A Safety and feasibility study of standard dosing day 1 carboplatin AUC 5 every 3rd weeks with daily Navelbine® 20/30mg (oral) during 4 cycles (12 weeks) for the treatment of advanced NSCLC; A feasibility study

Phase 1

• Conditions: Patients with metastatic or locally advanced Non-small-cell lung cancer (NSCLC); MedDRA version: 20.0Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 100000015855; MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000015841; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000659-23-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-30
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Written (personally dated and signed) informed consent.
2. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and/or the follow-up schedule.
3. ECOG performance status 0-1 (also PS 2 after the first 6 patients if acceptable toxicity according to chapter 8: Toxicity and dose modifications.
4. Life expectancy = 10 weeks
5. Cytological or Histological confirmed squamous and non-squamous NSCLC in 1st or 2nd line where the investigator finds the patient suitable.
6. First line in stage IV NSCLC and in stage IIIB not suitable for curative treatment. Second line after immunotherapy (minimum 3 weeks after the last immunotherapy).
7. Presence of = 1 measurable lesion as per RECIST 1.1 which has not been previously irradiated.
8. Adequate bone marrow, hepatic and renal function as defined by the following laboratory values:
•Absolute neutrophil count (ANC) = 1.5 x 109/L.
•Platelet count = 100 x 109/L.
•Haemoglobin = 10 g/dL or = 6.2 mmol/L.
•Total serum bilirubin = 1.5 x ULN (= 3 x ULN in case of liver metastases).
•Liver transaminases = 2.5 x ULN (= 5 x ULN in case of liver metastases).
•Alkaline phosphatase = 5 x ULN.
•Adequate renal function
9. Palliative radiotherapy can be allowed but not to the sites used for evaluation of response. (See section 4.4).
10. Fertile men should use effective contraceptive prevention. Fertile women must be using a medically accepted method of contraception to avoid pregnancy during 2 months preceding registration, throughout the study period and up to 3 months after last dose of study treatment in such a manner that the risk of pregnancy is minimized. Women who may be pregnant should have a pregnancy test.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Patients with NSCLC disease suitable for curable treatment.
2.No recovery to = G1 side effects (exception: alopecia) of any prior anti-neoplastic treatment.
3.Current peripheral neuropathy = G2.
4.Dysphagia or inability to swallow oral medication.
5.Malabsorption syndrome or disease significantly affecting GI-function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine.
6.Other serious illness or medical condition, such as but not limited to:
a.Clinically significant cardiac disease or impaired cardiac function (such as: uncontrolled congestive heart failure requiring treatment; significant cardiac arrhythmia; conduction abnormality such as congenital long QT syndrome or high grade/complete AV-blockage; myocardial infarction within the previous 3 months, unstable angina pectoris, coronary artery bypass graft, coronary angioplasty or stenting, if < 3 months prior to registration; QTcF >480 msec at screening)
7.Unstable diabetes mellitus.
8.Uncontrolled hypercalcemia.
9.Clinically significant active infections (current or within the last 2 weeks prior to registration).
10.Previous organ allograft.
11.Concomitant treatment with strong CYP3A4-inhibitors or strong CYP3A4-inducers (discontinuation before registration is acceptable, if medically feasible and ethically acceptable).
12.Pregnant women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified