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RECRUITINGPHASE2

Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations

A Phase II Study to Assess Befotertinib and Icotinib as First-Line Treatment in Patients With Locally Advanced or Metastatic NSCLC and Uncommon EGFR Mutation(IcomBine, GASTO-10114)

NCT06517953•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 years of age or older.
•3. 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.
•4. 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;
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
•6. Predicted survival ≥ 3 months.
•7. At least 1 measurable tumor lesion without radiotherapy as per RECIST v1.1.
•8. Agree to use effective contraception during the study period and for at least 3 months after completion of the study treatment.
•9. Provision of informed consent prior to any study procedure.

Exclusion Criteria

•1. Combined with other malignancy(except for clinically cured in situ cervix carcinoma, basal cell or squamous epithelial skin cancer,thyroid papillary carcinoma).
•2. Prior treatment with any EGFR-TKIs.
•3. Prior treatment with any systemic antitumor therapy for locally advanced or metastatic NSCLC.
•4. Previous traditional chinese medicine with an antitumor indication within 2 weeks before the first dose of study drug.
•5. Previous major surgery within 4 weeks before the first dose of study drug,or planing to have major surgery during study.
•6. Symptoms or signs worsened within 2 weeks before the first dose of study drug.
•7. Any unresolved toxicities from prior treatment greater than NCI CTCAE v4.03 grade 2 or higher.
•8. 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.
•9. 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.
•10. Active infection including hepatitis B,hepatitis C,syphilis and human immunodeficiency virus (HIV).
+14 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

July 17, 2024

Primary Completion Date

July 30, 2026

Completion Date

December 24, 2027

Last Updated

July 25, 2024

Enrollment

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer MetastaticEGFR G719XEGFR L861QEGFR S768I

Interventions

Icotinib

DRUG

Befotertinib

DRUG

Contacts

Xue Hou, MD

CONTACT

135 7056 9436 houxue@sysucc.org.cn

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

NCT07250477

Non-small Cell Lung Cancer Stage IIICNon-small Cell Lung Cancer Stage IV+3 more

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ACTIVE_NOT_RECRUITINGPHASE2

An Exploratory Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma and Non-Small Cell Lung Cancer With Liver Metastases (INTEGRATE)

NCT04563338

Hepatocellular CarcinomaNon-small Cell Lung Cancer Metastatic+1 more

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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: July 25, 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 for NSCLC With Uncommon EGFR Mutations

Inclusion Criteria

Exclusion Criteria

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

An Exploratory Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma and Non-Small Cell Lung Cancer With Liver Metastases (INTEGRATE)

Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed & Carboplatin (PC) for Metastatic Non-Squamous NSCLC

Dacomitinib in Lung Cancer With Uncommon EGFR Mutations

Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr

Xingbai Ji Formula Combined with Chemotherapy and Sintilimab in Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer: a Clinical Trial