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

Phase 1

Recruiting

• Conditions: on-Squamous Non-Small Cell Lung Cancer; Therapeutic area: Not possible to specify

• Registration Number: CTIS2022-502010-85-00
• Lead Sponsor: Merck Healthcare KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-08
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Are = 18 years of age at the time of signing the informed consent, Are diagnosed with nsqNSCLC histologically or cytologically confirmed, Radiologically confirmed/documented disease progression during or after the following systemic therapies (all required): •a.At most, 1 line of anti-PD-(L)1 therapy for locally advanced or metastatic disease. Note 1: 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. Note 2: this includes (neo)adjuvant anti-PD-(L)1 therapy for locally advanced disease, provided disease progression occurs within 16 weeks of the last dose of anti-PD-(L)1 therapy. •b.Platinum-based therapy for locally advanced or metastatic disease, given in combination or sequentially with anti-PD-(L)1 therapy. Participants who received (neo)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 •c.Prior best overall response of stable disease or better with anti-PD-(L)1 therapy •d. 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, Measurable disease per RECIST v1.1, as assessed by the Investigator, ECOG PS 0 or 1, Adequate hematological, hepatic and renal function as defined in the protocol., Archival FFPE tumor tissue is available or tumor genomic profiling with a NGS based test performed in a certified laboratory and PD-L1 status as determined by an assay of appropriate regulatory status are required., Phase 2a part only: central liquid biopsy analysis of tumor molecular alterations with an assay with appropriate regulatory status. Participants will be allocated to Stratum A, B and C as defined in the protocol., Other protocol defined inclusion criteria could apply

Exclusion Criteria

Participants with tumors harboring actionable EGFR or ALK genomic aberrations. Participants with tumors with other actionable aberrations are eligible and allowed to have received up to 1 line of available targeted therapy, History of additional malignancy within 3 years before the date of enrollment. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor’s Medical Monitor, is considered cured with minimal risk of recurrence within 3 years, Known brain metastases, unless clinically stable, history of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease, Other protocol defined inclusion criteria could apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified