Clinical trial · Interventional
TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in recruitment due to approval of maintenance pemetrexed treatment
Summary
Brief summary (as posted)
This study is: * A multicenter, prospective, randomized, phase 3 trial. * To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer. * 276 patients will be recruited.
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 |
|---|---|---|---|
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Taxotere | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Taxotere
- description
- Docetaxel plus Cisplatin
- interventionNames
- Drug: Taxotere
- type
- ACTIVE_COMPARATOR
- label
- Pemetrexed
- description
- Pemetrexed plus Cisplatin
- interventionNames
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- one year
- description
- months after beginning of first cycle chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years old * ECOG performance status 0-2 * Non-squamous cell type non-small cell lung cancer (NSCLC) * Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery or radiation therapy * No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed. * No prior immunotherapy, biologic therapy * Measurable lesion with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Hemoglobin \>=9.0g/dl, Platelet \>=100,000/uL, neutrophil \>=1,500 /uL Creatinine \<=1.5 x upper normal limit or creatinine clearance \>=60 mL/min Bilirubin \<=1.5 x upper normal limit, Transaminases \<=2 x upper normal limit Alkaline phosphatase \<=2 x upper normal limit * Written informed consent Exclusion Criteria: * Pregnancy, Lactating woman * Woman in child bearing age who refuses to do pregnancy test * Moderate or greater than grade 1 motor or sensory neurotoxicity * Hypersensitivity to taxane * Comorbidity or poor medical conditions * Other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in situ) * Concurrent treatment with other investigational drugs within 30 days before randomization * Active treatment with other anticancer chemotherapy * EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S)
References
Publications (0)
Data not yet available