Clinical trial NCT06540950: Efficacy and Safety of Concurrent Chemoradiotherapy With Oral Vinorelbine in Patients With Non-small Cell Lung Cancer
Official title: Study of Oral Vinorelbine Single Drug Concurrent Chemoradiotherapy and Immune-maintenance Therapy in Patients With Unresectable Stage III Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Vinorelbine
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 47
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of concurrent chemoradiotherapy with oral vinorelbine, and immune maintenance therapy in patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy, with a view to providing an effective treatment regimen for these patients.

Detailed description: Patients with unresectable stage III non-small cell lung cancer after neoadjuvant chemo-immunotherapy are enrolled to receive concurrent chemoradiotherapy with oral vinorelbine, and immune-maintenance therapy. The primary endpoint is objective response rate, and secondary endpoints include disease control rate, progression-free survival, compliance and safety.

Eligibility criteria: Inclusion Criteria:

1. Age ≥40 years old.
2. Patients must have histologically or cytologically confirmed non-small cell lung cancer.
3. ECOG PS was 0 or 1.
4. Adequate organ and bone marrow function is present. Absolute neutrophil counts, platelet counts, and hemoglobin criteria must not be met after blood transfusion or growth factor support within 14 days prior to randomization.

Exclusion Criteria:

1. History of allogeneic organ transplantation.
2. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease \[Colitis or Crohn's disease\], diverticulitis \[other than diverticulitis\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \[granulomatous vasculitis, Graves' disease, rheumatoid arthritis, pituitaritis, uveitis\]).
3. There is uncontrolled serious underlying diseases, including active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, active interstitial lung disease, and severe chronic gastrointestinal disease.
4. History of another primary malignancy.
5. History of active primary immunodeficiency.
6. Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.
7. For any unmitigated toxicity during pre-study chemoradiotherapy. Patients who develop irreversible toxicity and are reasonably expected not to worsen after study treatment (such as hearing loss) may enter the study after consultation with the study physician.
8. Patients who developed ≥ grade 3 pneumonia during study chemoradiotherapy.
9. Received any other concurrent chemotherapy, immunotherapy, biotherapy, or hormonal therapy for cancer other than the therapy evaluated in this study.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: objective response rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Lei Deng, MD
role: STUDY_CHAIR
References: