Advanced non-small cell lung cancer
Conditions
Interventions
Experimental Group:Longqi Capsules, oral. Take 4 capsules per dose, three times a day. Take after meals, half an hour after eating.
Control Group:Longqi Capsules Simulator, oral administration. Take 4 capsules at a time, 3 times a day. Take after meals, half an hour after eating.
Sponsors
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for non-small cell lung cancer (squamous or non-squamous histological examination is allowed. Mixed tumors will be classified according to the predominant cell type; if small cell or neuroendocrine components are present, eligibility is not met); (2) According to the International Association for the Study of Lung Cancer and the 9th edition of the Union for International Cancer Control TNM staging for lung cancer, patients with stage III B/III C (locally advanced), or stage IV (metastatic or recurrent) disease; (3) Failed standard treatment, unable to tolerate standard treatment, or unwilling to receive standard treatment, but not suitable for or refusing surgery, radiotherapy, chemotherapy, molecular targeted therapy, or immunotherapy; (4) Meets the diagnostic criteria for phlegm and blood stasis obstructing the lung syndrome in traditional Chinese medicine; (5) During the screening/induction period, at least two of the main symptoms of lung cancer [cough, sputum production, dyspnea (shortness of breath), chest tightness] have an average NRS score of 4 or higher; (6) ECOG PS score of 0-2, with an expected survival of =3 months; (7) Age between 18-80 years (inclusive), gender; (8) Informed consent and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Presence of brain metastases or any leptomeningeal disease, except for: 1) Those who have previously received treatment for brain metastases and meet all of the following 3 criteria: a. Only supratentorial and cerebellar metastases, b. Disease must be stable for =4 weeks with no imaging evidence of new or enlarging brain metastases, c. No symptoms of brain metastases, and participants must have discontinued corticosteroids/dehydrating agents for at least 2 weeks prior to initiation of the investigational drug; 2) Those who have not received prior treatment for brain metastases and meet all of the following 4 criteria: a. Only a single isolated lesion, b. Maximum lesion diameter <1 cm, c. Disease must be stable for =4 weeks without neurological symptoms due to brain compression, d. Participants must have discontinued corticosteroids/dehydrating agents for at least 2 weeks prior to initiation of the investigational drug; (2) History or current presence of autoimmune disease or syndrome requiring systemic treatment within the past 2 years (Note: Replacement therapies such as insulin for adrenal or pituitary insufficiency, thyroid hormone, or physiological doses of corticosteroids are not considered systemic therapy); (3) History or current diagnosis of other malignancies within the past 3 years, except for: other malignancies treated with surgery alone and achieving continuous 5-year disease-free survival (DFS); cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading lamina propria)]; (4) Imaging evidence indicating tumor invasion of major blood vessels or ill-defined borders with vessels, OR investigator's judgment that the tumor remains highly likely to invade major vessels after 4 cycles of combination chemotherapy, potentially causing fatal massive hemorrhage (Major thoracic vessels include pulmonary trunk, left pulmonary artery, right pulmonary artery, left pulmonary vein, right pulmonary vein, superior vena cava, inferior vena cava, and aorta); (5) Severe bone damage due to bone metastases, including pathological fractures in weight-bearing bones (e.g., vertebrae, pelvis, femur, tibia, phalanges, calcaneus, etc.) occurring within 6 months or highly likely to occur within 6 months, and spinal cord compression, defined as imaging reports showing weight-bearing bone metastases with bone destruction OR more than three sites of weight-bearing bone metastases; (6) Poorly controlled pleural or peritoneal effusion (requiring drainage at least twice per week); (7) Arterial/venous thrombotic events within 6 months prior to screening, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis, and pulmonary embolism; (8) Gastrointestinal abnormalities: Inability to take oral medication (e.g., inability to swallow, intestinal obstruction, etc.); history of malabsorption syndrome or other conditions that may interfere with gastrointestinal absorption, including prior partial gastrectomy or intestinal resection (excluding appendectomy); treatment for active peptic ulcer disease within the past 6 months; chronic diarrhea of CTCAE grade 2 or higher despite maximal medical therapy; other conditions deemed by the investigator as potentially causing gastrointestinal bleeding or perforation; (9) Severe organic dysfunction of major organs, such as severe ch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main symptoms of lung cancer [cough, sputum production, dyspnea (shortness of breath), chest tightness] NRS(numerical rating scale) total score weekly average decrease compared to baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main symptoms of lung cancer [cough, sputum production, shortness of breath (breathlessness), chest tightness] NRS (numerical rating scale) total score, weekly average score, and decrease from baseline.;Main symptoms of lung cancer [cough, expectoration, dyspnea (breathlessness), chest tightness] improvement rate.;Main symptoms of lung cancer [cough, expectoration, shortness of breath (dyspnea), chest tightness] disappearance time and disappearance rate.;Main symptoms of lung cancer [cough, expectoration, shortness of breath (breathlessness), chest tightness] NRS (numerical rating scale) total maximum score decrease from baseline;Reduction from baseline in the weekly mean NRS (numerical rating scale) score for individual lung cancer symptoms and the improvement rate.;Time and rate of disappearance of individual symptoms in lung cancer.;The change in Traditional Chinese Medicine (TCM) syndrome scores from baseline;Change in scores from baseline for the Quality of Life (QoL) Questionnaires (EORTC QLQ-C30 and EORTC QLQ-LC13);Emergency Medications Usage (including number of users, usage rate, number of uses, and quantity used);Overall Survival (OS);Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactLi Jie
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine
Outcome results
None listed