M1774 in Combination with Cemiplimab in Participants with Non-Squamous NSCLC (DDRiver NSCLC 322)
- Conditions
- on-Squamous Non-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2031230332
- Lead Sponsor
- Ishii Kyoko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Are diagnosed with nsqNSCLC histologically or cytologically confirmed
-Radiologically confirmed/documented disease progression during or after the following systemic therapies
-Measurable disease per RECIST v1.1, as assessed by the Investigator
-ECOG PS 0 or 1
-Adequate hematologic function
-Adequate hepatic function
-Adequate renal function
-Archival FFPE tumor tissue is 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 1 of the strata as follows:
- STK11 and/or KEAP1 loss of function mutation: Stratum A
- ATM, ARID1A, SMARCA4, or PBRM1 loss of function mutation: Stratum B
- Other or nonidentified alterations: Stratum C
- Other protocol defined inclusion criteria could apply
- Participants with tumors harboring actionable EGFR or ALK genomic aberrations as determined by local assessment with assays of appropriate regulatory status
- History of additional malignancy within 3 years before the date of enrollment
- Known brain metastase
- Active and/or uncontrolled infection
- Organ transplantation, including allogeneic stem cell transplant
- Uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification >= Class III), uncontrolled cardiac arrhythmia, calculated QTc average using the QTcF > 470 msec; unstable angina pectoris, myocardial infarction or a coronary revascularization procedure, cerebral vascular accident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start
- History of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease
- Any other clinical condition, uncontrolled concurrent illness, or other situations, which in the Investigator's opinion would not make the patient a good candidate for the study or may potentially impact the absorption of M1774 such as (but not limited to) significant small bowel resection, gastric surgery, or exocrine pancreatic insufficiency requiring pancreatic enzyme replacement therapy
- Prior use of ATR, CHK1, and WEE1 inhibitors
- Prohibited concomitant therapy
- Live vaccines within 4 weeks of first dose of study intervention and while receiving study intervention
- Active or history of autoimmune disease that has required chronic systemic immunosuppressive therapy (including but not limited to corticosteroids [e.g. prednisone > 10 mg/day] or equivalent), that might deteriorate when receiving immunostimulatory agent, or history of irAE Grade >= 3 or any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 therapy.
- Participants who received prior chemotherapy, biological therapy (e.g. antibodies) or systemic immunostimulatory agents (e.g. interferon and interleukin 2) within 4 weeks (6 weeks for nitrosurea, mitomycin-C), or who have been treated with small molecule therapeutics or any investigational agents within 4 weeks prior to starting study interventions, or within 5 half-lives, whichever is shorter
- Prior radiotherapy within 14 days before the first dose of study intervention or prior lung radiotherapy of > 30 Gy within 12 weeks before the first dose of study intervention
- Persistence of AEs related to any prior treatments that have not recovered to Grade <= 1
- Other protocol defined exclusion criteria could apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [Phase 1b]<br>- Confirmed OR according to RECIST 1.1 as assessed by Investigator<br>- Occurrence of AEs and treatment-related AEs<br>[Phase 2a]<br>- Confirmed OR according to RECIST 1.1 as assessed by Investigator
- Secondary Outcome Measures
Name Time Method