Study of Anlotinib Combined With Osimertinib as Second-line Treatment in Stage IIIb-IV NSCLC With Confirmed EGFRm and T790M

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT04029350
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Anlotinib Combined With Osimertinib — DRUG
    Anlotinib：12mg/capsule, take once when limosis in the morning. If patients suffer from AEs, they can get declined dosage (10mg or 8mg). Osimertinib：80 mg/tablet， per os (p.o.) daily. It should be continued until disease progression or intolerable toxicity or patients withdraw of consent.

Study Details

Evaluate the efficacy and safety of Anlotinib combined with Icotinib as the second-line treatment in stage IIIb-IV NSCLC patients with sensitive EGFR and T790M mutations.

Key Dates

Start date
Jul 31, 2019
Status verified
Jun 2019
Primary completion
Jan 31, 2020
Completion
Nov 30, 2021

Study Design

Enrollment
53 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anlotinib Combined With Osimertinib
    Anlotinib 12 mg once a day from day 1 to 14 of a 21-day cycle. Osimertinib 80mg p.o, qd. It should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: each 42 days up to PD or death (up to 24 months) ]

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