Analysis of Survival Status of KRAS Mutation Advanced Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

— KILLER  

Official title:

Analysis of Survival Status of KRAS Mutation Advanced Non-small Cell Lung Cancer Based on NGS Test Results in Hunan Province, China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03647098
• Other study ID #: 20180176
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: December 1, 2028

Study information

• Verified date: May 2024
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to analyze the survival condition of different groups about non-small cell lung cancer patients with KRAS mutations. These groups are made according to the treatment regime, brain metastases and KRAS alterations.

Description:

This study aims to analyze the survival condition of different groups about non-small cell lung cancer patients with KRAS mutations. These groups are made according to the treatment regime, brain metastases and KRAS alterations.

All the groups were assessed to chemotherapy, chemotherapy plus immunotherapy, clinical trials etc.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 1, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.

2. Age = 18 years.

3. Histopathology or cytology confirmed metastatic non-small cell lung cancer without systemic treatment.

4. KRAS mutations confirmed by an accredited local laboratory.

5. ECOG 0 - 1.

6. Predicted survival = 12 weeks.

7. Adequate bone marrow hematopoiesis and organ function

8. Presence of measurable lesions according to RECIST 1.1.

9. Subjects with stable brain metastases may be included in the study.

Exclusion Criteria:

1. Prior systemic therapy for locally advanced or metastatic disease.

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

• Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.

• 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.

3. Presence of spinal cord compression or meningeal metastasis.

4. History of other malignant tumors within 2 years.

5. 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.

6. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.

7. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.

8. 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.

9. Heart-related diseases or abnormalities

10. 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.

11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.

12. Live vaccine was given 2 weeks before the first medication.

13. Women who are breastfeeding or pregnant.

14. Hypersensitivity to the test drug and the ingredients.

15. Other conditions assessed by the investigator to be unsuitable for participation in the study.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• KRAS G12D
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Chemotherapy.
pemetrexed, 500mg/m2, ivgtt every 21 day.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	To assess overall survival, define as first dose to the death of the subject due to any cause.	Time from first subject dose to study completion, or up to 36 months.
Secondary	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 36 months.