Last reviewed · How we verify
NCT06958614
Prophylactic PEG-rhG-CSF During cCRT in LA-NSCLC
trial testing Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor in Stage II-III Non-small Cell Lung Cancer in 213 participants. Completed in 30 January 2025.
7 November 2024
Quick facts
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 213 |
| Start date | 2 September 2019 |
| Primary completion | 7 November 2024 |
| Estimated completion | 30 January 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor — full drug profile →
Conditions studied
- Stage II-III Non-small Cell Lung Cancer — all drugs for Stage II-III Non-small Cell Lung Cancer →
- Concurrent Chemotherapy — all drugs for Concurrent Chemotherapy →
- Conditions Influencing Health Status — all drugs for Conditions Influencing Health Status →
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Who can join
Adults 18 to 80, any sex, with Stage II-III Non-small Cell Lung Cancer or Concurrent Chemotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06958614
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Stage II-III Non-small Cell Lung Cancer
Currently open trials in the same condition.
- NCT07131163 — Real World Stage II-III NSCLC Patients Receiving Neoadjuvant Chemo-immunotherapy and no Surgical Resection · recruiting
- NCT04158440 — Phase III Study of Toripalimab Versus Placebo Plus Chemotherapy in Resectable NSCLC · Phase 3 · active not recruiting
Other Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials
Trials by the same sponsor.
- NCT07531563 — Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy · NA · not yet recruiting
- NCT07537049 — BR101 in Patients With Relapsed/Refractory Multiple Myeloma · Phase 1 · not yet recruiting
- NCT07187154 — The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy · NA · not yet recruiting
- NCT07530549 — A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Che · Phase 2 · not yet recruiting
- NCT07507058 — Hypofractionated Radiotherapy for Postoperative Intermediate-Risk Head and Neck Squamous Cell Carcinoma · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06958614 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Last refreshed: 6 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06958614.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing