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Apatinib

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Phase 1 study of Apatinib in combination with platinum-based doublet chemotherapy.

Phase 1 study of Apatinib in combination with platinum-based doublet chemotherapy(PBDC).

Phase 2 study of Apatinib in combination with platinum-based doublet chemotherapy(PBDC).

Pemetrexed/Cisplatin(AP) or Pemetrexed/Carboplatin(AC), The platinum-based doublet chemotherapy, as the control group in the phase 2 study.

Doses to be determined following the completion of Phase I of the study.

Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.

AP or AC

Apatinib 250mg

Apatinib 500mg

Apatinib 750mg

You Lu, MD

Meijuan Huang, MD

The purpose of this study is to evaluate the safety and clinical activity of Apatinib in combination with AP(Pemetrexed/Carboplatin) or AC(Pemetrexed/Carboplatin) as first-line chemotherapy in subjects with advanced EGFR wild type non-squamous non-small cell lung cancer(NSCLC).

Apatinib, an oral highly potent tyrosine-kinase inhibitor targeting VEGFR-2, has demonstrated improved survival in previously treated patients with advanced non-small-cell lung cancer(NSCLC).

The phase I study is conducted to explore the safety, tolerability, dose-limiting toxicities(DLT), Maximum Tolerable Dose(MTD), and preliminary anti-tumor activity of Apatinib combined with platinum-based doublet chemotherapy(PB-DC) in first-line advanced EGFR wild type non-squamous non-small cell lung cancer. This will use a dose reduction trial design. A cohort of 3\~6 subjects will be enrolled at each dose level, If 0 of 3 or ≤ 1 of 6 subjects experience a DLT, the phase I trial will stop and the current dose will be considered the MTD. If 1 of 6 or more subjects experiences a DLT, dose reduce to the next dose will occur.

Following completion of the dose de-escalation trial and determination of MTD, A randomized controlled trial(RCT) including 30 subjects may be enrolled to further evaluate safety, tolerability, and preliminary anti-tumor activity of Apatinib in combination with platinum-based doublet chemotherapy(PB-DC) in the same target population.

Apatinib Combine With Platinum-Based Doublet Chemotherapy for First-line Treatment of Advanced NSCLC

A Phase 1/2 Study of Apatinib in Combination With AP(Pemetrexed/Cisplatin) or AC(Pemetrexed/Carboplatin) as First-line Chemotherapy for Advanced Epidermal Growth Factor Receptor(EGFR) Wild Type Non-squamous Non-small Cell Lung Cancer

To determine ORR of Apatinib in combination with AP or AC in subjects with advanced EGFR wild type non-squamous non-small cell lung cancer. ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

median Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.

Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group.

Jiangsu HengRui Medicine Co., Ltd.

West China Hospital

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Oxaliplatin

Camrelizumab

S-1, Oxaliplatin

Zhenggang Zhu

The study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer

Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Multicenter, Randomized Phase II-III Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Apatinib Combine With Platinum-Based Doublet Chemotherapy for First-line Treatment of Advanced NSCLC	NCT03201146	Lung Cancer Non Small Cell ... Combination Che... Apatinib	Apatinib AP or AC Apatinib 250mg Apatinib 500mg Apatinib 750mg	18 Years - 70 Years	West China Hospital
Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer	NCT04208347	Gastric and Gas...	Apatinib 250mg Camrelizumab S-1, Oxaliplati... Apatinib 500mg	18 Years - 75 Years	Ruijin Hospital

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