Carcinoma Clinical Trial
— SELECT-2Official title:
Synergistic Real-World Study and Evidence-based Medicine Evaluation of Elemene Combined With Tyrosine Kinase Inhibitors(TKIs)in the Treatment of Advanced Non-small Cell Lung Cancer (NSCLC): Prospective Study
This is a nationwide, multicenter and prospective cohort study. The purpose of this study is to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer.
Status | Recruiting |
Enrollment | 744 |
Est. completion date | March 30, 2026 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age = 18. 2. Histologically or cytologically confirmed advanced non-small cell lung adenocarcinoma(stage IIIB~IV). 3. Patients with EGFR mutations (deletions in exon 19 and L858R in exon 21 of the EGFR gene), plan to receive First-generation EGFR-TKIs (Gefitinib, Erlotinib, Icotinib) or third generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib) monotherapy for the first time (patients who have been using first- or third-generation EGFR-TKIs for less than 28 days can be enrolled). 4. Patients positive for EGFR gene mutation (deletions in exon 19 and L858R in exon 21 of the EGFR gene), with disease progression after receiving chemotherapy can be enrolled. 5. Confirmed by investigators, tumor tissue can't be surgically excised. 6. No prior exposure to elemene injectable and/or oral emulsion within one month. 7. Prior exposure to other Chinese patent medicine with similar efficacy within one month. If more than one month, patients can be enrolled after a 30-day washout period (without continuing to use the above medications). 8. The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document. Exclusion Criteria: 1. Patients with any EGFR mutations other than 19DEL or 21L858R. 2. Accompanied by other active tumors. (Except for stable basal cell carcinoma after treatment, If metachronous tumors have been controlled, participating was allowed ) 3. Exposure to First- or third-generation EGFR-TKIs combined treatment, for example, chemotherapy, anti-angiogenesis therapy. 4. Receiving radiotherapy or chemotherapy. 5. Pregnant or lactating women. 6. Allergic to Elemene. 7. Participating in other drug clinical trials. 8. Refuse to comply with the follow-up. 9. The researchers did not consider it appropriate to participate in this study for other reasons. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Cancer Hospital | Beijing | |
China | Sichuan Academy of Medical Sciences· Sichuan Province People's Hospital | Chengdu | Sichuan |
China | Hangzhou Cancer Hospital | Hangzhou | Zhejiang |
China | The Second People's Hospital of Yangcheng County | Jincheng | Shanxi |
China | Affiliated Hospital of Nantong University | Nantong | Jiangsu |
China | Panjin Central Hospital | Panjin | Liaoning |
China | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Tian Xie | LinkDoc Technology (Beijing) Co. Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of life (QOL) | Quality of Life (QOL) was measured using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13). | Start of treatment until 1-year follow-up | |
Other | Karnofsky Performance Scale (KPS) | KPS: Performance status were measured using Karnofsky Performance Scale (KPS) | Start of treatment until 1-year follow-up | |
Other | Traditional Chinese Medical(TCM) symptoms score | TCM symptom score: Traditional Chinese Medical symptoms were measured from these eight aspects: chest pain, oppression in the chest, blood stasis, shortness of breath, weakness, palpitations, dry mouth, vexation. Particular attention should be paid to chest pain and weakness. | Start of treatment until 1-year follow-up | |
Other | Molecular biomarkers | Including but not limited to drug-resistant genes and circulating tumor cells. Such as PD-L1?MSI-H/dMMR?TMB?HLA?POLE?POLD1?DDR?TP53?KRAS?BRCA2?PBRM1?MDM2/4?EGFR?ALK?PTEN?JAK1/2?DNMT3A?STK11. | Start of treatment until 1-year follow-up | |
Primary | PFS | PFS was defined as the interval from the date of randomization to the date of the first evidence of disease progression or death, whichever occurs first. Disease progression was defined according to RECIST 1.1. | Start of treatment until 1-year follow-up | |
Secondary | ORR | ORR was defined as the percentage of participants with the best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST 1.1. | Start of treatment until 1-year follow-up | |
Secondary | DCR | Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1. | Start of treatment until 1-year follow-up | |
Secondary | OS | Overall survival (OS) was defined as the interval from the date of randomization to date of death from any cause, or the date of last known follow-up alive. | Start of treatment until 1-year follow-up | |
Secondary | Incidence and severity of AE or SAE | Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect |
Start of treatment until 30 days after the last treatment | |
Secondary | Incidence and severity of ADR or SADR | All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.
A SADR is a serious ADR according to the above criteria of SAE. |
Start of treatment until 30 days after the last treatment |
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