Induction Therapy With Serplulimab Combined With Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer
NCT ID: NCT06591910
Last Updated: 2024-09-19
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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NOT_YET_RECRUITING
50 participants
OBSERVATIONAL
2024-09-20
2030-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Induction chemoimmunotherapy followed by surgery or radiotherapy for unresectable stage III NSCLC
Chemoimmunotherapy
Induction Serplulimab combined with chemotherapy
Surgery
After induction chemoimmunotherapy, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.
Radiation
After induction chemoimmunotherapy, patients with tumors still unresectable will receive radiotherapy or other therapy.
Interventions
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Chemoimmunotherapy
Induction Serplulimab combined with chemotherapy
Surgery
After induction chemoimmunotherapy, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.
Radiation
After induction chemoimmunotherapy, patients with tumors still unresectable will receive radiotherapy or other therapy.
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 ≥ years.
3. Histological or cytological diagnosis of unresectable NSCLC by needle biopsy, and stage III (8th TNM) confirmed by imageological examinations (CT, PET-CT or EBUS).
4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
5. Life expectancy is at least 12 weeks.
6. At least 1 measurable lesion according to RECIST 1.1.
7. Patients with good function of other main organs (liver, kidney, blood system, etc.)
8. Patients with normal lung function can tolerate surgery;
9. Without systematic metastasis (including M1a, M1b and M1c);
10. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
11. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later).
Exclusion Criteria
2. 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;
3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
4. Participants who are allergic to the test drug or any auxiliary materials;
5. Participants with Interstitial lung disease currently;
6. Participants with active hepatitis B, hepatitis C or HIV;
7. Pregnant or lactating women;
8. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
9. Participated in another therapeutic clinical study;
10. Other factors that researchers think it is not suitable for enrollment.
18 Years
ALL
No
Sponsors
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Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Peng Zhang
Professor
Central Contacts
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Other Identifiers
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LungMate-Unresectable
Identifier Type: -
Identifier Source: org_study_id
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