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

NCT ID: NCT03050437

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-03-31

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pem/Cis

Pem/Cis IV every 3 weeks

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

cisplatin is added to Pem/cis arm

Pemetrexed

Intervention Type: DRUG

Pem is applied to both arms

Pem alone

Pem IV alone every 3 weeks

Group Type: ACTIVE_COMPARATOR

Pemetrexed

Intervention Type: DRUG

Pem is applied to both arms

Interventions

Cisplatin

cisplatin is added to Pem/cis arm

Intervention Type: DRUG

Pemetrexed

Pem is applied to both arms

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Myung-Ju Ahn

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myung-Ju Ahn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Ju Yeon Park, RN

Role: CONTACT

jy1223.park@samsung.com

82-2-3410-3459

Facility Contacts

Myung-Ju Ahn, Ph.D.

Role: primary

silkahn@skku.edu

822-3410-1795

Other Identifiers

2012-12-035

Identifier Type: -

Identifier Source: org_study_id