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Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume Local Advanced NSCLC (InTRist)

Primary Purpose

Local Advanced Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Concurrent chemoradiation therapy and consolidation immunotherapy
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-70 years; ECOG score 0-2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Unresectable Stage II-III NSCLC (according to AJCC 8th edition) with maximum tumor diameter T ≥ 5 cm in the primary tumor or minimum diameter N ≥ 2 cm in mediastinal metastatic lymph nodes. No other previous anti-tumor history, at least 3 months of expected survival. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function. Exclusion Criteria: Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement. Patients with other active malignancies within 5 years or at the same time. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis [except diverticular disease], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome). History of allogeneic organ transplantation. History of active primary immunodeficiency. Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness. Women of child-bearing potential who are pregnant or breastfeeding. Allergic to research drug ingredients. Ongoing or prior use of immunosuppressive agents within 14 days prior to first dose The investigator judged other situations not suitable for inclusion in this study.

Sites / Locations

  • Chinese Academy of Medical Science and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy

Induction chemotherapy followed by concurrent chemoradiotherapy

Arm Description

Participants will receive 2 cycles of induction therapy of platinum-based chemotherapy combined with Toripalimab, followed by platinum-based concurrent chemoradiation. Then participants will receive Toripalimab consolidation therapy after chemoradiotherapy with maximum 1 years or until disease progression or intolerable toxicity.

Participants will receive 2 cycles of induction platinum-based chemotherapy, followed by platinum-based concurrent chemoradiation. Then participants will receive Toripalimab consolidation therapy after chemoradiotherapy with maximum 1 years or until disease progression or intolerable toxicity.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
Defined as the time from date of recruitment until the date of first documented progression or date of death from any cause, whichever came first.

Secondary Outcome Measures

Overall survival (OS)
Defined as the time from recruitment to the date of any documented death due to any cause.
Adverse Event
The incidence of adverse events (AEs) and serious adverse events (SAEs), evaluated by CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.
Objective Tumour Response (ORR)
The objective tumour response (ORR) will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Disease control rate(DCR)
DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.

Full Information

First Posted
March 18, 2023
Last Updated
August 26, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05888402
Brief Title
Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume Local Advanced NSCLC
Acronym
InTRist
Official Title
The Efficacy and Safety of Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume (Bulky) Local Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a Phase II study to evaluate the clinical efficacy and safety of Toripalimab combined with chemoradiotherapy for large-volume local advanced non-small cell lung cancer
Detailed Description
This study is a Phase II study to evaluate the clinical efficacy and safety of two cycles of induction Toripalimab plus chemotherapy followed by definitive chemoradiotherapy and consolidation Toripalimab therapy for large-volume, unresectable, locally advanced stage II-III non-small cell lung cancer ("large volume" is defined as primary tumor ≥5 cm in greatest dimension or metastatic lymph nodes ≥2 cm in shortest diameter).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Local Advanced 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
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy
Arm Type
Experimental
Arm Description
Participants will receive 2 cycles of induction therapy of platinum-based chemotherapy combined with Toripalimab, followed by platinum-based concurrent chemoradiation. Then participants will receive Toripalimab consolidation therapy after chemoradiotherapy with maximum 1 years or until disease progression or intolerable toxicity.
Arm Title
Induction chemotherapy followed by concurrent chemoradiotherapy
Arm Type
Active Comparator
Arm Description
Participants will receive 2 cycles of induction platinum-based chemotherapy, followed by platinum-based concurrent chemoradiation. Then participants will receive Toripalimab consolidation therapy after chemoradiotherapy with maximum 1 years or until disease progression or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Other Intervention Name(s)
Tuo Yi
Intervention Description
Two cycles of induction Toripalimab (240mg every 3 weeks) plus platinum-based doublet chemotherapy as induction chemoimmunotherapy.
Intervention Type
Radiation
Intervention Name(s)
Concurrent chemoradiation therapy and consolidation immunotherapy
Other Intervention Name(s)
The PACIFIC regimen
Intervention Description
Thoracic radiation therapy (54-66Gy/25-33F/5-7week), concurrently with platinum-based doublet chemotherapy, followed by consolidation Toripalimab (240mg every 3 weeks) as consolidation immunotherapy for up to 12 months.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Defined as the time from date of recruitment until the date of first documented progression or date of death from any cause, whichever came first.
Time Frame
From date of recruitment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Defined as the time from recruitment to the date of any documented death due to any cause.
Time Frame
From recruitment to the date of any documented death due to any cause, assessed up to 36 months.
Title
Adverse Event
Description
The incidence of adverse events (AEs) and serious adverse events (SAEs), evaluated by CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.
Time Frame
AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug, up to 36 months.
Title
Objective Tumour Response (ORR)
Description
The objective tumour response (ORR) will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame
Tumor assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from recruitment until objective progression or death from any cause, assessed up to 36 months.
Title
Disease control rate(DCR)
Description
DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.
Time Frame
Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause, assessed up to 36 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-70 years; ECOG score 0-2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Unresectable Stage II-III NSCLC (according to AJCC 8th edition) with maximum tumor diameter T ≥ 5 cm in the primary tumor or minimum diameter N ≥ 2 cm in mediastinal metastatic lymph nodes. No other previous anti-tumor history, at least 3 months of expected survival. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function. Exclusion Criteria: Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement. Patients with other active malignancies within 5 years or at the same time. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis [except diverticular disease], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome). History of allogeneic organ transplantation. History of active primary immunodeficiency. Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness. Women of child-bearing potential who are pregnant or breastfeeding. Allergic to research drug ingredients. Ongoing or prior use of immunosuppressive agents within 14 days prior to first dose The investigator judged other situations not suitable for inclusion in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Bi, MD
Phone
86010-87788799
Email
binan_email@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan Bi, MD
Organizational Affiliation
Chinese Academy of Medical Science and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Science and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Bi, MD, PhD
Email
binan_email@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume Local Advanced NSCLC

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