NL-OMON34015Not yet recruitingPhase 3
A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence: NVALT-8A - NVALT-8A
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 864
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Age >= 18 years
- •- Patients with resectable NSCLC
- •- SUVmax < 10
- •- Performance score <= 2 before chemotherapy.
- •- Adequate organ function before administration of chemotherapy, including:
- •Adequate bone marrow reserve: ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.
- •Hepatic: bilirubin <= 1.5 x ULN, AP, ALT, AST <= 3.0 x ULN.
- •Renal: calculated creatinine clearance >= 60 ml/min based on the Cockroft and Gault formula.
- •- Patients must sign and date a written Independent Ethics Committee approved informed consent form.
Exclusion Criteria
- •- Patients with wedge or segmental resection.
- •- Patients with stage IA NSCLC
- •- Prior chemotherapy or radical radiotherapy for NSCLC.
- •- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
- •- Concomitant treatment with any other experimental drug under investigation.
- •- History of any active malignancy (other than NSCLC) unless treated more than 3 years with curative intent and no recurrence, except non-melanoma skin cancer or in situ cervical cancer.
- •- Pregnancy
- •- Women of child-bearing potential not using effective means of contraception
Investigators
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