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

Local Advanced Non-small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888402
• Other study ID #: InTRist
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2022
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Nan Bi, MD
• Phone: 86010-87788799
• Email: binan_email[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age 18-70 years; ECOG score 0-2.

2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).

3. 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.

4. No other previous anti-tumor history, at least 3 months of expected survival.

5. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.

Exclusion Criteria:

1. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.

2. Patients with other active malignancies within 5 years or at the same time.

3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis [except diverticular disease], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome).

4. History of allogeneic organ transplantation.

5. History of active primary immunodeficiency.

6. 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.

7. Women of child-bearing potential who are pregnant or breastfeeding.

8. Allergic to research drug ingredients.

9. Ongoing or prior use of immunosuppressive agents within 14 days prior to first dose

10. The investigator judged other situations not suitable for inclusion in this study.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Local Advanced Non-small Cell Lung Cancer
• Lung Neoplasms

Intervention

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

Radiation:
• Concurrent chemoradiation therapy and consolidation immunotherapy
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.

Locations

Country	Name	City	State
China	Chinese Academy of Medical Science and Peking Union Medical College	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	Defined as the time from recruitment to the date of any documented death due to any cause.	From recruitment to the date of any documented death due to any cause, assessed up to 36 months.
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.	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.