Non-small cell lung cancer
Conditions
Interventions
A group:Non-squamous cell carcinoma: sintilimab 200mg+ pemetrexed 500mg/m2+ cisplatin 75mg/m2, iv, Q3W, after 4 to 6 cycles, sintilimab 200mg+ pemetrexed 500mg/m2 maintenance therapy
Squamous cell carcinoma: sintilimab 200mg+ paclitaxel 175mg/m2+ carboplatin AUC5, iv, Q3W, after 4-6 cycles, sintilimab 200mg maintenance therapy
B group:osimertinib, 80mg, po, qd
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Signed informed consent; 2)Age range:=18 years old and =75 years old; 3)Histologically or cytologically confirmed locally advanced (IIIB-IIIC),metastatic or recurrent (stage IV) NSCLC,which is inoperable for surgical treatment and radical concurrent radiotherapy and chemotherapy;patients have not previously received systemic therapy; 4)EGFR sensitive mutations (Ex19del,L858R); 5)PD-L1 TPS=50%; 6)According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there is at least one radiographically measurable lesion; 7)Patients have not previously received any systemic antitumor therapy for advanced/metastatic disease; 8)Patients with brain metastases who are asymptomatic or whose symptoms are stable after local treatment; 9)The patient is allowed to receive palliative radiation therapy,provided that the radiation therapy ends at least 1 week before the first dose and that the radiation-related toxicity returns to less than or equal to 1 degree (except for hair loss). 10)ECOG score 0-1; 11)Expected lifespan: >3 months; 12)Adequate organ function:ANC=1.5x109/L;Platelet=100×109/L; Hemoglobin>9g/dL;Total bilirubin=1.5 times ULN; AST,ALT=2.5 times ULN;Serum creatinine=1.5 times ULN and creatinine clearance =60 ml/min;INR or PT=1.5 times ULN;TSH is in the normal range;Myocardial enzyme spectra are in the normal range; 13)Female patients of reproductive age who underwent a urine or serum pregnancy test within 3 days prior to receiving the initial study drug administration and the results were negative.
Exclusion criteria
Exclusion criteria: 1) Small cell lung cancer (SCLC), including SCLC and NSCLC mixed lung cancer; 2) Received radiation therapy before drug administration,meeting one of the following conditions: =30% of bone marrow received radiation therapy within 14 days prior to treatment; Received radiotherapy for lung lesions within 6 weeks prior to treatment with a dose >30Gy; The end time of palliative radiotherapy was within 7 days before the first study drug administration; 3) Diagnosis of malignant diseases other than NSCLC within 5 years prior to the first dose; 4) Currently participating in interventional clinical research treatment; 5) Previous treatment with anti-PD-1,anti-PD-L1,or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors; 6) Previously received EGFR-TKI treatment; 7) Currently receiving drugs or herbal supplements known to be effective inducers of cytochrome P450 (CYP) 3A4; 8) Received large and medium-sized surgery within 4 weeks before the first administration; 9)Received proprietary Chinese medicines with anti-lung cancer indications or immunomodulatory drugs within 2 weeks before the first administration; 10) An active autoimmune disease requiring systemic treatment has occurred within 2 years prior to initial administration; 11) Receiving systemic glucocorticoid therapy within 7 days prior to the first administration of the study; 12) Clinically uncontrollable pleural effusion/abdominal effusion; 13) Known allogeneic organ transplantation (other than corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 14) Those who are known to be allergic to the active ingredients or excipients of the drug in this study, such as sintilimab, pemetrexed, cisplatin, and osimertinib; 15) Refractory nausea and vomiting,chronic gastrointestinal disorders,inability to swallow preparations; 16) Patients have not fully recovered from toxicity and/or complications caused by any intervention before starting treatment; 17) Known history of human immunodeficiency virus (HIV) infection; 18) Untreated active hepatitis B; 19) Active HCV-infected patients; 20) Received live vaccine within 30 days prior to the first dose (cycle 1,day 1); 21) Pregnant or lactating women; 22) The presence of any serious or uncontrolled systemic disease; 23) Medical history or evidence of disease that may interfere with the test results, prevent participants from fully participating in the study,abnormal treatment or laboratory test values,or other conditions that the investigator considers unsuitable for enrollmen;the investigator considers other potential risks unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rates;duration of response;overall survival;adverse event;serious adverse event; | — |
Countries
China
Contacts
Public ContactKe Wang
West China Hospital, Sichuan University
Outcome results
None listed