Clinical trial · Interventional
Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
The International Tirazone Triple Trial (i3T): A Phase III, Randomized Efficacy And Safety Study Of The Combination Chemotherapy With Tirapazamine+Cisplatin+Vinorelbine Versus Cisplatin+Vinorelbine In Subjects With Inoperable, Previously Untreated, 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if cisplatin and vinorelbine are more effective with or without tirapazamine in treating non-small cell lung cancer PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus vinorelbine with or without tirapazamine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| tirapazamine | Drug | — | UNRESOLVED |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIB or IV Newly diagnosed or recurrent disease Measurable lesions At least 10 mm by spiral CT scan OR At least 20 mm by conventional techniques Previously irradiated lesions are considered measurable provided they progressed or appeared after completion of radiotherapy The following are considered nonmeasurable: Pleural or pericardial effusions Cystic lesions Lymphangitis pulmonis Bony x-ray abnormalities Abnormal scans with nonmeasurable filling defects No symptomatic brain metastasis or CNS involvement by CT scan or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine normal Other: No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell carcinoma that is not likely to recur No history of allergic reactions to diuretics or antiemetics (e.g., 5-HT3 antagonists) used on this study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biologic therapy for NSCLC Chemotherapy: No prior chemotherapy for NSCLC No prior platinum-based chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to potential indicator lesion(s) At least 4 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgical procedure(s) Other: At least 30 days since prior investigational drug
References
Publications (0)
Data not yet available