A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

Официальное название

A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)

Обзор

The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.

Вмешательства

• Препарат Sugemalimab and Chemotherapy
  Chemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles. Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.

Первичные конечные точки

• ORR [Срок оценки: From the initiation of the first dose to 3 years]

Вторичные конечные точки (7)

• PFS [Срок оценки: From the initiation of the first dose to 3 years]
• OS [Срок оценки: From the initiation of the first dose to 3 years]
• iORR [Срок оценки: From the initiation of the first dose to 3 years]
• AEs [Срок оценки: From the initiation of the first dose to 90 days after the last dose]
• Measurement of Quality of Life with EORTC QLQ-C30 questionnaire [Срок оценки: From the initiation of the first dose to 3 years]
• Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire [Срок оценки: From the initiation of the first dose to 3 years]
• Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire [Срок оценки: From the initiation of the first dose to 3 years]

Критерии участия

Критерии включения

1.18 to 75 years old, both male and female;

2.ECOG score: 0-1;

3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;

4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;

5.Measurable lesions available;

6.Major organ function is basically normal;

7.Estimated survival time is at least 6 months;

8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.

Критерии исключения

• Histologically or cytologically confirmed mixed SCLC and NSCLC;
• Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);
• Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;
• Previous thoracic radiotherapy;
• Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;
• Systemic immunostimulant therapy before the first dose;
• Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
• Subjects with autoimmune diseases;
• Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
• Known or suspected interstitial pneumonia;
• Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
• Severe cardiovascular and cerebrovascular diseases;
• Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
• Arteriovenous thrombotic events within 3 months before the first dose;
• Positive HIV test;
• Active hepatitis B or C;
• Evidence of active tuberculosis infection within 1 year before the first dose;
• Serious infection within 4 weeks before the first dose;
• History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;
• Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose;
• Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
• History of severe allergic reactions to other monoclonal antibodies/fusion proteins;
• Allergic to any component of the randomized treatment regimen;
• Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;
• Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse;
• Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Hunan Cancer Hospital — Чанша

Идентификаторы

NCT: NCT05940532 · HTOSG Lung 001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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