Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy

Recruiting in Palo Alto (17 mi)

+527 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amgen

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a study in patients with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV non-small cell lung cancer (NSCLC). The primary objective of the study is to demonstrate that overall survival (OS) is not worse in participants on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL compared to participants treated with placebo.

Eligibility Criteria

Inclusion Criteria

Subjects with stage IV NSCLC (not recurrent or re-staged).

Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.

Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization.

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Treatment Details

Interventions

Darbepoetin alfa (Erythropoiesis-Stimulating Agent)
Placebo (Other)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Darbepoetin alfaExperimental Treatment1 Intervention

Participants received darbepoetin alfa 500 µg once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.

Group II: PlaceboPlacebo Group1 Intervention

Participants received placebo once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.