Phase II Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-Small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

Summary

This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life) when treating Performance Status 2 patients with the same first-line immunotherapy-based regimen as Performance Status 0-1 patients.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Pembrolizumab

  ALL PARTICIPANTS: Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle for 4 cycles.

• Drug
  Atezolizumab

  ALL PARTICIPANTS: 1,200 mg IV on day 1 over 60 minutes of each 3-week cycle for 4 cycles. If the first infusion is tolerated, then all subsequent infusions (cycles 2-4) may be delivered over 30 minutes. The subcutaneous formulation of atezolizumab may be substituted for the intravenous formulation as follows: Atezolizumab hyaluronidase-tqjs 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over 7 minutes on day 1 of each 3-week cycle for 4 cycles.

• Drug
  Cemiplimab-Rwlc

  ALL PARTICIPANTS: 350 mg IV over 30 minutes on day 1 of each 3-week cycle for 4 cycles.

• Drug
  Carboplatin

  FOR PARTICIPANTS IN EITHER ARM with non-squamous or squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR non-squamous or squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles. AUC dosing (5-6) will be selected by the treating provider.

• Drug
  Paclitaxel

Location