Treatment options for advanced lung cancer with specific genetic mutations

Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.

This study is testing different targeted treatments for people with advanced lung cancer that have specific genetic mutations to see which ones can help them live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hunan Province Tumor Hospital (Academic / other)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT04322890 on ClinicalTrials.gov

What this trial studies

This study evaluates various treatment strategies and their impact on survival outcomes for patients with non-small cell lung cancer (NSCLC) that have specific oncogenic mutations such as EGFR, ALK, ROS1, and MET. Participants will receive targeted therapies including Osimertinib, Alectinib, and Crizotinib, among others, based on their genetic profile. The study aims to determine the effectiveness of these treatments in improving patient survival and quality of life. It involves a comprehensive assessment of treatment responses and side effects in a controlled environment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with Stage IV non-small cell lung cancer and confirmed oncogenic mutations.

Not a fit: Patients who do not have the specified oncogenic mutations or those with earlier stages of lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options and improved survival rates for patients with advanced lung cancer and specific genetic mutations.

How similar studies have performed: Other studies have shown promising results with targeted therapies for similar oncogenic mutations in lung cancer, indicating a potential for success in this approach.

Eligibility criteria

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. Histologically or cytologically confirmed, Stage IV NSCLC.
4. Oncogenic mutations confirmed by an accredited local laboratory, including EGFR, ALK, ROS1 etc.
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.

Exclusion Criteria:

The patient did not match from the Inclusion Criteria.

Where this trial is running

Changsha, Hunan

• Yongchang Zhang — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Yongchang Zhang, MD — Hunan Cancer Hospital
• Study coordinator: Yongchang Zhang, MD

Conditions Non Small Cell Lung Cancer; EGFR Gene Mutation; ALK Gene Mutation; ROS1 Gene Mutation; MET Gene Mutation