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Trial Title:
Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume Local Advanced NSCLC
NCT ID:
NCT05888402
Condition:
Local Advanced Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Immunomodulating Agents
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Two cycles of induction Toripalimab (240mg every 3 weeks) plus platinum-based doublet
chemotherapy as induction chemoimmunotherapy.
Arm group label:
Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy
Other name:
Tuo Yi
Intervention type:
Radiation
Intervention name:
Concurrent chemoradiation therapy and consolidation immunotherapy
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.
Arm group label:
Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy
Arm group label:
Induction chemotherapy followed by concurrent chemoradiotherapy
Other name:
The PACIFIC regimen
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).
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese Academy of Medical Science and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Nan Bi, MD, PhD
Email:
binan_email@163.com
Start date:
May 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Shanghai Junshi Bioscience Co., Ltd.
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05888402
