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Trial Title:
Perioperative Immunotherpay Versus Adjuvant Immunotherapy for Resectable Non-small Cell Lung Cancer
NCT ID:
NCT06109402
Condition:
Stage II-IIIB(N2) Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2450
Description:
Specified dose on specified days
Arm group label:
Adjuvant immunotherapy
Arm group label:
Perioperative immunotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Specified dose on specified days
Arm group label:
Adjuvant immunotherapy
Arm group label:
Perioperative immunotherapy
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Specified dose on specified days
Arm group label:
Adjuvant immunotherapy
Arm group label:
Perioperative immunotherapy
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Specified dose on specified days
Arm group label:
Adjuvant immunotherapy
Arm group label:
Perioperative immunotherapy
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Surgery for II-IIIB (N2) non-small cell lung cancer
Arm group label:
Adjuvant immunotherapy
Arm group label:
Perioperative immunotherapy
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patient shall sign the Informed Consent Form.
2. Aged 18 ≥ years.
3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-IIIB
(N2) 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 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 immunotherapy (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
immunotherapy (whichever is later).
Exclusion Criteria:
1. 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;
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Start date:
December 20, 2023
Completion date:
November 1, 2030
Lead sponsor:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Pulmonary Hospital, Shanghai, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06109402
