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

NCT05888402 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: InTRist
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

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: Toripalimab; Radiation: 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

Concurrent chemoradiation therapy and consolidation immunotherapy RADIATION

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.

Also known as: The PACIFIC regimen

Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy; Induction chemotherapy followed by concurrent chemoradiotherapy

Toripalimab DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Shanghai Junshi Bioscience Co., Ltd.: collaborator

Study Sites (1)

Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

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: 38288117 DERIVED

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
• Primary Completion: October 8, 2024
• Study Completion: March 20, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)