Non-Small Cell Lung CancerPhase 3NCT06041776
Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations
A Phase 3 study of Non-Small Cell Lung Cancer and EGFR Sensitive Mutation, run by Betta Pharmaceuticals Co., Ltd. at 3 sites in China.
Trial summary
This multicenter, randomized, controlled, double-blind, double-simulated, Phase III study is designed to evaluate the efficacy and safety of Befotertinib compared with Icotinib as adjuvant treatment in EGFR-sensitive mutation-positive stage IB-IIIB (T3N2M0) non-small cell lung cancer after surgical resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, EGFR Sensitive Mutation, Adjuvant Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 570 participants
- Where
- 3 sitesChina
- Study dates
- 28 Mar 2023to 30 Nov 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Willingness to sign informed consent prior to any study specific procedures, and ability to with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Male or female, aged at least 18 years.
- Histologically confirmed primary NSCLC, and mainly non-squamous cell carcinoma (including mixed type carcinoma mainly composed of adenocarcinoma components).
- Absence of brain metastasis.
- Complete resection of histologically confirmed Stage IB, II, IIIA or IIIB(T3N2M0) according to the TNM staging system for lung cancer (AJCC/UICC 8th edition), with negative margins.
- Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).
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- Patients who fully recover from surgery during randomization (any surgery must achieve complete postoperative wound healing) and should receive adjuvant treatment within 4-10 weeks after surgery.
- ECOG-PS score of 0 or 1 and did not deteriorate 2 weeks before the first administration of the investigational drug, with a minimum expected survival greater than 12 weeks.
- Female subjects with fertility need to have a negative serum pregnancy test during screening.
- Female subjects who have possibility of becoming pregnant, as well as male subjects whose partners are women of childbearing age, must use a highly effective contraceptive method (such as oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) throughout the study and continue to use contraception for 3 months after the end of treatment.
Who cannot join
- There are unresectable or metastatic diseases, pathological reports showing positive surgical margins under the microscope or extranodal invasion, or lesions left after surgery, or suspicious lesions determined by imaging after surgery. Subjects receiving only wedge resection.
- Upper lung groove cancer.
- Patient with complete resection of the right lung with NSCLC.
- Malignancies other than NSCLC within 5 years prior to first dosage, except for malignant tumors that can be cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery).
- Received systematic anti-tumor therapy, including chemotherapy, radiotherapy or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors), immunotherapy, investigational therapy, etc., before being enrolled in this study.
- Within 3 weeks prior to the first administration of the investigational drug, the patient underwent major surgery (including primary tumor surgery, craniotomy, thoracotomy, or laparotomy, excluding vascular pathway establishment procedures).
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- Within 14 days prior to first dose of the investigational drug, Traditional Chinese medicine with anti-tumor indications have been received.
- After the start of the study, any form of systemic or local anti-tumor treatment (including maintenance therapy with another drug, radiotherapy, and/or surgical resection) is still required.
- Clinically significant cardiovascular diseases, including:
- QTcF interval >450 ms (men) or >470 ms (women), symptomatic bradycardia (<45 beats /min), or other significant ECG abnormalities as determined by the investigator (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250 msec).
- Echocardiography showed LVEF <50%.
- Hypertension was clinically uncontrollable (e.g., blood pressure >160/100 mmHg; Except that isolated elevated readings that were determined by the investigators to be clinically insignificant or controllable hypertension.)
- Within 6 months before the first medication, there were the following situations:
- Congestive heart failure (New York Heart Association rating III or IV).
- Arrhythmias or conduction abnormalities that require medication treatment. Note: Patients with drug-controlled atrial fibrillation/flutter, as well as those with pacemaker- controlled arrhythmia, can be selected.
- Severe/unstable angina, coronary artery/peripheral bypass grafting, or myocardial infarction (Note: Severe angina is classified as Grade III or IV by the Canadian Society of Cardiology).
- Cerebrovascular accidents or transient ischemic attacks, transient myocardial ischemia.
- Previous history of concomitant interstitial lung disease (ILD), drug-induced ILD, radiation pneumonia requiring hormone therapy, or clinical evidence of concomitant active interstitial lung disease.
- Patients who have a history of thrombosis or are currently present with thrombosis or have a potential risk of thrombosis assessed by the investigator.
- Any clinical evidence of a serious active infection, or any serious concomitant disease that may affect the subject's acceptance of investigational drugs, such as active bleeding predisposition, active hepatitis B, hepatitis C, or tuberculosis, syphilis, or HIV antibody positive.
- There are serious gastrointestinal functional abnormalities in clinical practice that may affect drug intake, transportation, or absorption, such as inability to take medication orally, uncontrollable nausea or vomiting, history of extensive gastrointestinal resection, untreated recurrent diarrhea, atrophic gastritis, untreated stomach diseases requiring long-term use of proton pump inhibitors, gastrointestinal obstruction, active diverticulitis, Crohn's disease, ulcerative colitis, etc.
- Abnormal laboratory parameters.
- Known hypersensitivity to the befotertinib, icotinib or their inactive excipients.
- Within one week before the first administration of the investigational drug, it is currently in use or needs to be combined with CYP3A strong inhibitors or inducers during the study period.
- Patients who are still using warfarin within 7 days prior to initial dosing (low molecular weight heparin sodium is allowed).
- Participating in clinical research and receiving treatment with the study drug or research device, or participating in clinical research and receiving treatment with the study drug or research device within 4 weeks before the first administration, or planning to participate in any other clinical trial during this study period.
- Inoculate with a live vaccine within 180 days before the first medication.
- Researchers believe that it may affect protocol compliance or affect the signing of informed consent forms by participants (such as a history of mental illness or drug abuse, alcoholism or other addiction), or any other clinically significant disease or condition that is not suitable for participation in this clinical trial (such as laboratory abnormal results, clinically active diverticulitis, abdominal abscess).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking University International Hospital
Beijing
- Recruiting
Jiangsu Cancer Hospital
Nanjing
- Recruiting
Shanghai chest hospital
Shanghai
About this study
Official title: A Multicenter, Randomized, Controlled, Double Blind, Double Simulated, Phase III Clinical Study of Befotertinib vs Icotinib for Postoperative Adjuvant Treatment of IB-IIIB (T3N2M0) Stage Non Small Cell Lung Cancer With Positive EGFR Sensitive Mutations
This multicenter, randomized, controlled, double-blind, double-simulated, Phase III study is designed to evaluate the efficacy and safety of Befotertinib compared with Icotinib as adjuvant treatment in EGFR-sensitive mutation-positive stage IB-IIIB (T3N2M0) non-small cell lung cancer after surgical resection.
- Being tested
- Befotertinib + Icotinib placebo, Icotinib + Befotertinib placebo
- 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.
Befotertinib + Icotinib placeboDrug
The initial dose of Befotertinib is 75 mg orally once daily (QD) for 21 days, and then increased to 100 mg orally QD in the absence of serious side effects , CTCAE grade ≥ 2 headache or thrombocytopenia during the 21 days.
Befotertinib can be taken on an empty stomach or after meals, and the medication is used until the disease relapses or intolerable toxicity occurs, or the treatment lasts for 3 years (disease recurrence includes local recurrence and/or distant metastasis)
Icotinib placebo 125 mg three times daily, on an empty stomach or in combination with food, use medication until the disease relapses or intolerable toxicity occurs or treatment lasts for 2 years (disease recurrence includes local recurrence and/or distant metastasis).
Icotinib + Befotertinib placeboDrug
Icotinib 125 mg three times daily, on an empty stomach or in combination with food, use medication until the disease relapses or intolerable toxicity occurs or treatment lasts for 2 years (disease recurrence includes local recurrence and/or distant metastasis).
The initial dose of Befotertinib placebo is 75 mg orally once daily (QD) for 21 days, and then increased to 100 mg orally QD in the absence of serious side effects , CTCAE grade ≥ 2 headache or thrombocytopenia during the 21 days.
Befotertinib placebo can be taken on an empty stomach or after meals, and the medication is used until the disease relapses or intolerable toxicity occurs, or the treatment lasts for 3 years (disease recurrence includes local recurrence and/or distant metastasis.
| Study group | Role | What they receive |
|---|---|---|
| Befotertinib + Icotinib placebo | Experimental | Befotertinib (75 mg or 100 mg orally, once daily) and Icotinib placebo(125 mg orally, three times daily)，in accordance with the randomization schedule Receives: Drug: Befotertinib + Icotinib placebo |
| Icotinib + Befotertinib placebo | Active comparator | Icotinib (125 mg orally, three times daily) and Befotertinib placebo (75 mg or 100 mg orally, once daily)，in accordance with the randomization schedule Receives: Drug: Icotinib + Befotertinib placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS) evaluated by investigator in patients with stage II-IIIB (T3N2M0)
Measured: up to 5 years
Secondary outcomes (1)
DFS evaluated by investigator in patients with stage IB-IIIB (T3N2M0)
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start28 Mar 2023
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, M.D., Study chair, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041776
- Sponsor's protocol ID
- BD-BF-III01
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Double Blind, Double Simulated, Phase III Clinical Study of Befotertinib vs Icotinib for Postoperative Adjuvant Treatment of IB-IIIB (T3N2M0) Stage Non Small Cell Lung Cancer With Positive EGFR Sensitive Mutations
- ClinicalTrials.gov ID
- NCT06041776
- Acronym / sponsor ID
- BD-BF-III01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, controlled, double-blind, double-simulated, Phase III study is designed to evaluate the efficacy and safety of Befotertinib compared with Icotinib as adjuvant treatment in EGFR-sensitive mutation-positive stage IB-IIIB (T3N2M0) non-small cell lung cancer after surgical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Befotertinib + Icotinib placebo | Experimental | Drug: Befotertinib + Icotinib placeboBefotertinib (75 mg or 100 mg orally, once daily) and Icotinib placebo(125 mg orally, three times daily)，in accordance with the randomization schedule |
| Icotinib + Befotertinib placebo | Active comparator | Drug: Icotinib + Befotertinib placeboIcotinib (125 mg orally, three times daily) and Befotertinib placebo (75 mg or 100 mg orally, once daily)，in accordance with the randomization schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willingness to sign informed consent prior to any study specific procedures, and ability to with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Male or female, aged at least 18 years.
- Histologically confirmed primary NSCLC, and mainly non-squamous cell carcinoma (including mixed type carcinoma mainly composed of adenocarcinoma components).
- Absence of brain metastasis.
- Complete resection of histologically confirmed Stage IB, II, IIIA or IIIB(T3N2M0) according to the TNM staging system for lung cancer (AJCC/UICC 8th edition), with negative margins.
Key exclusion criteria (28 listed)
- There are unresectable or metastatic diseases, pathological reports showing positive surgical margins under the microscope or extranodal invasion, or lesions left after surgery, or suspicious lesions determined by imaging after surgery. Subjects receiving only wedge resection.
- Upper lung groove cancer.
- Patient with complete resection of the right lung with NSCLC.
- Malignancies other than NSCLC within 5 years prior to first dosage, except for malignant tumors that can be cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery).
- Received systematic anti-tumor therapy, including chemotherapy, radiotherapy or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors), immunotherapy, investigational therapy, etc., before being enrolled in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Befotertinib + Icotinib placeboThe initial dose of Befotertinib is 75 mg orally once daily (QD) for 21 days, and then increased to 100 mg orally QD in the absence of serious side effects , CTCAE grade ≥ 2 headache or thrombocytopenia during the 21 days. Befotertinib can be taken on an empty stomach or after meals, and the medication is used until the disease relapses or intolerable toxicity occurs, or the treatment lasts for 3 years (disease recurrence includes local recurrence and/or distant metastasis) Icotinib placebo 125 mg three times daily, on an empty stomach or in combination with food, use medication until the disease relapses or intolerable toxicity occurs or treatment lasts for 2 years (disease recurrence includes local recurrence and/or distant metastasis). | Drug | Befotertinib + Icotinib placebo |
| Icotinib + Befotertinib placeboIcotinib 125 mg three times daily, on an empty stomach or in combination with food, use medication until the disease relapses or intolerable toxicity occurs or treatment lasts for 2 years (disease recurrence includes local recurrence and/or distant metastasis). The initial dose of Befotertinib placebo is 75 mg orally once daily (QD) for 21 days, and then increased to 100 mg orally QD in the absence of serious side effects , CTCAE grade ≥ 2 headache or thrombocytopenia during the 21 days. Befotertinib placebo can be taken on an empty stomach or after meals, and the medication is used until the disease relapses or intolerable toxicity occurs, or the treatment lasts for 3 years (disease recurrence includes local recurrence and/or distant metastasis. | Drug | Icotinib + Befotertinib placebo |
Primary outcome
Disease free survival (DFS) evaluated by investigator in patients with stage II-IIIB (T3N2M0)
Time frame: up to 5 years
1 secondary outcome
DFS evaluated by investigator in patients with stage IB-IIIB (T3N2M0)
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shun Lu, M.D. study chair
Shanghai Chest Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Non-Small Cell Lung Cancer and EGFR Sensitive Mutation, run by Betta Pharmaceuticals Co., Ltd. at 3 sites 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 10 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shun Lu, M.D. (+86 21 2220 0000, shunlu@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) evaluated by investigator in patients with stage II-IIIB (T3N2M0) (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2023.