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A Multicenter, Randomized, Phase II Study of Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Advanced or Locally-advanced Osimertinib-resistant Non-squamous Non-small Cell Lung Cancer (ALTER-L031)

Who is this study for? Patients with advanced or locally-advanced osimertinib-resistant non-squamous non-small cell lung cancer
What treatments are being studied? Pemetrexed+Carboplatin+Anlotinib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Evaluate the efficacy and safety of Anlotinib Hydrochloride in combination with Pemetrexed and Carboplatin versus Pemetrexed and Carboplatin for advanced or locally-advanced Osimertinib-resistant non-squamous non-small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ 1\. 18 Years to 75 Years patients voluntarily participate in this study, signed and dated informed consent with good compliance and follow-up; 2. Confirmed as locally advanced and / or metastatic non-squamous non-small cell lung cancer (NSCLC) by cytology or histology, the diagnosis should be completed at least 6 months after the end of chemotherapy if adjuvant chemotherapy and / or neoadjuvant chemotherapy received (diagnosis based on sputum smear is not accepted) ; 3. Presence of EGFR activating mutations and previously disease progression to Osimertinib (previously treated with 1st / 2nd generation EGFR-TKI or not); 4. At least one target lesion that has accurate measurement by magnetic resonance imaging (MRI) or computed tomography (CT) (conventional CT≥20 mm or spiral CT≥10 mm) in at least 1 direction; 5. Life expectancy is at least 3 months; 6. ECOG PS Scoring: 0\

⁃ 1 point; 8. The main organs function are normally, the following criteria are met:

⁃ Blood routine examination criteria (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli):

⁃ i) hemoglobin (HB) ≥90g/L ii) neutrophil absolute (ANC) ≥1.5×109/L iii) platelet (PLT) ≥80×109/L Biochemical tests meet the following criteria i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.25 ULN or creatinine clearance (CCr)≥45mL/min (Cockcroft-Gault formula).

• Female patients of childbearing age agree that contraceptive measures must be used within the study period and within 8 weeks after the end of the study drug treatment. The serum or urine test indicates unpregnancy within 7 days prior to the study. Male patients agree to have contraceptive use during the study period and within 8 weeks after the end of the study period or have had surgical sterilization.

Locations
Other Locations
China
Caner hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Uninon Medical college
RECRUITING
Shenzhen
Contact Information
Primary
chang J hua, PD
changjianhua@163.com
18017312689
Backup
xiang h wu, dorctor
xhwu2011@yahoo.com
13482888167
Time Frame
Start Date: 2021-11-18
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 105
Treatments
Experimental: Pemetrexed and Carboplatin with Anlotinib
Pemetrexed and Carboplatin with Anlotinib
Active_comparator: Pemetrexed and Carboplatin without Anlotinib
Pemetrexed and Carboplatin without Anlotinib
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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