Study on Tuvusertib and Cemiplimab for Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• Diagnosed with non-squamous non-small cell lung cancer (NSCLC) confirmed by lab tests.
• Cancer has worsened during or after receiving:
  • Up to one line of anti-PD-(L)1 therapy for advanced cancer.
  • Platinum-based therapy for advanced cancer, either with or after anti-PD-(L)1 therapy. If platinum-based therapy was given after surgery, cancer must have worsened within 6 months of the last dose.
  • A previous response of stable disease or better with anti-PD-(L)1 therapy.
  • Cancer must have worsened while on anti-PD-(L)1 therapy or within 16 weeks after the last dose.
• Have measurable cancer according to specific criteria.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have adequate blood, liver, and kidney function as defined in the study.
• For Phase 2a: Must have a central liquid biopsy to analyze tumor changes.
• Other criteria as defined in the study may apply.

Exclusion Criteria

• Have tumors with specific genetic changes (EGFR or ALK) that can be targeted by other treatments. Tumors with other genetic changes may be eligible if only one line of targeted therapy has been used.
• Have had another cancer within the last 3 years, except for certain skin cancers or cervical cancer that are considered cured with low risk of return.
• Have known brain metastases unless they are stable.
• Have a history of lung inflammation (pneumonitis) that required treatment with steroids or have current lung disease.
• Other criteria as defined in the study may apply.