Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios.

Defined as the proportion of patients who remained alive and progression-free at 6 months. Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios.

Toxicity will be determined using the Common Terminology Criteria for Adverse Events (CTCAE). Toxicity will be assessed by summaries by CTCAE grade.

Will be evaluated via RECIST 1.1 criteria. Best objective response rate is defined as the proportion of patients with measurable disease at baseline achieved complete response (CR) or partial response (PR) as best response from the start of the treatment until disease progression/recurrence or start of non-protocol therapy. Patients who do not start treatment and patients who do not have any follow-up disease evaluation and do not meet RECIST criteria for clinical progression are coded as not evaluable. Patients who are not evaluable are included in the calculation of response rates (as non-responders).

Will relate gut microbe abundances to treatment outcomes, toxicity, and geriatric assessments.

Quality of life evaluations will be conducted using questionnaires at time of disease evaluation per Functional Assessment of Cancer Therapy-Lung version 4. QOL assessment will be gathered and the changes in QOL between the two treatment arms will be compared using Wilcoxon rank sum test. The comparison of changes in QOL using Wilcoxon rank sum test will also be done at 6 months given the high mortality rate in this population and the expectation that we may see differences in OS by that timepoint. Point estimates of all endpoints will be accompanied by the corresponding 95% confidence intervals. Point estimates of OS and the corresponding 95% confidence intervals by sex, race and ethnicity will be provided.