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Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib

NCT04770688 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-08-15

No results posted yet for this study

Summary

This is a prospective, single arm, phase Ib/IIa study. Up to 25 patients will be enrolled into the study (Part A: 2-18; Part B: 7-19). The study has been designed to allow an investigation of the optimal combination dose and schedule whilst of Osimertinib plus Anlotinib in patients with EGFRm+, treatment-naïve IIIb/IV Non-Small Cell Lung Cancer (NSCLC) ensuring the safety of patients with intensive safety monitoring. There are two main parts to this study; Part A, Combination dose finding and Parts B, Dose expansion.

Conditions

  • Non-Small Cell Lung Cancer With EGFR Mutation
  • Locally Advanced Solid Tumor
  • Metastatic Cancer
  • Adenocarcinoma of Lung

Interventions

DRUG

Osimertinib

Osimertinib, 80mg, QD, p.o.

DRUG

Anlotinib

(Phase Ib) Anlotinib, from 8mg to10mg to 12mg, QD, p.o. from day 1 to 14 of a 21-day cycle. (Phase IIa)Anlotinib, given at RP2D dose QD, p.o. from day 1 to 14 of a 21-day cycle.

Sponsors & Collaborators

  • Shanghai Chest Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2024-06-20
Completion
2024-06-20

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04770688 on ClinicalTrials.gov