Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations

Sponsor
Li Zhang, MD
Study ID
NCT04695925
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • EGFR Gene Mutation
  • Non-small Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    Osimertinib, 80mg, QD, p.o. until disease progression
  • Pemetrexed — DRUG
    pemetrexed 500 mg/m2 intravenously every 3 weeks until disease progression
  • Carboplatin — DRUG
    carboplatin area under curve 5 intravenously every 3 weeks for four cycles

Study Details

This is a phase III randomized trial in patients with advanced non-squamous NSCLC harboring EGFR-sensitizing mutations and concurrent TP53 mutations with a performance status of 0 to1 who are planned to receive first-line therapy.

Key Dates

Start date
Mar 29, 2021
Status verified
Oct 2025
Primary completion
Nov 1, 2025
Completion
Dec 30, 2027

Study Design

Enrollment
294 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: osimertinib monotherapy
    Osimertinib, 80mg, QD, p.o. until disease progression
  • Experimental: combination of osimertinib and chemotherapy
    Osimertinib, 80mg, QD, p.o. Pemetrexed 500 mg/m2 and carboplatin area under curve 5 intravenously every 3 weeks for four cycles, followed by maintenance pemetrexed.

Primary Outcome Measure

progression free survival [ Time Frame: assessed up to 36 months ]

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