Neoadjuvant Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy for Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial

Обзор

For stage III non-small cell lung cancer (NSCLC), neoadjuvant chemotherapy plus PD-1 antibody is recommended. However, most patients could not achieve complete pathological response (CPR). New immunotherapeutic strategy is needed to achieve higher CPR rate. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA) which restrains the function of immune cells and leads to immune escape of tumor cells. The combination of PD-1 antibody and BTLA antibody has shown good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 plus chemotherapy in stage III NSCLC.

Вмешательства

• Препарат Toripalimab
  Specified dose on specified days.
• Препарат JS004
  Specified dose on specified days.
• Препарат Pemetrexed
  Specified dose on specified days.
• Препарат Nab-paclitaxel
  Specified dose on specified days.
• Препарат Carboplatin
  Specified dose on specified days.
• Процедура Surgery
  Patients with resectable tumor after neoadjuvant therapy will be treated with surgery.

Первичные конечные точки

• Pathologic complete response (PCR) rate [Срок оценки: Up to 30 months]

Вторичные конечные точки (9)

• Objective response rate (ORR) [Срок оценки: up to 30 months]
• Major pathologic response (MPR) rate [Срок оценки: Up to 30 months]
• Treatment-related adverse event (TRAE) [Срок оценки: Up to 30 months]
• Rate of conversion from potentially resectable to resectable [Срок оценки: Up to 30 months]
• R0 resection rate [Срок оценки: Up to 30 months]
• Event-free survival (EFS) [Срок оценки: up to 60 months]
• Overall survival (OS) [Срок оценки: up to 60 months]
• EORTC-QLQ-C30 scale [Срок оценки: up to 5 months]
• EORTC-QLQ-L13 scale [Срок оценки: up to 5 months]

Критерии участия

Критерии включения

• The patient shall sign the Informed Consent Form.
• Aged 18 ≥ years.
• Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS).
• Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
• Life expectancy is at least 12 weeks.
• At least 1 measurable lesion according to RECIST 1.1.
• Patients with good function of other main organs (liver, kidney, blood system, etc.)
• Patients with lung function can tolerate surgery;
• Without systematic metastasis (including M1a, M1b and M1c);
• Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
• Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later).

Критерии исключения

• Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
• Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
• With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
• Participants who are allergic to the test drug or any auxiliary materials;
• Participants with Interstitial lung disease currently;
• Participants with active hepatitis B, hepatitis C or HIV;
• Pregnant or lactating women;
• Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
• Participated in another therapeutic clinical study;
• Other factors that researchers think it is not suitable for enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05891080 · LungMate-014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗