Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations

NCT06517953 | Recruiting Phase 2

• 1 other identifier: A2024-002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer Metastatic; EGFR G719X; EGFR L861Q; EGFR S768I

Outcome Measures

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).

  24 months

Secondary Outcomes (3)

• Progression-free survival（PFS）

  12 months

• Disease control rate（DCR）

  12 months

• Overall survival （OS）

  24 months

Study Arms (1)

Icotinib + Befotertinib

EXPERIMENTAL

orally Icotinib 125mg Tid plus orally Befotertinib 100mg qd until progression disease

Drug: Icotinib; Drug: Befotertinib

Interventions

Icotinib DRUG

An orally first-generation EGFR inhibitior.

Also known as: Conmana

Icotinib + Befotertinib

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.

Also known as: D-0316

Icotinib + Befotertinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Predicted survival ≥ 3 months.
• At least 1 measurable tumor lesion without radiotherapy as per RECIST v1.1.
• Agree to use effective contraception during the study period and for at least 3 months after completion of the study treatment.
• Provision of informed consent prior to any study procedure.

You may not qualify if:

• 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.
• Previous major surgery within 4 weeks before the first dose of study drug,or planing to have major surgery during study.
• Symptoms or signs worsened within 2 weeks before the first dose of study drug.
• Any unresolved toxicities from prior treatment greater than NCI CTCAE v4.03 grade 2 or higher.
• Spinal cord compression,symptomatic or unstable central nervous system (CNS) metastases that require the use of steroids .Patients who have a stable CNS status for at least 4 weeks before treatment will be allowed to join the study.
• Any clinical evidence of serious or uncontrolled systemic disease,including uncontrolled hypertension after drug treatment,active bleeding diatheses, previous or present thrombus,uncontrolled cardiovascular and cerebrovascular diseases.
• Active infection including hepatitis B,hepatitis C,syphilis and human immunodeficiency virus (HIV).
• Mean resting corrected QT interval (QTcF) ≥450 msec,obtained from 3 ECGs or any clinically important abnormalities in rhythm,conduction, morphology of resting ECG or left ventricular ejection fraction (LVEF) ≤ 50%,etc.
• Previous history of interstitial lung disease(ILD),drug-induced interstitial lung disease,history of radiation-induced pneumonia requiring hormone therapy,or clinical evidence of active interstitial lung disease.
• Any instance that affects the patient's ability to swallow drug or oral malabsorption.
• Occur any laboratory indicator abnormalities as follow：
• absolute neutrophil count(ANC)\<1,500/mcL

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

icotinib

Central Study Contacts

Xue Hou, MD

CONTACT

135 7056 9436; houxue@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 24, 2027
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)