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ECOG-ACRIN EA5142

Status:

Recruiting | Phase III

Official Title:

Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab after Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

Study Purpose:

To evaluate whether adjuvant therapy with nivolumab will result in improved overall survival (OS) and/or disease-free survival (DFS) over standard observation in patients with Stage IB≥4cm, II and IIIA, NSCLC following surgical resection and standard adjuvant therapy.

Interventions:

  • Study agents: Nivolumab vs observation
  • Nivolumab is given by IV infusion every 2 weeks for up to 1 year
  • Patients on the observation arm are followed every 3 months for 2 years, then every 6 months until year 4, then yearly.
  • CT scans are completed for both arms every 6 months for 4 years then every year for 6 years

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

ALK-positive Stage IB, II, IIIA Non-small cell lung cancer 

Eligibility:

Previously registered to ALCHEMIST SCREEN A151216 PRIOR TO RANDOMIZATION

ECOG performance status 0 or 1.

Complete surgical resection with negative margins.

Tumors must have PD-L1 tested centrally as part of the ALCHEMIST SCREEN STUDY.

No prior treatment with an immune checkpoint inhibitor.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

ECOG ACRIN EA5142

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!