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Non-Small Cell Lung CancerPhase 2NCT05007938

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

A Phase 2 study testing Icotinib and Befotertinib in people with Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Icotinib and Befotertinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
12 Aug 2021to 31 Dec 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 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.
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  • 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.

Who cannot join

  • 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.
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  • 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
  • platelets<100,000/mcL
  • hemoglobin<9.0 g/dL
  • AST/ALT>2.5 times the upper limit of normal (ULN)or >5 times the ULN in the presence of liver metastases
  • total bilirubin(TBIL)>1.5 times the ULN if no liver metastases or > 3 times the ULN in the presence of liver metastases
  • serum creatinine(SCr) >1.5 times the ULN or creatinine clearance ≥50 mL/min.
  • Patients with a known allergy or delayed hypersensitivity reaction to the any component of study drugs or their excipients.
  • Within 1 week before the first dose of study drug currently receiving or need concomitant medications known to be potent inhibitors or inducers of CYP3A, CYP2D6,CYPC8 and CYP2C19,sensitive substrate of CYP3A and CYP2C9.
  • Within 1 week before the first dose of study drug ongoing use of warfarin.
  • Previous therapeutic clinical trial within 4 weeks before the first dose of study drug.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Feng Ye

    Xiamen, Fujian, 361003

Other trials in China

About this study

Official title: 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

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.

Read the 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.

Being tested
Icotinib, Befotertinib
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.

  • IcotinibDrug

    Also called Conmana

    Icotinib is a EGFR ihibitior.

  • BefotertinibDrug

    Also called D-0316

    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.

Study groups in NCT05007938
Study groupRoleWhat they receive
Icotinib + BefotertinibExperimental* Icotinib（125 mg orally, three times daily） * Befotertinib（25 mg orally, three times daily）
Receives: Drug: Icotinib; Drug: Befotertinib

What is being measured

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

  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).

    Measured: 24 months

Secondary outcomes (6)

  1. Duration of response（DOR）

    DOR, defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death in the absence of disease progression.

    Measured: 24 months

  2. Disease control rate（DCR）

    DCR, defined as proportion of complete response, partial response, and disease stabilization to the proportion of patients with evalueable tumors.

    Measured: 24 months

  3. Progression-free survival（PFS）

    PFS, defined as time from study drug administration to progression or death due to any cause.

    Measured: 36 months

  4. Intracranial objective response rate（iORR）

    iORR, defined as the proportion of subjects with complete intracranial response, partial intracranial response to subjects with brain metastasis target lesions at baseline.

    Measured: 24 months

  5. Overall survival （OS）

    OS, defined as the time from study drug administration until the date of death due to any cause.

    Measured: 36 months

  6. Adverse event（AE）

    AE,defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered related to the study drugs. AEs are summarized by type, incidence, severity and relationship to study drugs.

    Measured: 36 months

Timeline

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

  1. First posted17 Aug 2021
  2. Study start12 Aug 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05007938
Sponsor's protocol ID
BD-BF-IV01
Status last verified
Aug 2024
First submitted
8 Aug 2021
Last updated
23 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Icotinib and Befotertinib in people with Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. 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 9 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. 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?

Results are not available in the source record.

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?

Objective Response Rate （ORR） (time frame: 24 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 NCT05007938.

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 23 Aug 2024.

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