non-small cell lung cancer
Conditions
Interventions
(Stage Ia)z:Gumetininib: Level 1: 200 mg, day 1
Level 2: 250 mg, day 1
Level 3: 300 mg, day 1
Pemetrexed: 500 mg/m^2, day 1
Carboplatin: AUC=5, day 1
Experimental group (Stage Ib):Gumetinib: Determine the phase Ib dose level based on the results of the phase Ia study, day 1
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age>18 years old and =50% of tumor cells stained strongly); 5. No previous systemic anti-tumor therapy, including chemotherapy, targeted therapy, biological therapy, immunotherapy, immunomodulatory drugs, Chinese herbal or proprietary Chinese medicines, and other investigational drugs to control tumors; 6. ECOG PS 0~1; 7. At least one measurable lesion according to RECIST 1.1 criteria; 8. Normal function of bone marrow and other organs: (1) Hematology examination: no obvious signs of hematological diseases, absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count (PLT) >=75×10^9/L, hemoglobin (Hb) > before enrollment =90 g/L; Patients whose hematological indexes are at the critical value and cannot meet the above criteria will be enrolled by the investigator according to the patient's physical condition; (2) Coagulation function tests: international normalized ratio (INR) =3 months.
Exclusion criteria
Exclusion criteria: 1. History or current presence of other malignant tumors (except non-melanoma skin cancer, carcinoma in situ of the breast or cervix, and superficial bladder cancer that have been effectively controlled in the past 5 years); 2. Presence of meningeal metastasis, spinal cord compression, or untreated active brain metastasis; 3. Interstitial lung disease (ILD) or drug-induced interstitial pneumonia, non-infectious pneumonia, including radiation pneumonitis, pulmonary fibrosis, or acute lung disease requiring steroid treatment; 4. Inability to swallow oral medications, active gastrointestinal disease, or major gastrointestinal surgery that, in the investigator's opinion, would affect the administration and absorption of gomeitinib (e.g., active ulcers, uncontrollable diarrhea, or small bowel resection); 5. Presence of = Grade 2 edema or lymphedema not alleviated by clinical intervention; 6. Any severe or uncontrolled comorbid or systemic disease requiring treatment, including severe pleural/abdominal effusion, malignant pleural effusion, hypertension (blood pressure >=150/95 mmHg after medication), active bleeding, active viral infection, including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) infection, as well as any other active bacterial, fungal, or viral infections requiring systemic treatment within 14 days before first dosing; 7. Severe or uncontrolled cardiovascular disease requiring treatment within 6 months prior to enrollment; 8. Lactating or pregnant women, any female of childbearing potential with a positive blood pregnancy test within 7 days before participating in the trial, or any male or female of childbearing potential who refuses to use effective contraception throughout the trial and for 6 months after the last dose; 9. Known allergy or hypersensitivity to any study drug, or other significant allergy history; 10. Other patients deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence and severity of dose-limiting toxicity (DLT);Disease control rate;Progression-free survival;Overall survival;Incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactPanwen Tian
West China Hospital of Sichuan University
Outcome results
None listed