Stage II-III Non-small Cell Lung CancerNCT06958614
Prophylactic PEG-rhG-CSF During cCRT in LA-NSCLC
An observational study of Stage II-III Non-small Cell Lung Cancer and Concurrent Chemotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stage II-III Non-small Cell Lung Cancer, Concurrent Chemotherapy, Conditions Influencing Health Status
- What is being tested?
- Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor
- How many people
- 213 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2019to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Definitive Concurrent Chemoradiotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer，Patients received prophylactic PEG-rhG-CSF 48 hours after chemotherapy.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
About this study
Official 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
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) .
Read more
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.
- Conditions
- Stage II-III Non-small Cell Lung Cancer, Concurrent Chemotherapy, Conditions Influencing Health Status
- Being tested
- Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor
- Keywords
- Pegylated recombinant human granulocyte colony-stimulating factor, Non-small cell lung cancer, concurrent chemoradiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating FactorDrug
The experimental group received prophylactic PEG-rhG-CSF 48 hours after chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 or more (G3+) neutropenia
According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale
Measured: From the first day of radiotherapy to one month after the end of radiotherapy
Secondary outcomes (6)
treatment delays
Chemotherapy delay
Measured: Chemotherapy delay was defined as a delay of ≥7 days
interruptions
Radiotherapy interruption
Measured: Break in radiotherapy of ≥3 days
G3+ thrombocytopenia and anemia
According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale
Measured: From the first day of radiotherapy to one month after the end of radiotherapy
G2+ acute radiation esophagitis (RE) and pneumonitis (RP)
According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale
Measured: From the first day of radiotherapy to six month after the end of radiotherapy
progression-free survival (PFS)
the time from the start of cCRT to the first event of disease progression
Measured: assessed up to 72 months
overall survival (OS)
the time from the start of cCRT to death from any cause
Measured: assessed up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start2 Sep 2019
- Primary completion7 Nov 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II-III Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIANYANG WANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958614
- Sponsor's protocol ID
- 19/216-2000
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06958614
- Acronym / sponsor ID
- 19/216-2000
- Conditions
- Stage II-III Non-small Cell Lung Cancer, Concurrent Chemotherapy, Conditions Influencing Health Status
- Keywords
- Pegylated recombinant human granulocyte colony-stimulating factor, Non-small cell lung cancer, concurrent chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Definitive Concurrent Chemoradiotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer，Patients received prophylactic PEG-rhG-CSF 48 hours after chemotherapy.
Key inclusion criteria (14 listed)
- Diagnosis
- Treatment Plan
- Demographics
- Performance Status
- Organ Function
Key exclusion criteria (11 listed)
- Active Malignancies
- Infectious/Immunological Conditions
- Hypersensitivity Reactions
- Neuropsychiatric Impairments
- Prior Radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating FactorThe experimental group received prophylactic PEG-rhG-CSF 48 hours after chemotherapy | Drug | – |
Primary outcome
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
6 secondary outcomes
treatment delays
Time frame: Chemotherapy delay was defined as a delay of ≥7 days
interruptions
Time frame: Break in radiotherapy of ≥3 days
G3+ thrombocytopenia and anemia
Time frame: From the first day of radiotherapy to one month after the end of radiotherapy
G2+ acute radiation esophagitis (RE) and pneumonitis (RP)
Time frame: From the first day of radiotherapy to six month after the end of radiotherapy
progression-free survival (PFS)
Time frame: assessed up to 72 months
overall survival (OS)
Time frame: assessed up to 72 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage II-III Non-small Cell Lung Cancer and Concurrent Chemotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3 or more (G3+) neutropenia (time frame: From the first day of radiotherapy to one month after the end of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.