Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental group:Formulate anti-tumor regimens based on a practical geriatric assessment tool: For the low-risk group, a platinum-based doublet chemotherapy combined with immunotherapy is administer
for the intermediate-risk group, single-agent chemotherapy combined with immunotherapy is given
and for the high-risk group, single-agent immunotherapy is provided.
Control group:Formulate the regimen based on the conventional age and PS score: For patients with an age = 75 years old and a PS score = 1, administer a platinum-based doublet chemotherapy combined wi
for patients with an age > 75 years old or a PS score of 2, administer single-agent chemotherapy combined with immunotherapy. Based on the pathological type, for patients with non-squamous cell carcin
for patients with squamous cell carcinoma, administer taxanes ± platinum.
Sponsors
Beijing hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The age of the included patients is 65 years old and above; 2. NSCLC patients who are histologically or cytologically confirmed to be ineligible for surgical treatment and radical concurrent chemoradiotherapy, with locally advanced or metastatic disease (stage IIIB, IIIC or IVA, IVB according to the 9th edition of AJCC staging); 3. There are no driver gene alterations (EGFR, ALK, ROS1) confirmed by histological molecular testing; 4. The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0-2; 5. The patients have not received any systemic anti-tumor treatment for locally advanced/metastatic disease previously; 6.The expected survival time is more than 3 months; 7.The investigator confirms that there is at least one measurable lesion according to the RECIST 1.1 criteria.
Exclusion criteria
Exclusion criteria: 1. Patients with active brain metastases (except for those with asymptomatic brain metastases or those whose brain metastases have remained stable for at least 2 weeks after treatment). 2. Patients who have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137); 3. Patients who have used immunosuppressive drugs within 14 days before the first use of the PD-1 inhibitor, excluding intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg/day of prednisolone or other corticosteroids at an equivalent physiological dose); 4. Patients with active autoimmune diseases or immunodeficiency, or with a history of the above conditions, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, etc., shall not be included; 5. Patients who have had severe infections within 4 weeks before the first administration (e.g., requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or who have had unexplained fever > 38.5°C during the screening period/before the first administration; 6. Patients who have received live attenuated vaccines within 30 days before the first administration or are expected to receive them during the study period; 7. Untreated active hepatitis B, hepatitis C (positive for hepatitis C antibody and HCV-RNA higher than the lower limit of detection of the analytical method), or co-infection with hepatitis B and hepatitis C; Note: Hepatitis B subjects who meet the following criteria are also eligible for inclusion: The HBV viral load must be < 1000 copies/ml (200 IU/ml) before the first administration, and the subject should receive anti-HBV treatment during the entire study period of chemotherapy drugs to avoid viral reactivation. For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is needed; 8. Patients with a clear history of allergy, known to have allergic reactions to the active ingredients of the PD-1 inhibitor and the planned chemotherapy drugs and/or any excipients; 9. Other conditions that, in the judgment of the investigator, may render the patient unfit for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of adverse events of grade 3 and above that occur within 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence rate of adverse events of all grades;Progression-Free Survival;Overall Survival;Quality of life; | — |
Countries
China
Contacts
Public ContactLin Li
Beijing hospital
Outcome results
None listed