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Completed

NCT Number: NCT06958614

Prophylactic PEG-rhG-CSF During cCRT in LA-NSCLC

Objective: To evaluate the efficacy and safety of prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) during definitive concurrent chemoradiotherapy (cCRT) in patients with inoperable stage II-III non-small cell lung cancer (NSCLC).

Methods: A prospective observational cohort study was conducted on patients receiving definitive cCRT. The radiation therapy technique uses intensity modulated radiation therapy (IMRT) and involves field irradiation. It protects more normal tissue from exposure.Chemotherapy regimens included platinum-based doublet combinations: etoposide plus cisplatin (every 28 days), pemetrexed plus platinum (every 21 days), or paclitaxel plus platinum (weekly, only for control group) .

Patients were followed up at one month post-treatment, then every three months for the two year, and every six months thereafter until disease progression.

In the study group, patients received subcutaneous injections of PEG-rhG-CSF (6 mg for patients weighing ≥45 kg, 3 mg for patients <45 kg) 48 hours after each chemotherapy cycle during cCRT. In the control group, patients received guideline-based supportive treatment. Radiotherapy was halted or chemotherapy was delayed when grade 3 or more (G3+) toxicities happened.

Endpoints:Primary endpoint was incidence of G3+ neutropenia during radiotherapy and one month post-radiotherapy. Complete blood counts were monitored weekly during cCRT and for one month post-treatment or as deemed necessary by the physician.

Following the completion of cCRT and the resolution of acute side effects, patients were followed up at one month post-treatment, then every three months for the first year, and every six months thereafter until disease progression.

Statistical Analysis:The inverse probability of treatment weighting (IPTW) algorithm was applied to balance differences between groups in terms of age, gender, smoking, clinical stage, KPS score, induction therapy received or not, ensuring the reliability of the study results. Statistical analysis was performed using R software (version 4.4.1). All tests were two-sided, with a P-value <0.05 considered statistically significant.

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Key information

Conditions

Stage II-III Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Concurrent Chemotherapy Conditions Influencing Health Status Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis
  • Histologically confirmed stage II-III non-small cell lung cancer (NSCLC)
  • Treatment Plan
  • Planned to receive concurrent platinum-based chemotherapy with radiotherapy (cCRT)
  • Demographics
  • Age 18-80 years
  • Performance Status
  • Karnofsky Performance Status (KPS) ≥70
  • Organ Function
  • Renal function: Creatinine clearance ≥60 mL/min
  • Hepatic function: Total bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN
  • Absolute neutrophil count ≥2.0×10⁹/L
  • Platelets ≥100×10⁹/L
  • Hemoglobin ≥10 g/dL

Exclusion criteria

  • Active Malignancies
  • Concurrent diagnosis of active malignancies (excluding: non-melanoma skin cancer, carcinoma in situ, or malignancies in complete remission for ≥5 years)
  • Infectious/Immunological Conditions
  • Active systemic infection requiring intravenous antimicrobial therapy
  • Uncontrolled autoimmune diseases (defined as requiring systemic immunosuppressants at doses >10 mg/day prednisone equivalent within 30 days prior to screening)
  • Hypersensitivity Reactions
  • Allergy to PEG-rhG-CSF or other biological products derived from genetically engineered Escherichia coli
  • Neuropsychiatric Impairments
  • Severe psychiatric disorders (e.g., schizophrenia, major depressive disorder with suicidal ideation) requiring hospitalization within 6 months)
  • Prior Radiotherapy
  • History of thoracic radiotherapy involving >30% lung parenchyma or mean heart dose >20 Gy

Treatment and study plan

Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor

Drug

The experimental group received prophylactic PEG-rhG-CSF 48 hours after chemotherapy

Primary outcomes

  1. Grade 3 or more (G3+) neutropenia

    Time frame: From the first day of radiotherapy to one month after the end of radiotherapy

    According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale

Secondary outcomes

  1. treatment delays

    Time frame: Chemotherapy delay was defined as a delay of ≥7 days

    Chemotherapy delay

  2. interruptions

    Time frame: Break in radiotherapy of ≥3 days

    Radiotherapy interruption

  3. G3+ thrombocytopenia and anemia

    Time frame: From the first day of radiotherapy to one month after the end of radiotherapy

    According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale

  4. G2+ acute radiation esophagitis (RE) and pneumonitis (RP)

    Time frame: From the first day of radiotherapy to six month after the end of radiotherapy

    According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale

  5. progression-free survival (PFS)

    Time frame: assessed up to 72 months

    the time from the start of cCRT to the first event of disease progression

  6. overall survival (OS)

    Time frame: assessed up to 72 months

    the time from the start of cCRT to death from any cause

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Efficacy and Safety of Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor During Definitive Concurrent Chemoradiotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer: A Prospective Cohort Study

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
May 6, 2025
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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