Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib

Sponsor
Shanghai Chest Hospital
Study ID
NCT04770688
Phase
PHASE1/PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Osimertinib, 80mg, QD, p.o.
  • Anlotinib — DRUG
    (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.

Study Details

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.

Key Dates

Start date
Nov 19, 2020
Status verified
Aug 2024
Primary completion
Jun 20, 2024
Completion
Jun 20, 2024

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib + Anlotiib
    Escalating doses and expanding doses of Anlotinib administered with Osimertinib

Primary Outcome Measure

Recommended Phase II Dose(RP2D) [ Time Frame: Up to approximately 6 months ]

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