Befotertinib and Icotinib in Treatment-naive Patients With Advanced EGFR-Mutant Lung Cancer

NCT05007938 | Active Not Recruiting Phase 2

• 1 other identifier: BD-BF-IV01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying a combination of two drugs as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.

Conditions

Non-Small Cell Lung Cancer

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 (6)

• Duration of response（DOR）

  24 months

• Disease control rate（DCR）

  24 months

• Progression-free survival（PFS）

  36 months

• Intracranial objective response rate（iORR）

  24 months

• Overall survival （OS）

  36 months

Other Outcomes (4)

• AUC

  4 months

• Tmax

  4 months

• Cmax

  4 months

Study Arms (1)

Icotinib + Befotertinib

EXPERIMENTAL

* Icotinib（125 mg orally, three times daily） * Befotertinib（25 mg orally, three times daily）

Drug: Icotinib; Drug: Befotertinib

Interventions

Icotinib DRUG

Icotinib is a EGFR ihibitior.

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.
• The tumour tissues harbour one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R),either alone or in combination with other EGFR mutations, excluding co-mutation of Ex19del and L858R,assessed by central laboratory.
• 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

• Betta Pharmaceuticals Co., Ltd.: lead
• The First Affiliated Hospital of Xiamen University: collaborator

Study Sites (1)

Feng Ye

Xiamen, Fujian, 361003, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Feng Ye, MD

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: August 17, 2021
• Study Start: August 12, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

CN (1)