Clinical trial · Interventional
Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers
A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" Patients With Advanced 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 efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gefitinib | Drug | Gefitinib | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pemetrexed/Cisplatin/Gefitinib
- description
- Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Gefitinib
- type
- EXPERIMENTAL
- label
- Pemetrexed/Cisplatin
- description
- Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Pemetrexed
- Drug: Cisplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV) * Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at least 4 weeks prior to study enrolment. * Have 'never smoked' (defined as having smoked \<100 cigarettes during his/her lifetime) * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 Exclusion Criteria: * Concurrent administration of any other tumor therapy * Other co-existing malignancies * Pregnancy or breast feeding * Serious concomitant disorders * Inability or unwillingness to take folic acid or vitamin B12 supplementation
References
Publications (1)
- DERIVEDAhn MJ, Yang JC, Liang J, Kang JH, Xiu Q, Chen YM, Blair JM, Peng G, Linn C, Orlando M. Randomized phase II trial of first-line treatment with pemetrexed-cisplatin, followed sequentially by gefitinib or pemetrexed, in East Asian, never-smoker patients with advanced non-small cell lung cancer. Lung Cancer. 2012 Aug;77(2):346-52. doi: 10.1016/j.lungcan.2012.03.011. Epub 2012 Apr 23. PMID 22534669