A Phase 2 interventional study of Anlotinib Hydrochloride and Lobaplatin in Small Cell Lung Carcinoma, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-29.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Phase 2, Interventional, and Treatment
This is a prospective, randomized, open-label and active controlled phase II study. It plans to enroll 60 subjects with extensive stage small cell lung cancer (ES-SCLC). All subjects will be assigned randomly to the experimental arm or control arm. The primary endpoints would be overall survival and progression-free survival.
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy.
SCLC has a more abundant vascular network than NSCLC. Anti-tumor vascular therapy combined with chemotherapy is considered the most promising SCLC first-line anti-tumor strategy. Anlotinib Hydrochloride has an anti-angiogenic effect and inhibits tumor's growth. It has been reported that Anlotinib has the dual benefits of both overall survival and progression-free survival in the treatment of multiple tumors, and has initially demonstrated its safety and efficacy. The ALTER 0303 study results showed that Anlotinib benefited both the overall and progression-free survival of NSCLC patients. However, there is no clinical study to probe its relevance to small cell lung cancer, and few studies have examined the status of Anlotinib in first-line treatment.
This randomized, open-label, controlled study is to evaluate the efficacy and safety of sequential EL regimen with Anlotinib hydrochloride as first-line treatment for extensive-stage SCLC. The study plan to enroll 60 ES-SCLC subjects and will provide evidence for the use of Anlotinib for SCLC first-line treatment.
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's planned enrollment of 60 is close to the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment);
Exclusion Criteria:
EL regimen for 4 cycles followed by Anlotinib Hydrochloride maintenance therapy
Drug: Anlotinib Hydrochloride · Drug: Lobaplatin · Drug: Etoposide
EL regimen for 4 cycles
Drug: Lobaplatin · Drug: Etoposide
Anlotinib: Maintenance therapy 12mg/day P.O., day 1-15 every 21 days (2 weeks on, 1 week off) until progressive disease or treatment discontinuation
Also known as: AL3818
Lobaplatin:30 mg/m2 IV every 21 days for up to 4 cycles of 21 days
Also known as: D-19466
Etoposide: 60 mg/m2 IV every 21 days for up to 4 cycles of 21 days
Also known as: VP16
Progression Free Survival Time
Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.
Time frame: Time from randomization to first documented progression, assessed for up to 2 years
Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)
Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.
Time frame: Up to 2 years
Overall Survival
Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.
Time frame: Time from randomization to death by any cause, assessed for up to 3 years
Percentage of Participants Experiencing an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered study treatment which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure
Time frame: Up to 2 years
Plan to share: Undecided
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The First Affiliated Hospital of Guangzhou Medical University