Status:
NOT_YET_RECRUITING
Induction Therapy With Serplulimab Combined With Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Conditions:
Unresectable Stage III Non-small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
For unresectable stage III (8th TNM) non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether induction chemoimmunotherapy follo...
Eligibility Criteria
Inclusion
- The patient shall sign the Informed Consent Form.
- Aged 18 ≥ years.
- Histological or cytological diagnosis of unresectable NSCLC by needle biopsy, and stage III (8th TNM) 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 normal 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 Serplulimab (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 Serplulimab (whichever is later).
Exclusion
- 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.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 20 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06591910
Start Date
September 20 2024
End Date
September 20 2030
Last Update
September 19 2024
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