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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Befotertinib + Icotinib placebo | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) evaluated by investigator in patients with stage II-IIIB (T3N2M0) | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| DFS evaluated by investigator in patients with stage IB-IIIB (T3N2M0) | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| DFS rate at 2 years | Assessed at 2 years | |
| DFS rate at 3 years | Assessed at 3 years | |
| DFS rate at 5 years |
Inclusion Criteria:
Exclusion Criteria:
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).
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:
Within 6 months before the first medication, there were the following situations:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shun Lu, M.D. | Contact | +86 21 2220 0000 | shunlu@sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shun Lu, M.D. | Shanghai Chest Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University International Hospital | Recruiting | Beijing | China | |||
| Jiangsu Cancer Hospital |
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|
| Icotinib + Befotertinib placebo | Drug | 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. |
|
| Assessed at 5 years |
| Overall survival (OS) | Assessed at 5 years |
| OS rate at 5 years | up to 5 years |
| Treatment-Emergent Adverse Event (TEAE) | Until 28 days after the last dosing |
| Recruiting |
| Nanjing |
| China |
| Shanghai chest hospital | Recruiting | Shanghai | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C531470 | icotinib |
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