Combining Anlotinib and Docetaxel for Advanced Lung Cancer Treatment
Phase II Study to Evaluate the Effectiveness and Safety of Anlotinib Combined With Docetaxel in Progress After First Line Standard Cheomotherapy in Advanced Non-driver Mutation Non- Squamous Non-small Cell Lung Cancer
This study is testing if combining two cancer drugs, Anlotinib and Docetaxel, can help people with advanced lung cancer feel better after their first treatment didn't work.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Drugs / interventions | Anlotinib, chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT03646968 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of Anlotinib combined with Docetaxel in patients with advanced non-squamous non-small cell lung cancer who have progressed after first-line standard chemotherapy. The trial aims to improve the overall response rate (ORR) from the typical 5-8% seen with second-line chemotherapy to an expected 20%. A total of 43 participants will be enrolled based on specific eligibility criteria, including the absence of driver gene mutations. The study will assess how well this combination therapy works in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically proven non-squamous non-small cell lung cancer who have no driver gene mutations and have progressed after first-line chemotherapy.
Not a fit: Patients who have received second-line treatment or have contraindications to chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective second-line therapy option for patients with advanced non-squamous non-small cell lung cancer.
How similar studies have performed: While there have been studies on similar combinations, this specific approach in this patient population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18，Pathologically proven Non squamous non small cell lung cancer * No-drive gene mutaion (EGFR、ALK、ROS1） by NGS * Progress after second line * PS score 0-2 Exclusion Criteria: * Patients received second line treatment * Patients received treatment of Anlotinib or Docetaxel * Patients with contraindication of chemotherapy * Pregnant or breast feeding women
Where this trial is running
Changsha, Hunan
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Yongchang Zhang, MD — Hunan Cancer Hospital
- Study coordinator: Yongchang Zhang, MD
- Email: yangnong0217@163.com
- Phone: +8613873123436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.