Clinical trial · Interventional
A Study for Non-Smoker Patients With Nonsquamous Non-Small Cell Lung Cancer
A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed Alone, and Erlotinib Alone, as Second-Line Treatment for Non-Smoker Patients With Locally Advanced or Metastatic Nonsquamous 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 purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.
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 |
|---|---|---|---|
| erlotinib | Drug | Erlotinib | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Pemetrexed + Erlotinib
- description
- Pemetrexed 500 milligrams per meter squared (mg/m\^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
- interventionNames
- Drug: pemetrexed
- Drug: erlotinib
- type
- ACTIVE_COMPARATOR
- label
- Erlotinib
- description
- Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
- interventionNames
- Drug: erlotinib
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer * Patients must be non-smokers * Patients must have at least one measurable lesion * Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale * Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease. Exclusion Criteria: * Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication * Patients who have previously received treatment with drugs against the human epidermal growth factor receptors * Patients who have previously received treatment with drugs which have similar targets as Pemetrexed * Patients who have any known significant ophthalmologic abnormalities of the surface of the eye * Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed
References
Publications (1)
- DERIVEDLee DH, Lee JS, Kim SW, Rodrigues-Pereira J, Han B, Song XQ, Wang J, Kim HK, Sahoo TP, Digumarti R, Wang X, Altug S, Orlando M. Three-arm randomised controlled phase 2 study comparing pemetrexed and erlotinib to either pemetrexed or erlotinib alone as second-line treatment for never-smokers with non-squamous non-small cell lung cancer. Eur J Cancer. 2013 Oct;49(15):3111-21. doi: 10.1016/j.ejca.2013.06.035. Epub 2013 Jul 24. PMID 23890768