Trials Sponsors Conditions Drugs Pricing

Conditions

Local Advanced Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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.
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 Outcomes (4)

Overall survival (OS）
From recruitment to the date of any documented death due to any cause, assessed up to 36 months.
Adverse Event
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.
Objective Tumour Response (ORR)
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.
Disease control rate（DCR）
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.

Study Arms (2)

Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy

EXPERIMENTAL

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.

Drug: ToripalimabRadiation: Concurrent chemoradiation therapy and consolidation immunotherapy

Induction chemotherapy followed by concurrent chemoradiotherapy

ACTIVE COMPARATOR

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.

Radiation: Concurrent chemoradiation therapy and consolidation immunotherapy

Interventions

ToripalimabDrug

Two cycles of induction Toripalimab (240mg every 3 weeks) plus platinum-based doublet chemotherapy as induction chemoimmunotherapy.

Also known as: Tuo Yi

Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy

Concurrent chemoradiation therapy and consolidation immunotherapyRadiation

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.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18-75 years; ECOG score 0-1.
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).

Sponsors & Collaborators

Shanghai Junshi Bioscience Co., Ltd.
Othercollaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Otherlead

Study Sites (1)

Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Related Publications (1)

Wang Y, Deng L, Wang J, Zhang T, Wang W, Wang X, Liu W, Wu Y, Lv J, Feng Q, Zhou Z, Wang J, Wang L, Wang Z, Bi N. Induction PD-1 inhibitor toripalimab plus chemotherapy followed by concurrent chemoradiotherapy and consolidation toripalimab for bulky locally advanced non-small-cell lung cancer: protocol for a randomized phase II trial (InTRist study). Front Immunol. 2024 Jan 15;14:1341584. doi: 10.3389/fimmu.2023.1341584. eCollection 2023.
PMID: 38288117DERIVED

MeSH Terms

Interventions

toripalimab

Study Officials

Nan Bi, MD
Chinese Academy of Medical Science and Peking Union Medical College
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 18, 2023

First Posted

June 5, 2023

Study Start

January 20, 2023

Actual (reported)

Primary Completion

October 8, 2024

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy

Induction chemotherapy followed by concurrent chemoradiotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy

Induction chemotherapy followed by concurrent chemoradiotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations