Lung cancer
Conditions
Interventions
Intervention group:All-trans retinoic acid: For oral administration, it is recommended to administer the drug at a fixed time every day, with a dosage of 20mg three times a day (tid). Continuous admi
Paclitaxel, intravenous injection (IV), at a dose of 175mg/m2, on Day 1 of each cycle.
(2) Carboplatin, intravenous injection (IV), with an area under the curve (AUC) of 4 - 5, on Day 1 of each cycle
Albumin-bound paclitaxel, intravenous injection (IV), at a dose of 260mg/m2, on Day 1 of each cycle.
(3) Carboplatin, intravenous injection (IV), with an area under the curve (AUC) of 4 - 5, on Day 1
Pemetrexed, intravenous injection (IV), at a dose of 500mg/m2, on Day 1 of each cycle.
If patients cannot tolerate carboplatin, cisplatin at a dose of 75mg/m2, intravenous injection (IV), on Day 8 of
Sponsors
Cancer Hospital,Chinese Academy of Medical Sciences.
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in this study: (1) Aged 18 years or older, with histologically confirmed stage II - IIIB [T3, N2] non-small cell lung cancer (according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system), and assessed as resectable. (2) Having never received previous systemic treatment. (3) With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1. (4) Having at least one measurable lesion that meets the criteria of the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. (5) With an expected survival period of >= 3 months. (6) Screening laboratory parameters should be obtained within 7 days prior to enrollment and must meet the following criteria: 1) Criteria for routine blood tests (without blood transfusion within 14 days): a. Hemoglobin (HB) >= 90 g/L; b. Absolute neutrophil count (ANC) >= 1.5 × 10?/L; c. Platelet count (PLT) >= 80 × 10?/L. 2) Biochemical tests should meet the following criteria: a. Total bilirubin (TBIL) = 50 ml/min. 3) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >= 50%. (7) With good compliance and voluntarily signing a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects will not be eligible for enrollment in this study if they meet any one of the following criteria: (1) Having driver gene mutations such as EGFR, ALK, BRAF, ROS1, etc. detected by genetic testing and there are clinically relevant targeted therapeutic drugs available. (2) Having a pathological mixture with small cell lung cancer components. (3) Having interstitial lung disease, severely impaired lung function, severe pulmonary fibrosis, radiation pneumonitis, a history of drug-induced lung disease, and evidence of active pulmonary inflammation indicated by the results of chest CT examination during the screening period. (4) Patients who have previously received treatment with PD-1 inhibitors, CTLA-4 inhibitors, or any other antibodies or drugs specifically targeting T cell co-stimulation or immune checkpoint pathways. (5) Patients with any severe and/or uncontrolled diseases, including: 1) Patients with poorly controlled blood pressure (systolic blood pressure >=150 mmHg, diastolic blood pressure >= 100 mmHg); 2) Patients with myocardial ischemia above grade I or myocardial infarction, arrhythmia (including QTc >= 480 ms), and = grade 2 congestive heart failure (classified by the New York Heart Association (NYHA)); 3) Patients with active or uncontrolled severe infections (>= grade 2 infection according to the Common Terminology Criteria for Adverse Events (CTC AE)); 4) Patients with liver cirrhosis, decompensated liver disease, active hepatitis, chronic hepatitis B with hepatitis B virus (HBV)-DNA quantitative titer greater than 2000 IU/mL, and active hepatitis C with positive hepatitis C virus (HCV) RNA; 5) Patients with renal failure requiring hemodialysis or peritoneal dialysis. (6) Patients with active, known or suspected autoimmune diseases. However, patients with type 1 diabetes, hypothyroidism requiring only hormone replacement, skin diseases not requiring systemic treatment (such as vitiligo, psoriasis or alopecia), or those that are not expected to relapse without external triggers are allowed to be enrolled. (7) Immunocompromised patients, including patients known to be human immunodeficiency virus (HIV) seropositive, due to the increased risk of fatal infections when receiving myelosuppressive treatment. (8) Patients with a history of organ transplantation or those preparing to receive organ transplantation. (9) Patients who require systemic treatment with corticosteroids (more than 10 mg of prednisone equivalent per day) or other immunosuppressive drugs within 14 days prior to treatment. Inhaled or topical steroids, as well as adrenal replacement steroids with a daily dose greater than 10 mg of prednisone equivalent, are allowed in the absence of active autoimmune diseases. (10) Patients with a history of malignant tumors (except for fully treated basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ, superficial bladder cancer, prostate carcinoma in situ, breast carcinoma in situ), unless radical treatment has been performed and there is no evidence of recurrence or metastasis within the recent 5 years. (11) Pregnant or lactating women; Women of childbearing age who are unwilling or unable to use effective contraceptive methods throughout the treatment period of this trial and within 12 weeks after the last administration of the trial drug [Women of childbearing age include: any woman who has experienced menarche and has not undergone successful artificial sterilization procedures (hysterectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate;Disease - free Survival;2 - year Event - Free Survival Rate;Overall Survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactTan Fengwei
Cancer Hospital,Chinese Academy of Medical Sciences.
Outcome results
None listed