Feasibility and Preliminary Efficacy of Exercise during Immunotherapy in Patients with Lung cancer: The INHALE Trial

The purpose of this study is to determine whether a 12-week, home-based, virtually supervised
exercise intervention is feasible and improves various health outcomes among individuals with
advanced lung cancer receiving immunotherapy.

The names of the study interventions involved in this study are:

- High-intensity interval training (HIIT) (Home-based, virtually supervised, high
intensity training in an interval fashion)

- Moderate-intensity continuous training (MICT) (Home-based, virtually supervised,
moderate intensity in a continuous fashion)

- Usual care (UC)

Inclusion Criteria:

- Age ≥18 years; due to the rarity of the disease in those <18 years, this age bracket
will not be included.

- Histologically diagnosed with metastatic Non-small cell lung cancer (NSCLC).

- Having been receiving single-agent anti-PD-1 or anti-PD-L1 monoclonal antibodies for
at least one month (e.g., pembrolizumab, nivolumab, atezolizumab, durvalumab,
cemiplimab, and avelumab) with a plan to continue for at least 12 weeks prospectively
at the time of recruitment.

- Not receiving other concurrent systemic treatment (e.g., chemotherapy or targeted
therapy).

- Medical clearance to perform exercise intervention and testing by their treating
oncologist.

- No uncontrolled medical conditions that could be exacerbated with exercise (e.g.,
uncontrolled hypertension or diabetes).

- Ability to communicate and complete written forms in English.

- Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic
exercise per week over the past month.

- Ability to understand and the willingness to sign informed consent prior to any
study-related procedures.

- Willing to travel to DFCI for necessary data collection.

Exclusion Criteria:

- Receiving other concurrent systemic treatment for NSCLC such as chemotherapy or
targeted therapy. This study is to exclusively target patients receiving
anti-PD-1/PD-L-1 where other treatments may impact the study outcomes of intervention
feasibility and efficacies.

- Participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week
over the past month. This study targets insufficiently active persons to assess the
effect of the described exercise intervention, where additional exercise done
regularly will contaminate the intervention outcomes.

- Unstable comorbidities that prevent participation in moderate-to-vigorous intensity
exercise. Patients with unstable comorbidities may develop unexpected adverse events
from exercise. For the purpose of patients' safety, as well as because part of this
study involves remote, home-based exercise where close supervision is not possible,
patients with unstable medical conditions are excluded.

- Subjects who in the opinion of the investigator may not be able to comply with the
safety monitoring requirements of the study.

- Development of second malignancy (except for basal cell carcinoma or squamous cell
carcinoma of the skin) that requires concurrent treatment, which would interfere with
this study.