Clinical trial · Interventional
Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC
The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma)
NCT03374280CI-TRIAL-00037853unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC
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 |
|---|---|---|---|
| pemetrexed/cisplatin | Drug | — | UNRESOLVED |
| pemetrexed/cisplatin intercalating gefitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- pemetrexed/cisplatin intercalating gefitinib
- description
- pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 ;gefitinib 250mg d3-20d, to 4 cycles. pemetrexed 500mg/m2 d1; gefitinib 250mg d2-20d to disease progression or untolerable
- interventionNames
- Drug: pemetrexed/cisplatin intercalating gefitinib
- type
- ACTIVE_COMPARATOR
- label
- pemetrexed/cisplatin
- description
- pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable
- interventionNames
- Drug: pemetrexed/cisplatin
Primary outcomes (1)
- measure
- disease progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1.Histological or cytological diagnosis of small-cll lung cancer histology 2.18 years or older 3.Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2 4.Local stage SCLC without distant metastases 5.After 1st-line chemotherapy (EP or IP) at least 4 cycles 6.After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy 7.CR or PR assessment by RECIST(1.0) before randomized 8.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L 9.Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases 10.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula) Exclusion Criteria: 1. Mixed non-small cell lung cancer histology 2. Neck and supraclavicular lymph node metastasis 3. Be allergic to temozolomide or intolerable to radiotherapy 4. Any unstable systemic disease 5. Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.