Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Prospective Study

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tian Xie
• Collaborator: LinkDoc Technology (Beijing) Co. Ltd.
• Treatments: Gefitinib

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) monotherapy for the first time.

4. Patients positive for EGFR gene mutation, 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).

7. The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document.

Exclusion Criteria:

1. Accompanied by other active tumors. (Except for stable basal cell carcinoma after treatment， If metachronous tumors have been controlled, participating was allowed )

2. Exposure to First-generation EGFR-TKIs combined treatment, for example, chemotherapy, anti-angiogenesis therapy.

3. Receiving radiotherapy or chemotherapy.

4. Pregnant or lactating women.

5. Allergic to Elemene.

6. Participating in other drug clinical trials.

7. Refuse to comply with the follow-up.

8. The researchers did not consider it appropriate to participate in this study for other reasons.