Combining erlotinib with chemotherapy for resistant lung cancer
Second Line Erlitinib Combination With Gemcitabine Cisplatinum in Non-small Cell Lung Cancer Patients Who Harbored EGFR Sensitive Mutation Developed Resistance After First Line TKI Treatment
This study is testing if combining a targeted therapy called erlotinib with chemotherapy can help people with advanced lung cancer who haven't responded to previous treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Drugs / interventions | erlotinib, Crizotinib, chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT02098954 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining erlotinib, a targeted therapy, with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance to prior TKI treatment. The study will enroll patients with EGFR sensitive mutations and perform biopsies to understand the mechanisms of resistance before administering a treatment regimen of gemcitabine and platinum combined with erlotinib. The primary endpoint is to evaluate the mean progression-free survival (PFS), while secondary endpoints include overall survival (OS) and overall response rate (ORR). This approach aims to provide a new treatment option for patients who have limited alternatives due to resistance to existing therapies.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced non-squamous NSCLC who have EGFR sensitive mutations and have developed resistance after first-line TKI treatment.
Not a fit: Patients with squamous cell lung cancer or those with unstable brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with TKI-resistant non-small cell lung cancer.
How similar studies have performed: Previous studies have shown promising results with similar combinations of targeted therapies and chemotherapy in overcoming resistance in lung cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * advanced non-small cell lung cancer, stage IIIB/IV * non-squamous * EGFR sensitive mutations, such as exon 19 del, or exon 21 L858R * received first line TKIs treatment and developed TKI resistance * ECOG 0-2 Exclusion Criteria: * squamous non-small cell lung cancer * patients have unstable brain metastasis, predict survival less than 8 weeks * spinal-cord compression without evidence of stabilisation or treatment * women who were pregnant or lactating; women with a positive or no available pregnancy test result at baseline * patients have any unstable illness that could not receive further treatment
Where this trial is running
Changsha, Hunan
- Hunan Province Tumor Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Nong Yang, MD
- Email: yangnong0217@163.com
- Phone: +86 731 89762323
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.