Analyzing survival outcomes in lung cancer patients

Survival Outcomes for Lung Cancer

This study looks at how different treatment choices affect the survival of lung cancer patients to see which options work best.

Quick facts

• Study type: Observational
• Enrollment: 20000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hunan Province Tumor Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT03647098 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze the survival outcomes of lung cancer patients by assessing different groups based on treatment decisions guided by molecular profiling and the clinical judgment of principal investigators. The study will include patients aged 18 and older with confirmed lung cancer and adequate organ function. Participants will be monitored for their survival outcomes over time, providing valuable data on the effectiveness of various treatment approaches.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histopathologically or cytologically confirmed lung cancer and a predicted survival of at least 12 weeks.

Not a fit: Patients with spinal cord compression, meningeal metastasis, or a history of other malignant tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective treatment strategies for lung cancer, potentially improving patient survival rates.

How similar studies have performed: Other studies analyzing survival outcomes in lung cancer have shown success, indicating that this approach is supported by existing research.

Eligibility criteria

Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial .
2. Age ≥ 18 years.
3. Histopathology or cytology confirmed lung cancer
4. ECOG \<=2.
5. Predicted survival ≥ 12 weeks.
6. Adequate bone marrow hematopoiesis and organ function
7. Presence of measurable lesions according to RECIST 1.1.

Exclusion Criteria:

1. Subjects who have received any of the following treatments must be excluded:

   * Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
   * Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
2. Presence of spinal cord compression or meningeal metastasis.
3. History of other malignant tumors within 2 years.
4. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
5. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
6. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
7. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
8. Heart-related diseases or abnormalities
9. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
10. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb drugs due to previous bowel resection.
11. Live vaccine was given 2 weeks before the first medication.
12. Women who are breastfeeding or pregnant.
13. Hypersensitivity to the test drug and the ingredients.
14. Other conditions assessed by the investigator to be unsuitable for participation in the study.

Where this trial is running

Changsha, Hunan

• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Yongchang Zhang, MD — [e-mail]
• Study coordinator: Yongchang Zhang, MD

Conditions Lung Cancer