Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC

Sponsor
AstraZeneca
Study ID
NCT05215951
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • osimertinib — DRUG
    Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration

Study Details

This is an open-label, single-arm, multicenter, exploratory Phase II study sponsored by Astrazeneca Investment (China) Co., LTD. to evaluate the efficacy and safety of Osimertinib with Platinum plus Pemetrexed Chemotherapy, as First-line Treatment in Recurrent or Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients with Uncommon Epidermal Growth Factor Receptor Mutations (EGFRm).

Key Dates

Start date
Jan 19, 2022
Status verified
Sep 2025
Primary completion
Mar 9, 2023
Completion
Mar 9, 2023

Study Design

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

Arms

  • Experimental: Osimertinib plus standard chemotherapy
    single-arm

Primary Outcome Measure

ORR [ Time Frame: Due to study early terminated, actual time frame is up to 24 weeks. ]

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