Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

Inclusion Criteria

• •Participants who are diagnosed with nsqNSCLC histologically or cytologically confirmed
• •Participants with Radiologically confirmed/documented disease progression during or after the following systemic therapies (all required):
• •* At most, 1 line of anti-PD-(L)1 therapy for locally advanced or metastatic disease. Rechallenge with the same anti-PD-(L)1 for disease considered sensitive to anti-PD-(L)1 therapy (e.g. after a treatment break) is considered 1 line
• •* Platinum-based therapy for locally advanced or metastatic disease, given in combination or sequentially with anti-PD-(L)1 therapy. Participants who received adjuvant platinum-based therapy meet this criterion if disease progression occurred within 6 months from the last dose that the participant received that therapy. No additional cytotoxic therapies after progression on platinum-based therapy are allowed
• •* Prior best overall response of stable disease or better with anti-PD-(L)1 therapy
• •* Disease progression must have occurred while the participant has been receiving anti-PD-(L)1 therapy or within 16 weeks of the last dose of anti-PD-(L)1 therapy
• •Participants with Measurable disease per RECIST v1.1
• •Participants with Eastern Cooperative Oncology Group (ECOG) PS 0 or 1
• •Adequate hematological, hepatic, and renal function as defined in the protocol.
• •Phase 2a part only: central liquid biopsy analysis of tumor molecular alterations with an assay with appropriate regulatory status