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Befotertinib and Icotinib in Treatment-naive Patients With Advanced EGFR-Mutant Lung Cancer | Clinical Trials | Clareo Health

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

A Phase II, Single Arm, Study to Assess Befotertinib and Icotinib as First-Line Treatment in Patients With Locally Advanced or Metastatic NSCLC and Sensitising EGFR Mutation

NCT05007938•Betta Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Detailed Description

This is a phase II, single-arm study assessing the safety and efficacy of befotertinib (25mg three times daily, orally）combining with icotinib (125mg three times daily, orally) in patients with locally advanced or metastatic NSCLC that is known to be EGFR sensitising mutation (EGFRm) positive, treatment-naive and eligible for first-line treatment with an EGFR-TKI.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 years of age or older.
•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.

Exclusion Criteria

•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).
+14 more criteria

Locations (1)

Feng Ye

Xiamen, Fujian, China

Key Dates

Start Date

August 12, 2021

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2024

Last Updated

August 23, 2024

Enrollment

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer

Interventions

Icotinib

DRUG

Befotertinib

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)