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Carcinoma, Non-Small-Cell LungPhase 2NCT05263947

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

A Phase 2 study testing Bevacizumab and Icotinib in people with Carcinoma, Non-Small-Cell Lung and Bevacizumab, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Bevacizumab and Icotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
30 Jan 2022to 30 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet ALL of the following criteria to be eligible for study enrollment:
  • Voluntary provision of written informed consent prior to any study-specific procedures.
  • Age ≥ 18 and ≤75 years at the time of signing informed consent.
  • Willing and able to comply with the study protocol, as judged by the investigator.
  • 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
  • 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.
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  • Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Life expectancy of ≥ 12 weeks.
  • Prior Therapy:
  • No prior systemic cytotoxic chemotherapy for advanced or metastatic disease.
  • Prior intra-cavitary cytotoxic agent administration for pleurodesis is excluded.
  • Prior neoadjuvant or adjuvant chemotherapy is permitted if completed ≥ 6 months prior to enrollment.
  • Prior radiotherapy is allowed provided:
  • No thoracic radiotherapy within 28 days prior to enrollment.
  • For radiotherapy outside the thorax, a washout period of ≥ 28 days from the last dose to enrollment is required. (For palliative radiotherapy to bone metastases within 2 weeks prior to enrollment, patients must have recovered from all related toxicities.)
  • At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Previously irradiated lesions cannot be considered as target lesions.
  • Adequate Hematological Function:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
  • Platelet count ≥ 100 × 10⁹/L
  • Hemoglobin ≥ 9.0 g/dL (transfusion allowed to achieve this level)
  • Adequate Hepatic Function:
  • Total bilirubin ≤ 1.5 × the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases)
  • Adequate Renal Function:
  • Serum creatinine ≤ 1.5 × ULN OR calculated creatinine clearance ≥ 45 mL/min (using Cockcroft-Gault formula)
  • Urine dipstick for proteinuria < 2+. If dipstick reading is ≥ 2+, a 24-hour urine collection must demonstrate ≤ 1 g of protein per 24 hours.
  • Coagulation Parameters: International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN within 7 days prior to enrollment.
  • For women of childbearing potential: agreement to remain abstinent or use highly effective contraceptive methods (failure rate < 1% per year) during the treatment period and for at least 6 months after the last dose of study drug. For men: agreement to remain abstinent or use a condom plus an additional effective contraceptive method, and to refrain from sperm donation, during the treatment period and for at least 6 months after the last dose of study drug.

Who cannot join

  • Patients who meet ANY of the following criteria will be excluded from the study:
  • History of mixed adenosquamous histology with predominant squamous component.
  • Presence of any other concomitant EGFR mutation (e.g., exon 19 deletion, T790M) as detected by high-sensitivity testing (e.g., digital PCR).
  • History or evidence of symptomatic or untreated central nervous system (CNS) metastases. Patients with previously treated CNS metastases are eligible if they are clinically stable and radiologically stable (without evidence of progression) for ≥ 28 days after CNS-directed therapy prior to enrollment.
  • History of significant hemoptysis (> 2.5 mL of bright red blood per episode) within 3 months prior to enrollment.
  • Radiological evidence of tumor invasion or encasement of major blood vessels (e.g., pulmonary artery, superior vena cava).
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  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of the need for major surgery during the study.
  • Core biopsy or other minor surgical procedure (excluding placement of a vascular access device) within 7 days prior to the first dose of study treatment. Placement of a vascular access device must be completed at least 2 days prior to treatment initiation.
  • Current or recent (within 10 days prior to initiation of bevacizumab) use of full-dose aspirin (> 325 mg/day) or other NSAIDs known to inhibit platelet function.
  • Current or recent (within 10 days prior to initiation of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes. Prophylactic use of low-dose anticoagulants is permitted.
  • Known hereditary or acquired bleeding diathesis or coagulopathy with a high risk of bleeding.
  • Poorly controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg).
  • History of hypertensive crisis or hypertensive encephalopathy.
  • Significant cardiovascular disease within 6 months prior to enrollment, including but not limited to: cerebrovascular accident/transient ischemic attack, myocardial infarction, unstable angina, New York Heart Association (NYHA) Class II or greater congestive heart failure, or severe cardiac arrhythmia requiring medication that may interfere with the regularity of study treatment.
  • Severe peripheral vascular disease (e.g., aortic aneurysm requiring surgical intervention, recent arterial thrombosis) within 6 months prior to enrollment.
  • Non-healing wound, active peptic ulcer, or untreated bone fracture.
  • History of gastrointestinal perforation, abdominal fistula, or intra-abdominal abscess within 6 months prior to enrollment.
  • Pregnancy, lactation, or intention to become pregnant during the study period.
  • Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to enrollment.
  • Known hypersensitivity to any component of the bevacizumab formulation, Chinese hamster ovary cell products, icotinib, or its excipients.
  • Active infection requiring systemic intravenous antibiotic therapy at the time of enrollment.
  • Presence of a tracheo-esophageal fistula.
  • Any prior systemic anti-cancer therapy (including chemotherapy, monoclonal antibodies, tyrosine kinase inhibitors, EGFR inhibitors, VEGF inhibitors) for advanced (Stage IIIB/IV) or recurrent NSCLC. (Note: Adjuvant/neoadjuvant therapy completed ≥ 6 months prior to enrollment is allowed.)
  • Inability to swallow oral medications, malabsorption syndrome, or any condition significantly affecting gastrointestinal function that would impair the absorption of icotinib.
  • Presence of severe dry eye syndrome, severe keratitis, keratoconjunctivitis, or any other ocular surface condition that may increase the risk of epithelial damage. Use of contact lenses during the study is not recommended.
  • History of other active malignancies within 5 years prior to enrollment, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, localized prostate cancer, or ductal carcinoma in situ of the breast treated with curative intent.
  • Any condition that may interfere with study results, compromise subject safety, or preclude full participation as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: 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

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.

Being tested
Bevacizumab, Icotinib
Keywords
bevacizumab, icotinib, EGFR L858R, advanced non-small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    15 mg/kg, intravenous infusion, every three weeks

  • IcotinibDrug

    Oral 250 mg, three times per day

Study groups in NCT05263947
Study groupRoleWhat they receive
Bevacizumab Combined with IcotinibExperimentalParticipants receive bevacizumab 15 mg/kg by intravenous infusion once every 3 weeks, and oral icotinib 250 mg three times per day until disease progression or unacceptable toxicity.
Receives: Drug: Bevacizumab; Drug: Icotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    PFS was defined as the time from the initial treatment to the first occurrence of disease progression or all-cause death (whichever occurs first ) assessed by the investigator according to RECIST v1.1.

    Measured: 18 months

Secondary outcomes (3)

  1. Overall survival(OS)

    OS was defined as the time from the initial treatment until the date of death due to any cause.

    Measured: 44 months

  2. Objective response rate(ORR)

    ORR was defined as the percentage of patients with a confirmed complete (CR) or partial response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator.

    Measured: up to 6 months

  3. Disease Control Rate (DCR)

    DCR was defined as the proportion of patients with the best overall response of CR, PR, and stable disease (SD) as determined by the investigator according to RECIST 1.1.

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start30 Jan 2022
  3. Primary completion30 Dec 2023
  4. Study completion30 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05263947
Sponsor's protocol ID
Beddi21
Status last verified
Jan 2023
First submitted
18 Jan 2022
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab and Icotinib in people with Carcinoma, Non-Small-Cell Lung and Bevacizumab, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05263947.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.

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