Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer

Sponsor
Yonsei University
Study ID
NCT06268210
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Lazertinib+Pemetrexed+Carboplatin — DRUG
    Lazertinib: 240 mg once daily (pre-/post-surgery for 3 years) Pemetrexed: 500 mg/m2 every 3 weeks (neoadjuvant therapy for 3 cycles) Carboplatin: AUC5 every 3 weeks (neoadjuvant therapy for 3 cycles)
  • Lazertinib — DRUG
    Lazertinib will be administered at a dosage of 240 mg once daily, both before and after surgery, for a duration of 3 years.

Study Details

In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with resectable, treatment-naive EGFR-mutant (exon 19 deletion or exon 21 L858R) non-small cell lung cancer, ranging from clinical stage IB to IIIB. The study is designed to assess the impact on pathological response, as well as effectiveness and safety considerations.

Key Dates

Start date
Feb 7, 2022
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: Experimental
    Patients will receive a combination therapy of Lazertinib and Pemed-S + Carboplatin as neoadjuvant treatment before surgery, followed by post-surgery maintenance with Lazertinib at a dosage of 240 mg once daily for a duration of 3 years. Dosages: Lazertinib: 240 mg once daily (pre-/post-surgery for 3 years) Pemetrexed: 500 mg/m2 every 3 weeks (neoadjuvant therapy for 3 cycles) Carboplatin: AUC5 every 3 weeks (neoadjuvant therapy for 3 cycles)
  • Active Comparator: Comparator
    Lazertinib will be administered at a dosage of 240 mg once daily, both before and after surgery, for a duration of 3 years.

Primary Outcome Measure

Primary pathological response [ Time Frame: After neo adjuvant treatment(3months) ]

Central Contacts

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