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

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)

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03050437

Enrollment

Registered

2017-02-10

Start date

2013-03-31

Completion date

2017-03-31

Last updated

2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Failed in First Line EGFR-TKI, EGFR Activating Mutation, Pemetrexed

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.

Interventions

DRUGCisplatin

cisplatin is added to Pem/cis arm

DRUGPemetrexed

Pem is applied to both arms

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
progression-free survival	2 years

Countries

South Korea

Contacts

Primary ContactJu Yeon Park, RN

jy1223.park@samsung.com82-2-3410-3459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026