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

Phase 3

• Conditions: lungcancer; 10038666; Non-smal cell lung cancer

• Registration Number: NL-OMON34015
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 864

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Recurrence-free survival. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary end-points are overall survival, dose intensity of subsequent cycles,<br /><br>quality of life, toxicity, health economics. Exploratory endpoints are analysis<br /><br>of blood and tumor samples for prognostic markers, genomics/proteomics.</p><br>