ECOG-ACRIN EA5163

Official Title

A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-Driven Analysis

Study Purpose

To find out whether either of these two usual approaches to treating this type of cancer is better or worse than the other.

Diagnosis

Must have histologically or cytologically confirmed stage IV non-squamous NSCLC; Patients with T4NX disease (stage IIIB) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation

Eligibility

Marker Status: PD-L1 expression Tumor Proportion Score (TPS) of at least 1% in tumor cells.

Must not have received prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC.

Chemotherapy for non-metastatic disease (ex. adjuvant therapy) or immunotherapy for locally advanced stage III disease is allowed if at least 6 months have elapsed since the prior therapy and registration.

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

Intervention

• ARM A:  1st line MK-3475 (prembrolizumab) followed by 2nd line pemetrexed/carboplatin.
• ARM B:  1st line MK-3475 (pembrolizumab) followed by 2nd line MK-3475 (pembrolizumab)/pemetrexed/carboplatin.
• ARM C:  MK-3475 (pembrolizumab)/pemetrexed/carboplatin induction followed by pemetrexed/MK-3475 (pembrolizumab) maintenance.

Patients will be followed every 3 months after treatment ends for the first 3 years, then every 6 months for the final 2 years, for a total of 5 years after treatment.