Non-small Cell Lung Cancer Clinical Trial
Official title:
Neoadjuvant Immunotherapy With Chemotherapy for the Treatment of Stage I-IIIB Non-Small Cell Lung Cancer (NSCLC): A Phase II Exploratory Study
A phase II, single-arm, open-label study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with PD-(L)1 inhibitor in stage I-IIIB NSCLC adult patients followed by adjuvant PD-(L)1 inhibitor treatment for up to 1 year
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 1.Histologically- or cytologically- documented NSCLC who present stage I (T=4cm), IIA, IIB, IIIA, or IIIB disease, of either squamous or non-squamous histology. 2.Deemed surgically resectable by a thoracic surgeon 3.Age = 18 years 4.Radiologically measurable disease, as defined by response evaluation criteria in solid tumours (RECIST) v1.1 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 6.Notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines. Exclusion Criteria: - 1. Carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene or other mutations predicting hyperprogression of immunotherapy. 2. Active, known or suspected autoimmune disease. 3.Other active malignancy requiring concurrent intervention or with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast). 4.Prior treatment with anti-PD-1, anti-CTLA-4 (cytotoxic T lymphocyte-associated antigen (CTLA-4), or anti-PD-L1 therapeutic antibody or pathway-targeting agents 5.History of allergy to study drug components excipients |
Country | Name | City | State |
---|---|---|---|
China | China | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MPR (major pathologic response) | Major pathologic response (MPR) is defined as > 90 percent decrease in viable tumor. | Up to 8 weeks | |
Secondary | DFS(disease-free survival) | Time from first dose of neoadjuvant treatment to recurrence of tumor or death | at 3 years from the first dose of neoadjuvant treatment | |
Secondary | OS(overall survival) | Time when the patient is still alive | at 3 years from the first dose of neoadjuvant treatment | |
Secondary | Toxicity profile | Toxicities caused by the drug during the study,according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment |
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