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NCT Number: NCT03647098

Survival Outcomes of Lung Cancer

This is a prospective study to analyze the survival outcomes of different groups about lung cancer patients.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

treatment

Drug

Treatment decisions guided by molecular profiling and clinical judgment of principal investigators

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: Time from first subject dose to study completion, or up to 5 years

    PFS defines as first dose to first documented disease progression assessed by investigator or death due to any cause.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Time from first subject dose to study completion, or up to 5 years

    To assess overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)

  2. Adverse events (AEs)

    Time frame: Time from first subject dose to study completion, or up to 5 years

    Number of participants with adverse events (AEs) according to CTCAE 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Nong Z Yang, MD

CONTACT

[email protected]

+8613055193557 ext. +8613873123436

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. +8613873123436

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

Survival Outcomes for Lung Cancer

Acronym: Soul

Important dates

Study start
2018
Primary completion
2028
Study completion
2030
First posted
Aug 27, 2018
Registry last updated
Feb 14, 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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