Survival Outcomes of Lung Cancer

Recruiting

• Conditions: Lung Cancer
• Interventions: Drug: Treatment

• Registration Number: NCT03647098
• Lead Sponsor: Hunan Province Tumor Hospital

Brief Summary

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

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohorts 1	Treatment	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
Cohorts 2	Treatment	Non-small cell lung cancer patients with ALK-fusion positive.
Cohorts 3	Treatment	Non-small cell lung cancer patients with ROS-1-positive.
Cohorts 4	Treatment	Non-small cell lung cancer patients with Other Rare Mutations.
Cohorts 5	Treatment	Driver-negative lung cancer patients with ADC and SQC.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	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 Outcome Measures

Name	Time	Method
Adverse events (AEs)	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
Overall survival (OS)	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)

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China