active Comparator | Pem IV alone every 3 weeks | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | progression-free survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Samsung Medical Center |
Trial Keywords
- Failed in First Line EGFR-TKI
- EGFR Activating Mutation
- Pemetrexed
Last Updated
February 10, 2017