Efficacy and Safety of Concurrent Chemoradiotherapy With Oral Vinorelbine in Patients With Non-small Cell Lung Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Active, not recruiting; Phase 2

Conditions: Vinorelbine

Treatments: Drug: vinorelbine

Study type: Interventional

Funder types: Other

Identifiers

NCT06540950

NCC3690

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Oral vinorelbine concurrent radiotherapy group

Experimental group

Description:

All patients with unresectable stage III non-small cell lung cancer who received neoadjuvant chemo-immunotherapy received oral vinorelbine (60mg per square meter of body-surface area every 2 weeks before radiotherapy, and 30mg per square meter of body-surface area per week during radiotherapy) as radical concurrent chemoratherapy.

Treatment:

Drug: vinorelbine