Page 11 - Delaware Medical Journal - September/October 2020

EA5163/S1709 INSIGNA: 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
The objectives of the trial are:
Primary Endpoint:
• The co-primary objective is to evaluate overall survival (OS) in each of the two experimental arms (Arms A and B) to control (Arm C).
Secondary Endpoints:
• To evaluate progression-free survival per RECIST 1.1 for Arm C versus each of Arms A and B.
• To evaluate best objective response rates per RECIST 1.1 for Arm C versus each of Arms A and B.
• To estimate toxicity within each of the treatment arms via the CTCAE criteria.
• To compare outcomes between Arms A and B.
Biomarker Objectives:
• To collect and bank tissue and blood for future research studies, including potential development of a prognostic and predictive signature for MK-3475 (pembrolizumab) in combination with chemotherapy versus MK-3475 (pembrolizumab) alone.
Eligibility:
• Patients must be age ≥ 18 years. Women must not be pregnant or lactating. ECOG Performance status 0-1.
• Patients must have histologically or cytologically confirmed stage IV non-squamous NSCLC. Patients with T4NX disease (Stage IIIB and IIIC) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation.
• Patients must have PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% in tumor cells.
• Patients must have measurable or non-measurable disease.
• Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
• Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents: to be eligible for this trial, patients should be class 2B or better.
• Patients must meet laboratory values within 14 days of randomization for CBC, liver and renal functions per protocol.
• Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or abstain from sexual intercourse from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment.
Treatment:
Arm A: 1st line MK-3475 (pembrolizumab) 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
Vitamin supplementation and steroid premedication for Pemetrexed
Please review the protocol for further clarification to the eligibility and treatment.
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
CANCER CLINICAL TRIAL
Del Med J | September/October 2020 | Vol. 92 | No. 5 203