Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer

The Norwegian Lung Cancer Study Group

Status and phase: Completed; Phase 3

Conditions: Advanced Non-Small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Gemcitabine; Drug: Vinorelbine

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00737867

Eudra-CT-nr 2006-002927-18

11066741577

Details and patient eligibility

About

The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.

Enrollment: 444 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-small cell lung cancer stage IIIB or IV
• Not eligible for radical radiotherapy or surgery
• WHO performance status 0-2

Exclusion criteria

• Pregnancy
• Other clinical active cancer disease
• ALAT/ALP more than 3 times upper normal limit, bilirubin >1.5 upper limit
• Bowel disease that causes malabsorption

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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444 participants in 2 patient groups

A

Experimental group

Description:

Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2 Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2 All patients will receive a maximum of 3 courses with an interval of 3 weeks

Treatment:

Drug: Gemcitabine

Drug: Vinorelbine

Drug: Vinorelbine

B

Active Comparator group

Description:

Day 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Carboplatin infusion AUC = 5 (Calvert's formula) Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 All patients will receive a maximum of 3 courses with an interval of 3 weeks

Treatment:

Drug: Vinorelbine

Drug: Vinorelbine

Drug: Carboplatin