Non-squamous Non-small-cell Lung Cancer
Conditions
Brief summary
This study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. The primary endpoint of the study is progression-free survival (PFS); the secondary endpoints are disease control rate (DCR), objective response rate (ORR) and overall survival (OS).
Interventions
DRUGAnlotinib + Pemetrexed+Carboplatin
Anlotinib: 12mg, QD, PO, d1-14, 21 days per cycle Carboplatin: AUC 5 on day 1 of 21 days per cycle Pemetrexed: 500mg/m2 iv on day 1 of 21 days per cycle
DRUGPemetrexed
500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
DRUGAnlotinib + Pemetrexed
Anlotinib:12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase) Pemetrexed:500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
DRUGAnlotinib
12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years and ≤ 75, ECOG PS: 0\ 1, estimated survival duration more than 3 months; 2. Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC; 3. Signed and dated informed consent; 4. adequate hematological, liver and renal function
Exclusion criteria
1. prior chemotherapy or treatment with another systemic anti-cancer agent 2. malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS 3. evidence of tumor invading major blood vessels 4. current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes 5. history of haemoptysis \>/=grade 2 6. clinically significant cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 6 months | PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | each 42 days up to intolerance the toxicity or PD (up to 12 months) | Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR). |
| Disease control rate (DCR) | each 42 days up to intolerance the toxicity or PD (up to 12 months) | Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR). |
| Overall Survival (OS) | 12 months | OS is calculated from diagnosis to death or last follow-up time. |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Until 30 day safety follow-up visit | Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
Contacts
Primary ContactRenhua Guo, MD
Outcome results
None listed