Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

This research study aims to explore the combination of two targeted drugs as first-line treatment for Non-Small Cell Lung Cancer (NSCLC) with uncommon EGFR mutation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older.

Pathologically confirmed adenocarcinoma of the lung, with locally advanced or metastatic disease and not amenable to curative surgery or radiotherapy (stage IIIB, IIIC or IV disease based on the eighth edition of the American Joint Committee on Cancer (AJCC) TNM classification). Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.

Patients must be treatment-naive for locally advanced or metastatic NSCLC systemic antitumor therapy. Prior adjuvant and neo-adjuvant therapy (except for EGFR-TKIs) is permitted if have been completed at least 6 months prior to initiation of disease progression.

Tissue or blood samples are confirmed by the central laboratory or research center as rare EGFR mutations, including exon 18 G719X, S768I in exon 20 and at least one of the L861Q mutations in exon 21;

Disqualifiers

Combined with other malignancy(except for clinically cured in situ cervix carcinoma, basal cell or squamous epithelial skin cancer,thyroid papillary carcinoma).

Prior treatment with any EGFR-TKIs.

Prior treatment with any systemic antitumor therapy for locally advanced or metastatic NSCLC.

Previous traditional chinese medicine with an antitumor indication within 2 weeks before the first dose of study drug.

Trial design

Design model

Single group

Treatments tested in this trial

  • Icotinib

    Drug

    An orally first-generation EGFR inhibitior.

  • Befotertinib

    Drug

    An orally available, irreversible, third-generation,mutant-selective epidermal growth factor receptor(EGFR)inhibitor. Befotertinib combine with icotinib means that both drugs will be given together until disease progression or meet the discontinuation criteria.

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: Icotinib + BefotertinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

ORR, per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).

Time frame
24 months

Secondary outcomes

1

Progression-free survival(PFS)

PFS, defined as time from study drug administration to progression or death due to any cause.

Time frame
12 months
2

Disease control rate(DCR)

DCR, defined as proportion of complete response, partial response, and disease stabilization to the proportion of patients with evalueable tumors.

Time frame
12 months
3

Overall survival (OS)

OS, defined as the time from study drug administration until the date of death due to any cause.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Sun Yat-Sen University Cancer Center

Sponsor institution