Recruiting NCT03647098
Survival Outcomes of Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Survival Outcomes for Lung Cancer
Overview
This is a prospective study to analyze the survival outcomes of different groups about lung cancer patients.
Detailed description
This study aims to analyze the survival outcomes of different groups about lung cancer patients. All the groups were assessed to the treatment decisions guided by molecular profiling and clinical judgment of principal investigators
Interventions
- Drug Treatment
Treatment decisions guided by molecular profiling and clinical judgment of principal investigators
Primary outcome measures
- Progression-free survival (PFS) [Time frame: Time from first subject dose to study completion, or up to 5 years]
Secondary outcome measures (2)
- Overall survival (OS) [Time frame: Time from first subject dose to study completion, or up to 5 years]
- Adverse events (AEs) [Time frame: Time from first subject dose to study completion, or up to 5 years]
Eligibility criteria
Inclusion criteria
- Understand the requirements and contents of the clinical trial .
- Age ≥ 18 years.
- Histopathology or cytology confirmed lung cancer
- ECOG <=2.
- Predicted survival ≥ 12 weeks.
- Adequate bone marrow hematopoiesis and organ function
- Presence of measurable lesions according to RECIST 1.1.
Exclusion criteria
- 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.
- Presence of spinal cord compression or meningeal metastasis.
- History of other malignant tumors within 2 years.
- 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.
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
- 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.
- Heart-related diseases or abnormalities
- 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.
- Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb drugs due to previous bowel resection.
- Live vaccine was given 2 weeks before the first medication.
- Women who are breastfeeding or pregnant.
- Hypersensitivity to the test drug and the ingredients.
- Other conditions assessed by the investigator to be unsuitable for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Hunan Cancer Hospital — Changsha
Identifiers
NCT: NCT03647098 · 20180176