Not yet recruiting NCT06109402
Perioperative Immunotherpay Versus Adjuvant Immunotherapy for Resectable Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TQB2450, Carboplatin, Pemetrexed, Nab-paclitaxel.
- Who it may be relevant to
- Registry conditions: Stage II-IIIB(N2) Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
For resectable non-small cell lung cancer, neoadjuvant immunochemotherapy plus adjuvant immunotherapy or adjuvant immunochemotherapy is usually used in clinical practice. However, it is unclear whether therapeutic strategy is superior. This trial aims to compare the efficacy and safety of these two strategies.
Interventions
- Drug TQB2450
Specified dose on specified days - Drug Carboplatin
Specified dose on specified days - Drug Pemetrexed
Specified dose on specified days - Drug Nab-paclitaxel
Specified dose on specified days - Procedure Surgery
Surgery for II-IIIB (N2) non-small cell lung cancer
Primary outcome measures
- 3-year event-free survival (EFS) rate [Time frame: Up to 48 months]
Secondary outcome measures (9)
- Objective response rate (ORR) [Time frame: Up to 6 months]
- Pathological complete response (pCR) [Time frame: Up to 8 months]
- Major pathologic response (MPR) [Time frame: Up to 8 months]
- Event-free survival (EFS) [Time frame: Up to 72 months]
- Overall survival (OS) [Time frame: Up to 72 months]
- 5-year event-free survival (EFS) rate [Time frame: Up to 72 months]
- 5-year overall survival (OS) [Time frame: Up to 72 months]
- Adverse event rate [Time frame: Up to 36 months]
- Health related quality of life (HRQol) [Time frame: Up to 36 months]
Eligibility criteria
Inclusion criteria
- The patient shall sign the Informed Consent Form.
- Aged 18 ≥ years.
- Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-IIIB (N2) 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 immunotherapy (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 immunotherapy (whichever is later).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Pulmonary Hospital — Shanghai
Identifiers
NCT: NCT06109402 · LungMate-019