Who is sponsoring NCT02824458?

NCT02824458 is sponsored by Sun Yat-sen University.

What condition does NCT02824458 study?

NCT02824458 studies EGFR Tyrosine Kinase Inhibitors Plus VEGFR Inhibitors.

What drugs are being tested in NCT02824458?

Interventions: Apatinib, Gefitinib, Placebo.

What is the status of NCT02824458?

NCT02824458 is currently UNKNOWN.

Last reviewed 2016-07-06 · How we verify

A Multicenter, Randomized,Double-Blind Study of Gefitinib in Combination With Apatinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-squamous Non-Small-Cell Lung Cancer

NCT02824458 Phase 3 UNKNOWN

The main purpose of this study is to evaluate the safety and efficacy of Apatinib in combination with Gefitinib as compared to placebo in combination with Gefitinib in participants with stage ⅢB-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B).

Details

Lead sponsor	Sun Yat-sen University
Phase	Phase 3
Status	UNKNOWN
Enrolment	246
Start date	2016-06
Completion	2023-12

Conditions

EGFR Tyrosine Kinase Inhibitors Plus VEGFR Inhibitors

Interventions

Apatinib
Gefitinib
Placebo

Primary outcomes

(Part A) Determine Dose-Limiting Toxicity (DLT) of Apatinib in combination with Gefitinib — 1 months
Determine the safety, tolerability and DLTs of Apatinib in Combination With Gefitinib
(Part A) Maximum Tolerated Dose (MTD) of Apatinib in Combination With Gefitinib — 1 months
MTD was determined by testing increasing doses up to 750 mg daily (qd) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets \< 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); CTC Version 2 were used.
(Part B) Progression Free Survival (PFS) — Randomization to Measured Progressive Disease or Death from Any Cause (Estimated as 42 Months)
Time from the date of enrolment until documented progression or death, whichever occurs first.

Countries

China