A Phase 2 interventional study of PD-1 inhibitor in Non-small Cell Lung Cancer, sponsored by Peking Union Medical College. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-28.
Sponsored by Peking Union Medical College · Phase 2, Interventional, and Treatment
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
A phase II, single-arm, open-label study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with PD-1 inhibitor in stage I-IIIB NSCLC adult patients followed by adjuvant treatment for up to 1 year with PD-(L)1 inhibitor.
Two to three cycles of neoadjuvant chemotherapy in combination with PD-(L)1 inhibitor will be administered before surgery, followed by another one to two cycles of neoadjuvant chemotherapy in combination with PD-(L)1 inhibitor and PD-(L)1 inhibitor monotherapy for up to 1 year.
After completion of neoadjuvant therapy and before surgery, a tumor assessment will be done. Patients with stable disease or partial response may be considered for surgery.
The report imaging response and pathological response rate will be evaluated. Patients eligible for the trial are those with a histological diagnosis or cytologically proven operable and resectable non-small-cell lung cancer. The total number of patients to be included will be 60 from Chinese Academy of Medical Sciences (CAMS).
Accrual period of 2 years or until the inclusion of the last patient necessary to achieve the sample set in the protocol of 60 patients. After that all patients will be treated for up to 1 year with adjuvant immunotherapy and they will be followed during 3 years after adjuvant treatment.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Peking Union Medical College is the lead sponsor of 58 studies on the registry; 17 are open to participants now.
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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:
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.
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
Drug: PD-1 inhibitor
Two to three cycles of neoadjuvant chemotherapy in combination with PD-(L)1 inhibitor will be administered before surgery, followed by another one to two cycles of neoadjuvant chemotherapy in combination with PD-(L)1 inhibitor and PD-(L)1 inhibitor monotherapy for up to 1 year.
MPR (major pathologic response)
Major pathologic response (MPR) is defined as \> 90 percent decrease in viable tumor.
Time frame: Up to 8 weeks
DFS(disease-free survival)
Time from first dose of neoadjuvant treatment to recurrence of tumor or death
Time frame: at 3 years from the first dose of neoadjuvant treatment
OS(overall survival)
Time when the patient is still alive
Time frame: at 3 years from the first dose of neoadjuvant treatment
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
Time frame: from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment
Plan to share: No
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This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College