E-Newsletter - October 2020
Spotlight on Alliance Trials

Alliance Trial Studies Side Effects of Pembrolizumab WITH, WITHOUT Chemotherapy in OLDER PATIENTS with Advanced Non-small Lung Cancer

Alliance A171901: Older non-small lung cancer patients (>/= 70 years of age) treated with first-line MK-3475 (pembrolizumab) +/- chemotherapy (oncologist's/patient's choice)

Early investigator Melisa L. Wong, MD, MAS, of University of California San Francisco, together with Aminah Jatoi, MD, of Mayo Clinic, are leading Alliance A171901, a trial that studies the side effects of pembrolizumab in older patients with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has recurred and spread to other places in the body.

Investigators confirm that there is currently limited data on the side effect profile of immunotherapy in large groups of patients 65 years or older. This is a result of poor enrollment of older patients to clinical trials, which can be due to a number of factors. Additionally, outcome data in this same population remains limited. Given the increasing number of cancer diagnoses in older adults, it is important to better understand both toxicity and efficacy of agents such as pembrolizumab. 

This trial’s primary objective is to estimate the adverse event profile of pembrolizumab over the first six months of treatment, in patients with non-small cell lung cancer who are 70 years of age or older. Patients have the option of receiving pembrolizumab with or without chemotherapy in a first-line setting.

Patients will be assigned to one of two groups based on what the patient and oncologist decide is most appropriate. All treatments are given intravenously on the first day of each cycle. Each cycle can last 21 days, but the trial allows for patients to receive pembrolizumab on a 42-day cycle. Those in Group 1 will receive pembrolizumab (MK-3475) alone. Those in Group 2 will receive pembrolizumab (MK-3475) along with two chemotherapy drugs: pemetrexed and carboplatin on the first day of each cycle. Patients will continue receiving the treatment until their cancer progresses, the patient or oncologist decide to stop, or side effects preclude further therapy. Patients will also be asked to complete four questionnaires and a geriatric assessment.

For complete information on the trial design, treatment plan, and patient eligibility, refer to the study protocol, which can be found on the  Alliance website or the CTSU website.  

Study Chairs: Melisa L. Wong, MD, MAS, University of California San Francisco | E-mail: melisa.wong@ucsf.edu and Aminah Jatoi, MD, Mayo Clinic | E-mail: Jatoi.Aminah@mayo.edu
Activated: 10/01/2020 | Status: New recruiting patients
CT.gov Link: http:/bit.ly/Alliance-A171901


For other articles in this issue of Alliance E-News, see below.