Lung Cancer
Conditions
Interventions
Trial group:Pembrolizumab + chemotherapy (squamous cell carcinoma: albumin paclitaxel + carboplatin / adenocarcinoma: pemetrexed + carboplatin) + celecoxib
Control group:Pembrolizumab + chemotherapy (squamous cell carcinoma: albumin paclitaxel + carboplatin / adenocarcinoma: pemetrexed + carboplatin)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Written informed consent, willing and able to comply with the trial protocol during the trial, including all treatment methods and planned laboratory tests. (2) Men or women over 18 years old and under 75 years old. (3) Locally advanced (IIIb) or metastatic (IV) non-small cell lung cancer confirmed histologically as incurable surgery or radiotherapy, with at least one measurable lesion. (4) The patient must be able to provide fresh or archived tumor tissue and its pathology report. (5) The ECOG score is 0 or 1. (6) Have not received anti-tumor therapy in the past, and the life expectancy is not less than 12 weeks. (7) The main organ functions are basically normal: a. Adequate liver function: AST and ALT 50ml/min. c. Sufficient bone marrow function: Hb >= 100g/L, absolute neutrophil count >= 1.5 x 10^9/L, platelet >= 100 x 10^9/L. d. International normalized ratio (INR) or prothrombin time (PT) <= 1.5x ULN, spark partial thromboplastin time (APTT) <= 1.5 x ULN.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with sensitive mutations in EGFR, ALK, and ROS1 genes. (2) Previously received immunotherapy, targeted therapy, and vaccine therapy. (3) Suffered from other active malignant tumors in the last 2 years, except for the specific cancers being studied in this study and locally recurring cancers that have been cured (eg, skin basal cell carcinoma; cervical carcinoma in situ, superficial bladder cancer). (4) Contraindications to celecoxib, including allergy to celecoxib (for example, patients who are known to be allergic to sulfonamides, NSAIDS drugs are known to induce asthma, measles or other allergic reactions), active peptic ulcers /Bleeding patients. (5) Severe cardiovascular disease, including myocardial infarction, acute coronary syndrome or history of coronary angioplasty/stent/bypass graft in the last 6 months, or clinically obvious congestive heart failure. A cerebrovascular accident occurred in the last 6 months. Symptomatic pulmonary embolism occurred in the last 28 days. (6) The researcher believes that any other serious or unstable previous medical conditions (except for the above malignant exceptions), mental illness or other conditions that may interfere with patient safety, obtain informed consent or comply with research procedures. (7) Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (Laboratory evidence showing cleared or chronic (ineffective) HBV and HCV infection is allowed patient). (8) Patients with active, known or suspected autoimmune diseases. Type 1 diabetes, hypothyroidism only requires hormone replacement, patients with skin or rheumatic diseases (such as vitiligo, psoriasis, rheumatoid arthritis or hair loss) do not need systemic treatment, or will not recur without external triggers Circumstances will be allowed to sign up. It is acceptable to treat ulcerative colitis and other autoimmune diseases that have been clearly treated (such as total colectomy), but should be discussed with PI. (9) Patients who need to be treated with corticosteroids (daily prednisone equivalent> 10 mg) or other immunosuppressive drugs within 14 days after study drug administration. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal replacement steroid doses are allowed. (10) Interstitial lung disease, pneumonia, or uncontrolled systemic diseases such as diabetes, hypertension, pulmonary fibrosis, etc. (11) Patients who cannot swallow oral medications and patients with gastrointestinal diseases that may interfere with the absorption of test drugs. (12) Women who are pregnant or breastfeeding. (13) Active infections require systemic treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;PFS;Side-effect; | — |
Countries
China
Contacts
Public ContactLi Lu
West China Hospital, Sichuan University
Outcome results
None listed