nonsquamous lung cancer, non-small-cell lung cancer
Conditions
Interventions
Test group:Combination therapy of PD-1/PD-L1 inhibitor +/- pemetrexed +/- carboplatin
Sponsors
Shanghai Geriatric Medical Center
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form (ICF); 2. Age >= 70 years; 3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC), staged as unresectable locally advanced (IIIb/IIIc) or metastatic (IV); 4. Absence of EGFR or ALK gene mutations; 5. No prior systemic anti-tumor therapy. 6. At least one measurable lesion according to RECIST 1.1 criteria. 7. ECOG performance status of 0-1 and an expected survival time of >=3 months; 8. Adequate organ function as confirmed by laboratory tests within 28 days prior to the first dose of study medication;
Exclusion criteria
Exclusion criteria: 1. Has received systemic anti-tumor therapy previously; 2. Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Has received antineoplastic biology therapy; 3. Has active autoimmune disease; 4. Is on chronic systemic steroids (>10 mg/day),or use of immunosuppressive drugs within 14 days prior to the first dose; 5. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of study of medication; 6. Has severe cardiovascular diseases; 7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. Has known history of Human Immunodeficiency Virus (HIV); 9. Has known active Hepatitis B(HbsAg(+)and HBV-DNA>=10^3copies/ml) or active Hepatitis C(anti-HCV(+),HCV-DNA(+),need antiviral treatment); 10. Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb); 11. Has diseases or laboratory abnormalities that would interfere with cooperation with the requirements of the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;objective response rate;disease control rate;Duration of relief; | — |
Countries
China
Contacts
Public ContactJie Hu
Shanghai Geriatric Medical Center
Outcome results
None listed