Phase Ib/II Study of Almonertinib Combined With SHR-1701 in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer

Официальное название

An Open-label, Multicenter Phase Ib/II Clinical Study of Almonertinib Combined With SHR-1701 or Other Innovative Drugs in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer With EGFR Mutation

Обзор

To evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of Almonertinib combined with SHR-1701 in relapsed or advanced NSCLC To evaluate the efficacy of Almonertinib combined with SHR-1701 in the first-line treatment of relapsed or advanced NSCLC

Вмешательства

• Препарат Almonertinib combined with SHR-1701
  Phase Ⅰb/Phase Ⅱ： SHR-1701: injection, intravenous infusion Almonertinib: tablets, oral
• Препарат Almonertinib
  Phase Ⅱ: Almonertinib: tablets, oral

Первичные конечные точки

• Dose limiting toxicity （Phase Ib） [Срок оценки: 21 days after the first dose]
• The incidence and severity of ≥ grade 3 treatment-related adverse events (TRAE) and serious adverse events (TRSAE) in the combination of two drugs （Phase Ib） [Срок оценки: from the time when all informed subjects signed the informed consent to the end of the safety follow-up period]
• PFS rate at 12 months [Срок оценки: 12 months after the first medication for the last subject]

Вторичные конечные точки (8)

• Adverse Events and Serious Adverse Events [Срок оценки: up to 3 years]
• Proportion of dose pauses, dose downgrades and dose terminations due to study-drug related toxicities during the trial [Срок оценки: up to 3 years]
• ORR [Срок оценки: up to 3 years]
• DCR [Срок оценки: up to 3 years]
• DoR [Срок оценки: up to 3 years]
• DepOR [Срок оценки: up to 3 years]
• PFS [Срок оценки: up to 3 years]
• OS [Срок оценки: up to 5 years]

Критерии участия

Критерии включения

• Patients voluntarily joined the study and signed informed consent
• Age 18\~75 years old, both male and female
• Advanced NSCLC diagnosed by histology or cytology, or recurrent NSCLC after radical treatment such as surgery, radiotherapy, chemoradiotherapy
• At least one measurable lesion based on RECIST v1.1 criteria
• ECOG PS score: 0-1
• Have a life expectancy of at least 3 months
• Fertile women must have a negative serum pregnancy test within 3 days before the first dose and must be non-lactating

Критерии исключения

• Untreated Brain metastases with clinical symptoms; Or accompanied by meningeal metastasis, spinal cord compression，etc.
• Uncontrolled pleural, pericardial, or abdominal effusion with clinical symptoms
• Suffering from other malignant tumors in the past 3 years or at the same time
• Presence of any active or known autoimmune disease
• Subjects who had been systematically treated with corticosteroids (>10 mg/ day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose (randomization)
• Any severe or uncontrolled ocular lesions that, in the judgment of the investigator, may increase the subject's safety risk
• Have clinical symptoms or diseases of the heart that are not well controlled
• Patients with hypertension who are not well controlled by antihypertensive medication
• Any bleeding event of grade 2 or more or hemoptysis (volume of hemoptysis ≥2ml in a single episode) occurring within 2 weeks before the first dose (randomization); Clinically significant bleeding symptoms or definite bleeding tendency before the first medication (randomization)
• Have known history of serious infections within 1 month prior to the first dose(randomization), including but not limited to infectious complications that require hospitalization, bacteremia, and severe pneumonia; use antibiotics within 1 week prior to the first dose(randomization); have any active infections requiring intravenous systemic therapy, or have a fever > 38.5°C of unknown cause before the first dose(randomization).
• Have active or prior documented interstitial pneumonia/interstitial lung disease or pneumonitis that requires glucocorticoid treatment (e.g., radiation pneumonitis); Have active pneumonia at present
• Have active pulmonary tuberculosis.
• Have known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS). Have known active hepatitis B or C.
• Had received lung radiation therapy within 6 months before the first dose (randomization); Had received major surgical treatment (except diagnostic surgery), systemic chemotherapy, immunotherapy, or other investigational drugs within 4 weeks prior to the first medication (randomization); Received palliative radiotherapy within 2 weeks before the first dose (randomization); Oral administration of molecular targeted drugs, less than 5 half-lives before discontinuation of the drug to the first dose (randomization); Failure to recover from toxicity and/or complications of previous interventions to NCI-CTC AE grade≤1

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05503888 · SHR-1701-215

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗