Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Phase 2
Started
2023-01-20
Last updated
2026-02-27
Condition(s) studied
Local Advanced Non-small Cell Lung Cancer
Investigational drug(s) / intervention(s)
Toripalimab →Concurrent chemoradiation therapy and consolidation immunotherapy
Toripalimab: Two cycles of induction Toripalimab (240mg every 3 weeks) plus platinum-based doublet chemotherapy as induction chemoimmunotherapy.
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.
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-75 years; ECOG score 0-1.
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.
Primary outcome measure(s)
Progression-free survival (PFS) — 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. 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.
Trial sites (1)
Facility
City
Region
Status
Chinese Academy of Medical Science and Peking Union Medical College
Beijing
Beijing Municipality
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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