Clinical trial NCT03050437: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Failed in First Line EGFR-TKI
EGFR Activating Mutation
Pemetrexed
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: progression-free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Myung-Ju Ahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: