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Bevacizumab Combined With Double Doses of Icotinib in Advanced NSCLC Patients With EGFR L858R Mutation | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Bevacizumab Combined With Double Doses of Icotinib in Advanced NSCLC Patients With EGFR L858R Mutation

Efficacy and Safety of Bevacizumab Combined With Double Doses of Icotinib in Advanced Non-squamous Non-small Cell Lung Cancer With EGFR Exon 21 L858R Mutation: a Prospective, Single-arm, Phase 2 Clinical Trial

NCT05263947•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, single-center, phase II trial designed to evaluate the efficacy and safety of bevacizumab combined with a double dose of icotinib as a first-line treatment for patients with advanced non-squamous non-small cell lung cancer (NSCLC) harboring an EGFR Exon 21 L858R mutation. Patients will receive bevacizumab and icotinib (250 mg, administered orally three times per day ) until disease progression or unacceptable toxicity. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and toxicity profile. The hypothesis is that the combination therapy will provide improved outcomes for this patient population, which typically has a poorer response to standard EGFR-TKI therapy.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet ALL of the following criteria to be eligible for study enrollment:
•1. Voluntary provision of written informed consent prior to any study-specific procedures.
•2. Age ≥ 18 and ≤75 years at the time of signing informed consent.
•3. Willing and able to comply with the study protocol, as judged by the investigator.
•4. Histologically or cytologically confirmed, unresectable, locally advanced (Stage IIIB, not amenable to radical chemoradiotherapy), metastatic (Stage IV), or recurrent non-squamous non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer staging manual, eighth edition
•5. Documented EGFR exon 21 L858R mutation, as centrally confirmed by a high-sensitivity PCR-based test on tumor tissue. Results from direct sequencing are also acceptable.
•6. Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
•7. Life expectancy of ≥ 12 weeks.
•8. Prior Therapy:
•* No prior systemic cytotoxic chemotherapy for advanced or metastatic disease.
+41 more criteria

Exclusion Criteria

•Patients who meet ANY of the following criteria will be excluded from the study:
•1. History of mixed adenosquamous histology with predominant squamous component.
•2. Presence of any other concomitant EGFR mutation (e.g., exon 19 deletion, T790M) as detected by high-sensitivity testing (e.g., digital PCR).

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

January 30, 2022

Primary Completion Date

December 30, 2023

Completion Date

December 30, 2023

Last Updated

February 24, 2026

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell LungBevacizumabTyrosine Kinase InhibitorEGFR L858R

Interventions

Bevacizumab

DRUG

Icotinib

DRUG

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

NCT04165798

Carcinoma, Non-Small-Cell Lung

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RECRUITINGPHASE2

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

NCT06667908

Carcinoma, Non-Small-Cell Lung

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RECRUITING

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: February 24, 2026Data 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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Bevacizumab Combined With Double Doses of Icotinib in Advanced NSCLC Patients With EGFR L858R Mutation

Inclusion Criteria

Exclusion Criteria

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

A Study of LY4175408 in Participants With Advanced Cancer

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)