Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations

Sponsor
Fondazione Ricerca Traslazionale
Study ID
NCT04811001
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets
  • Dacomitinib — DRUG
    Vizimpro 15 mg film-coated tablets Vizimpro 30 mg film-coated tablets Vizimpro 45 mg film-coated tablets

Study Details

The best drug sequencing of dacomitinib or osimertinib in patients with advanced or metastatic Epidermal Growth Factor Receptor (EGFR) mutation positive non-small-cell lung cancer (NSCLC) has not yet been determined. The study enables investigation of the efficacy of dacomitinib followed by or subsequent to osimertinib osimertinib in patients with classical or uncommon activating EGFR mutations. Efficacy of dacomitinib will be defined in patients with asymptomatic or controlled brain metastases, special population eligible in this clinical trial.

Key Dates

Start date
Jun 12, 2020
Status verified
Feb 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Osimertinib->Dacomitinib)
    Osimertinib 80 mg/day until progression, unacceptable toxicity or patient refusal. At treatment discontinuation patients maintaining the original EGFR mutation will switch to Dacomitinib 45 mg/day until progression, unacceptable toxicity or patient refusal.
  • Experimental: Arm B (Dacomitinib->Osimertinib)
    Dacomitinib 45 mg/day until progression, unacceptable toxicity or patient refusal. At treatment discontinuation, patients harboring the EGFR-T790M will receive Osimertinib 80 mg/day until progression, unacceptable toxicity or patient refusal.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to 2 years since last patient enrolled ]

Central Contacts

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