Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge

Sponsor
Mark Vincent
Study ID
NCT04335292
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Osimertinib First-Line — DRUG
    Osimertinib, 80 mg, oral, daily
  • Platinum + Pemetrexed Chemotherapy Second-Line — DRUG
    Platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed are prescribed as per institutional standards.
  • Osimertinib Third-Line — DRUG
    Rechallenge with osimertinib, 80 mg, oral, daily

Study Details

This phase II single-armed study will examine the clinical utility of retreating patients with osimertinib, in the third-line, following first-line treatment with osimertinib and second-line treatment with platinum and pemetrexed chemotherapy. The current standard of care for first-line Epidermal Growth Factor Receptor (EGFR) mutated Advanced Non-Small Cell Lung Cancer (aNSCLC) is osimertinib, followed by cytotoxic chemotherapy. The repeat of osimertinib following previous treatment failure is investigational, although supported by scientific rationale. The dosing and scheduling of osimertinib follows its use in approved settings. The investigators examine its tolerability and efficacy in this setting to ensure osimertinib is a safe third-line option for patients with Epidermal Growth Factor Receptor mutated (EGFR+) Advanced Non-Small Cell Lung Cancer(aNSCLC).

Key Dates

Start date
Jan 6, 2021
Status verified
Oct 2024
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

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

Arms

  • Experimental: Treatment Arm
    First-line treatment = osimertinib, 80 mg, oral, daily; Second-line treatment = platinum (carboplatin or cisplatin) + pemetrexed chemotherapy, prescribed as per institutional standards; Third-line treatment = osimertinib rechallenge, 80 mg, oral, daily. Patients may enter the study at first-line treatment, second-line treatment, or third-line treatment. This is dependent on meeting the eligibility criteria.

Primary Outcome Measure

Objective Response Rate according to Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: End of study (approximately 4 years) ]

Central Contacts

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