Recruitment

Recruitment Status
Terminated
Estimated Enrollment
765

Inclusion Criterias

Total serum bilirubin ≤ 1.5 x ULN
All fertile patients should use safe contraception
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy.
...
Total serum bilirubin ≤ 1.5 x ULN
All fertile patients should use safe contraception
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy.
Creatinine clearance > 45 ml/min
Histologically or cytologically confirmed non-squamous non-small cell lung cancer
Measureable disease according to the RECIST 1.1
Platelets ≥ 100 x 109/L
Stage IIIB ineligible for curative therapy or stage IV disease
Able to discontinue NSAIDs and ASA if reduced renal function
Written informed consent
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Previous radiotherapy is acceptable provided there are measurable, previously not irradiated lesions present
ECOG Performance 0-2

Exclusion Criterias

known hypersensitivity or contraindications for the study drugs (vinorelbine, carboplatin, pemetrexed, B12, folate)
pregnant or lactating women
activating EGFR-mutation or ALK-translocation detected
...
known hypersensitivity or contraindications for the study drugs (vinorelbine, carboplatin, pemetrexed, B12, folate)
pregnant or lactating women
activating EGFR-mutation or ALK-translocation detected
prior systemic therapy for advanced non-small-cell lung cancer (including EGFR-TKI). Previous chemotherapy (e.g. adjuvant after surgery or for other cancer) is allowed if ≥ 3 months since the last course was administered.
conditions - medical, social, psychological - which could prevent adequate information and follow-up
serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
clinically active cancer other than NSCLC

Summary

Conditions
Carcinoma, Non-Small-Cell Lung
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

In previous studies without maintenance therapy, median overall survival (OS) for performance status (PS) 0-1 patients has been approximately 9 months, corresponding to 6 months from randomization in this study. We consider an improvement in overall survival of two months to be the minimum differenc...

In previous studies without maintenance therapy, median overall survival (OS) for performance status (PS) 0-1 patients has been approximately 9 months, corresponding to 6 months from randomization in this study. We consider an improvement in overall survival of two months to be the minimum difference that will lead to routine use of maintenance pemetrexed in Norway. To demonstrate an improvement in median overall survival from 6 to 8 months with an α =0.05 and β =0.20, 198 evaluable patients are required on each arm. We expect a drop-out rate of maximum 10 %, and therefore intend to randomize a total of 436 patients (PS 0-1) - of which we expect 150 to be 70 years or older. Sample size is calculated on PS 0-1 patients only. In addition, PS 2 patients will be randomized until the required number of PS 0-1 patients have been accrued. We estimate that a total of 100 PS 2 patients will be enrolled - sufficient for hypothesis-generating analyses of the benefit of maintenance therapy in elderly and PS 2 patients. Based on experience from our previous studies we estimate that approximately 30% of patients will not complete or progress during induction chemotherapy; or be ineligible due deterioration of PS. Consequently, we need to include approximately 765 patients.

Inclusion Criterias

Total serum bilirubin ≤ 1.5 x ULN
All fertile patients should use safe contraception
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy.
...
Total serum bilirubin ≤ 1.5 x ULN
All fertile patients should use safe contraception
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy.
Creatinine clearance > 45 ml/min
Histologically or cytologically confirmed non-squamous non-small cell lung cancer
Measureable disease according to the RECIST 1.1
Platelets ≥ 100 x 109/L
Stage IIIB ineligible for curative therapy or stage IV disease
Able to discontinue NSAIDs and ASA if reduced renal function
Written informed consent
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Previous radiotherapy is acceptable provided there are measurable, previously not irradiated lesions present
ECOG Performance 0-2

Exclusion Criterias

known hypersensitivity or contraindications for the study drugs (vinorelbine, carboplatin, pemetrexed, B12, folate)
pregnant or lactating women
activating EGFR-mutation or ALK-translocation detected
...
known hypersensitivity or contraindications for the study drugs (vinorelbine, carboplatin, pemetrexed, B12, folate)
pregnant or lactating women
activating EGFR-mutation or ALK-translocation detected
prior systemic therapy for advanced non-small-cell lung cancer (including EGFR-TKI). Previous chemotherapy (e.g. adjuvant after surgery or for other cancer) is allowed if ≥ 3 months since the last course was administered.
conditions - medical, social, psychological - which could prevent adequate information and follow-up
serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
clinically active cancer other than NSCLC

Locations

Trondheim
Trondheim

Tracking Information

NCT #
NCT02004184
Collaborators
St. Olavs Hospital
Investigators
  • Principal Investigator: Bjørn H Grønberg, MD PhD Norwegian University of Science and Technology
  • Bjørn H Grønberg, MD PhD Norwegian University of Science and Technology