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

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Pemetrexed; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03050437

2012-12-035

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Pem/Cis

Experimental group

Description:

Pem/Cis IV every 3 weeks

Treatment:

Drug: Pemetrexed

Drug: Cisplatin

Pem alone

Active Comparator group

Description:

Pem IV alone every 3 weeks

Treatment:

Drug: Pemetrexed