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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03050437
• Other study ID #: 2012-12-035
• Status: Recruiting
• Phase: Phase 2
• First received: September 22, 2015
• Last updated: February 9, 2017
• Start date: March 2013
• Est. completion date: March 2017

Study information

• Verified date: February 2017
• Source: Samsung Medical Center
• Contact: Ju Yeon Park, RN
• Phone: 82-2-3410-3459
• Email: jy1223.park[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Cisplatin
cisplatin is added to Pem/cis arm
• Pemetrexed
Pem is applied to both arms

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		2 years