Clinical trial NCT03776032: A Novel Erythropoiesis Stimulating Protein (NESP; Darbopoetin Alfa) for the Treatment of Anemia in Lung Cancer Patients Receiving Multi-cycle Platinum-Containing Chemotherapy
Official title: A Double-Blind, Placebo Controlled, Randomised Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Lung Cancer Subjects Receiving Multicycle Platinum-Containing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Lung cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2018-12-14
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to compare the effectiveness of darbopoetin alfa to placebo in the treatment of anemia in adults with lung cancer receiving multicycle platinum-containing chemotherapy, by assessing the percentage of participants who received red blood cell (RBC) transfusions during weeks 5-12 inclusive.


Eligibility criteria: Inclusion Criteria:

* Lung cancer (either small cell \[SCLC\] or non-small cell \[NSCLC\])
* At least 12 additional weeks of platinum containing cyclic chemotherapy planned regardless of cycle length
* Anemia (hemoglobin ≤ 11.0 g/dL) as assessed by a local or central laboratory result within 7 days before study day 1 (the first scheduled day of on-study chemotherapy and the first day of study drug administration)
* Life expectancy of at least 6 months, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Anemia predominantly due to the cancer or chemotherapy (i.e.. serum folate ≥ 4.5 nmol/L (≥ 2.0 ng/mL) and vitamin B 12 ≥ 148 pmol/L (≥ 200 pg/mL), no overt hemolysis, and no overt gastrointestinal bleeding or bleeding due to recent surgery)
* Adequate renal function (creatinine ≤ 177gmol/L (≤ 2.0 mg/dL) and adequate hepatic function (bilirubin ≤ 1.5 times central laboratory's upper limit of normal range)
* Available for 4 weeks post administration of the last dose of study drug
* Legal age for informed consent, and written informed consent must be obtained

Exclusion Criteria:

* History of any primary hematological disorder which could cause anemia (e.g., sickle cell anemia)
* Received prior whole pelvis radiation therapy
* Uncontrolled angina, congestive heart failure (New York Heart Association \> class II or known ejection fraction \< 40%)\], or uncontrolled cardiac arrhythmia.
* History of primary or metastatic malignancy involving the central nervous system (CNS). Subjects with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study providing they have had no clinical signs of nor treatment for CNS disease and no history of seizures within previous 2 years
* Uncontrolled hypertension (i.e., diastolic blood pressure \> 100 mm Hg)
* History of seizures. Subjects with a previous history of seizures will be eligible for the study providing they have had no evidence of seizure activity and have been free of anti-seizure medication for the previous 5 years
* Evidence of clinically significant systemic active infection or chronic inflammatory disease (e.g., rheumatoid arthritis)
* Iron deficiency (transferrin saturation \< 15% and ferritin \< 10 μg/L (\< 10 ng/mL))
* Received \> 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization
* Received erythropoietin therapy within 8 weeks before randomization
* Known positive test for human immunodeficiency virus (HIV) infection
* Receiving, or not yet 30 days past the end of receiving, another investigational agent or device not approved in any indication.
* Pregnant or breast feeding females.
* Not using adequate contraceptive precautions
* Prior treatment with NESP
* Previously randomized in this study
* Known hypersensitivity to mammalian-derived product
* Concerns for subject's compliance with the protocol procedure, including completion of the quality of life surveys (QOLS)

Primary outcomes:
measure: Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12
timeFrame: Weeks 5 to 12
Secondary outcomes:
measure: Time to First Red Blood Cell Transfusion During Weeks 5 to 12
timeFrame: Week 5 to week 12
measure: Percentage of Participants with a Hemoglobin Response by Week 12
timeFrame: 12 weeks
measure: Time to Hemoglobin Response
timeFrame: 12 weeks
measure: Percentage of Participants who Achieved a Sustained Hemoglobin Response by Week 12
timeFrame: 12 weeks
measure: Time to Sustained Hemoglobin Response
timeFrame: 12 weeks
measure: Percentage of Participants who Achieved a Hemoglobin Correction by Week 12
timeFrame: 12 weeks
measure: Percentage of Participants who Achieved a Sustained Hemoglobin Correction by Week 12
timeFrame: 12 weeks
measure: Time to Hemoglobin Correction
timeFrame: 12 weeks
measure: Time to Sustained Hemoglobin Correction
timeFrame: 12 weeks
measure: Change from Baseline in Hemoglobin at Week 12
timeFrame: Baseline and week 12
measure: Percentage of Participants who Received a Red Blood Cell Transfusion During Weeks 1 to 4, 5 to 8, and 9 to 12
timeFrame: Weeks 1 to 4, 5 to 8, and 9 to 12
measure: Number of Standard Units of RBCs Transfused During Weeks 5 to 12
timeFrame: Weeks 5 to 12
measure: Number of Days with RBC Transfusions During Weeks 5 to 12
timeFrame: Weeks 5 to 12
measure: Change from Baseline in the Functional Assessment of Cancer Therapy (FACT)-Anemia Subscales at Week 12
timeFrame: Baseline and week 12
measure: Number of Participants with Adverse Events
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
References: