Survival Outcomes of Lung Cancer

NCT03647098 | Recruiting

• 1 other identifier: 20180176
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

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

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

Secondary Outcomes (2)

• Overall survival (OS)

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

• Adverse events (AEs)

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

Study Arms (5)

Cohorts 1

Non-small cell lung cancer patients with EGFR mutations. Group A ： Single EGFR Drive gene Mutations Group B ：EGFR co-mutant with De novo MET alterations Group C ：EGFR co-mutant with other genes including ALK , ROS , RET , BRAF .etc

Drug: Treatment

Cohorts 2

Non-small cell lung cancer patients with ALK-fusion positive.

Drug: Treatment

Cohorts 3

Non-small cell lung cancer patients with ROS-1-positive.

Drug: Treatment

Cohorts 4

Non-small cell lung cancer patients with Other Rare Mutations.

Drug: Treatment

Cohorts 5

Driver-negative lung cancer patients with ADC and SQC.

Drug: Treatment

Interventions

Treatment DRUG

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

Cohorts 1; Cohorts 2; Cohorts 3; Cohorts 4; Cohorts 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

lung cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue were obtained with the permission from patients.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yongchang Zhang, MD

  zhangyongchang@csu.edu.cn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Nong Z Yang, MD

CONTACT

+8613055193557; yangnong0217@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Clinical Trial Center

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: August 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)