Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer
NCT ID: NCT05116462
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
506 participants
INTERVENTIONAL
2024-03-15
2028-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sintilimab
Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of sintilimab plus platinum-based chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
Pemetrexed
500 mg/m2 D1 IV Q3W
Carboplatin
AUC 5 or 6 mg/ml/min D1 IV Q3W
Paclitaxel
175 or 200 mg/m2 D1 IV Q3W
Sintilimab
200 mg D1 IV Q3W
Cisplatin
75 mg/m2 D1 IV Q3W
Nab paclitaxel
100 mg/m2 D1, 8, 15 IV Q3W
Placebo
Neoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery.
adjuvant Treatment period: Subjects will receive 1 cycle of placebo plus platinum-based chemotherapy, and then receive placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
Pemetrexed
500 mg/m2 D1 IV Q3W
Carboplatin
AUC 5 or 6 mg/ml/min D1 IV Q3W
Paclitaxel
175 or 200 mg/m2 D1 IV Q3W
Cisplatin
75 mg/m2 D1 IV Q3W
Nab paclitaxel
100 mg/m2 D1, 8, 15 IV Q3W
Placebo
20 ml D1 IV Q3W
Interventions
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Pemetrexed
500 mg/m2 D1 IV Q3W
Carboplatin
AUC 5 or 6 mg/ml/min D1 IV Q3W
Paclitaxel
175 or 200 mg/m2 D1 IV Q3W
Sintilimab
200 mg D1 IV Q3W
Cisplatin
75 mg/m2 D1 IV Q3W
Nab paclitaxel
100 mg/m2 D1, 8, 15 IV Q3W
Placebo
20 ml D1 IV Q3W
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma).
4. Subjects with Stage II, IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8).
5. Deemed radically resectable with curative intent.
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
7. Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC.
Exclusion Criteria
2. Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization.
3. Received Chinese herbal medicine, Chinese traditional medicine with anti-tumor indications, or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within two weeks prior to randomization
4. Received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study).
5. Requiring long term systemic corticosteroids
6. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known active syphilis.
7. Active hepatitis B.
18 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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CIBI308G301
Identifier Type: -
Identifier Source: org_study_id
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