Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume Local Advan… (NCT05888402) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume Local Advanced NSCLC
China50 participantsStarted 2023-01-20
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Progression-free survival (PFS)
Timeframe: 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.
Trial details
NCT IDNCT05888402
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences