Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pem/Cis
- description
- Pem/Cis IV every 3 weeks
- interventionNames
- Drug: Cisplatin
- Drug: Pemetrexed
- type
- ACTIVE_COMPARATOR
- label
- Pem alone
- description
- Pem IV alone every 3 weeks
- interventionNames
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available