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Neoadjuvant Immunotherapy With Chemotherapy for Stage I-IIIB Non-Small Cell Lung Cancer Patients

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PD-1 inhibitor
Sponsored by
Peking Union Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ChinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

neoadjuvant PD-(L)1 inhibitor with chemotherapy followed by PD-(L)1 inhibitor for up to 1 year

Arm Description

Outcomes

Primary Outcome Measures

MPR (major pathologic response)
Major pathologic response (MPR) is defined as > 90 percent decrease in viable tumor.

Secondary Outcome Measures

DFS(disease-free survival)
Time from first dose of neoadjuvant treatment to recurrence of tumor or death
OS(overall survival)
Time when the patient is still alive
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

Full Information

First Posted
May 17, 2021
Last Updated
June 24, 2021
Sponsor
Peking Union Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT04941417
Brief Title
Neoadjuvant Immunotherapy With Chemotherapy for Stage I-IIIB Non-Small Cell Lung Cancer Patients
Official Title
Neoadjuvant Immunotherapy With Chemotherapy for the Treatment of Stage I-IIIB Non-Small Cell Lung Cancer (NSCLC): A Phase II Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neoadjuvant PD-(L)1 inhibitor with chemotherapy followed by PD-(L)1 inhibitor for up to 1 year
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PD-1 inhibitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
MPR (major pathologic response)
Description
Major pathologic response (MPR) is defined as > 90 percent decrease in viable tumor.
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
DFS(disease-free survival)
Description
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
Title
OS(overall survival)
Description
Time when the patient is still alive
Time Frame
at 3 years from the first dose of neoadjuvant treatment
Title
Toxicity profile
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junling Li
Phone
861087788713
Email
lijunling@cicams.ac.cn
Facility Information:
Facility Name
China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junling Li, PhD
Phone
+861087788713
Email
lijunling@cicams.ac.cn
First Name & Middle Initial & Last Name & Degree
Puyuan Xing, PhD
Phone
+861087788713
Email
xingpuyuan@cicams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neoadjuvant Immunotherapy With Chemotherapy for Stage I-IIIB Non-Small Cell Lung Cancer Patients

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