Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT04401059
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04401059
Study Brief:
Protocol Section:
NCT04401059