SMARCA4 Deletion of advanced or metastatic non-small cell lung cancer
Conditions
Interventions
Treatment group:iparomlimab and tuvonralimab combined with platinum-based chemotherapy and Anlotinib
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join this study and sign the informed consent form; 2. Age 18-75 years old, gender is not limited; 3. Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer; 4.SMARCA4 mutations; 5. No other susceptible mutations (including EGFR, ALK, ROS1, RET, c-Met, HER2, BRAF genes); 6. At least one measurable lesion according to RECIST1.1 criteria; 7. ECOG score 0-1; 8. No prior chemotherapy or other systemic therapy, adjuvant or neoadjuvant platinum-containing chemotherapy that has progressed 6 months > 6 months after the end of the last treatment is allowed to be enrolled; 9. Life expectancy>3 months; 10. Adequate organ and bone marrow function: (1) Routine blood examination; a) Hemoglobin (HGB) >=90g/L; b) Absolute neutrophil count (ANC) >=1.5×10^9/L; c) Platelet count (PLT) >=100×10^9/L; (2) Blood biochemical examination; d) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5× upper limit of normal (ULN) (or <=5×ULN if liver metastases are present); e) total bilirubin (TBIL) < = 1.5×ULN; f) serum creatinine (Cr) < = 1.5× ULN or creatinine clearance (CCr) =45 mL/min (Cockcroft-Gault formula); g) APTT<=1.5×ULN with concomitant INR or PT<=1.5×ULN (not receiving anticoagulation); 11. Women of childbearing potential must have a negative pregnancy test (serum or urine) result within 14 days prior to enrollment and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of study drug; For males, should be surgically sterile or agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last administration of study drug; 12. Willing and able to undergo follow-up until death or end of the study or termination of the study.
Exclusion criteria
Exclusion criteria: 1.Histologically or pathologically confirmed mixed small cell lung cancer, sarcomatoid carcinoma, or neuroendocrine tumor; 2.Central nervous system (CNS) metastases, history of leptomeningeal metastasis, or current leptomeningeal metastasis; 3.Concurrent malignancies within =10 mg prednisolone equivalent daily) or other immunosuppressive therapy within 14 days prior to the first dose of epacadostat/ivolumab. 7.HIV-positive or diagnosed with acquired immunodeficiency syndrome (AIDS); 8.Active hepatitis B or hepatitis C infection; 9.Active bleeding before treatment; 10.Interstitial lung disease or non-infectious pneumonitis; 11.Severe cardiac, pulmonary, hepatic, or renal dysfunction. 12.Severe infection requiring intravenous antibiotics, antifungals, or antivirals within 4 weeks prior to treatment, or unexplained fever >38.5°C during screening/before the first dose; 13.Hypersensitivity or allergic reaction to any component of the study treatment; 14.Pregnant or breastfeeding women; 15.History of uncontrolled psychiatric disorders or substance abuse; 16.Arterial or venous thrombotic events within 3 months prior to treatment; 17.Other conditions deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate(ORR);overall survival(OS);Duration of response(DoR);disease control rate (DCR);Safety; | — |
Countries
China
Contacts
Public ContactWang Haiyong
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed