Clinical trial · Interventional
Pemetrexed With or Without Carboplatin for Elderly Non-squamous Non-small Cell Lung Cancer
A Randomized, Open-label, Phase III Study Comparing Pemetrexed With and Without Carboplatin in Elderly Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
- 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)
The number of NSCLC patients above 70 years of age who are non-squamous histology is increasing around the world. Although previous guidelines often recommend single agent therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard monotherapy in elderly. We hypothesize that for elder patients (≥70 years of age) with non-squamous NSCLC, pemetrexed and carboplatin is more effective than pemetrexed monotherapy in terms disease progression, overall survival, and quality of life and tolerability.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PemCarbo | Drug | — | UNRESOLVED |
| Pem only | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PemCarbo
- description
- Pemetrexed/Carboplatin arm
- interventionNames
- Drug: PemCarbo
- type
- ACTIVE_COMPARATOR
- label
- Pem only
- description
- Pemetrexed arm
- interventionNames
- Drug: Pem only
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- The study lasts for 30 months of which subject accrual occurs in the first 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced non-squamous non-small cell lung cancer (stage IV, AJCC 7th) * Age 70 years old or older * Eastern Cooperative Oncology Group performance status 0-1 * Measurable or assessable disease as defined by RECIST 1.1 * Estimated life expectancy of more than 3 months * Adequate bone marrow function(Absolute Neutrophil Count (ANC) ≥ 1,500/µL, platelets ≥ 100,000/µL, hemoglobulin ≥ 9 g/dL) * Adequate renal function: creatinine \< 1 x upper normal limit (UNL) or creatinine clearance(Ccr) using Cockroft and Gault formula ≥45 ml/min * Adequate hepatic function: bilirubin \< 1.5 x UNL, AST/ALT levels \< 3 x UNL, alkaline phosphatase \< 3 x UNL (except in case of bone metastasis without any liver disease) * Written informed consent Exclusion Criteria: * Prior systemic chemotherapy or biological therapy * Contraindication to any drug contained in the chemotherapy regimen * Clinically significant third-space fluid collections (e.g. pleural effusion and pericardial effusion) that cannot be controlled by drainage or other procedures prior to study enrollment * Active infection which would compromise the patient's ability to tolerate treatment * Requirement for major surgery within 4 weeks of study entry * Myocardial infarction, uncontrolled arrhythmias, symptomatic angina pectoris, cardiac failure within the previous 6 months * Unable to discontinue administration of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs); Aspirin or NSAIDs should be at least 5 days before pemetrexed administration * Presence or history of CNS metastasis (except if adequately treated and is not receiving steroid therapy for at least 2 weeks; at least 2 weeks for whole brain radiation or at least 1 week for gamma knife surgery) * Peripheral neuropathy ≥ grade 2 * History of another malignancy within the last five years except cured basal cell carcinoma of skin, cured carcinoma in-situ of uterine cervix and cured thyroid malignancy * Pregnant or lactating women, women of childbearing potential not employing adequate contraception * Other serious illness or medical conditions
References
Publications (0)
Data not yet available