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

NCT06540950 | Active Not Recruiting Phase 2

• 1 other identifier: NCC3690
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Vinorelbine

Outcome Measures

Primary Outcomes (2)

• Overall survival

  The time between the start of treatment and death from any cause in the one-arm trial

  5 years

• objective response rate

  The ratio of complete response and partial response at 3 months after the end of radiotherapy

  3 months

Study Arms (1)

Oral vinorelbine concurrent radiotherapy group

EXPERIMENTAL

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.

Drug: vinorelbine

Interventions

vinorelbine DRUG

Vinorelbine is administered orally at 60mg per square meter per week by body surface area before radiotherapy and continued to be administered at 30mg per square meter per week during radiotherapy until the end of radiotherapy. Within 6 weeks after the end of radiotherapy, there are no serious side effects, and immune checkpoint inhibitors monotherapy can be performed.

Also known as: oral vinorelbine concurrent chemoradiotherapy

Oral vinorelbine concurrent radiotherapy group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥40 years old.
• Patients must have histologically or cytologically confirmed non-small cell lung cancer.
• ECOG PS was 0 or 1.
• 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.

You may not qualify if:

• History of allogeneic organ transplantation.
• 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 \[granulomatous vasculitis, Graves' disease, rheumatoid arthritis, pituitaritis, uveitis\]).
• 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.
• History of another primary malignancy.
• History of active primary immunodeficiency.
• Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.
• 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.
• Patients who developed ≥ grade 3 pneumonia during study chemoradiotherapy.
• Received any other concurrent chemotherapy, immunotherapy, biotherapy, or hormonal therapy for cancer other than the therapy evaluated in this study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

• Lian X, Shayan G, Yang S, Liu W, Zhang T, Lv J, Wang W, Wang J, Wang X, Xiao Z, Zhou Z, Bi N, Deng L. Efficacy and safety of oral vinorelbine with concurrent radiotherapy in unresectable stage III non-small cell lung cancer following neoadjuvant chemoimmunotherapy: a single-arm, phase 2 trial. J Natl Cancer Cent. 2025 Jul 21;5(6):593-599. doi: 10.1016/j.jncc.2025.06.004. eCollection 2025 Dec.

  PMID: 41497257 DERIVED

MeSH Terms

Interventions

Vinorelbine

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Lei Deng, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: August 7, 2024
• Study Start: March 20, 2023
• Primary Completion: April 10, 2025
• Study Completion (Estimated): June 10, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)