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WCLC 2022 | NAUTIKA1: targeted therapies in biomarker-selected stage IB-II NSCLC

Jay M. Lee, MD, The Jonsson Comprehensive Cancer Center, University of California, Los Angeles, CA, shares the rationale behind the Phase II NAUTIKA1 trial (NCT04302025) investigating targeted therapies in stage II-III NSCLC. Targeted therapies for patients with non-small cell lung cancer (NSCLC) are currently being explored in clinical trials in the adjuvant setting. However, the role of targeted treatments in the neoadjuvant setting for patients with resectable NSCLC remains unclear. NAUTIKA1 aims to elucidate the efficacy of targeted treatment in the neoadjuvant setting in patients with resectable NSCLC with molecular alterations, including ALK, ROS1, NTRK, BRAF V600, and RET. In the ALK-positive cohort, patients with resectable stage II, IIIA or select IIIB NSCLC were treated with alectinib 600mg twice daily for 8 weeks as neoadjuvant treatment. The primary endpoint of this Phase II trial is major pathologic response and secondary endpoints include radiographic response, pathologic complete response, disease-free survival, event-free survival, overall survival, and safety. For this preliminary analysis, preliminary response, surgical outcomes, and safety data for the neoadjuvant period were assessed. This interview took place at the IASLC 2022 World Conference on Lung Cancer congress in Vienna, Austria.

Transcript (edited for clarity)

The NAUTIKA1 trial is a umbrella trial. It’s mainly comprised of cohorts with targeted therapies in the neoadjuvant space, followed by resection and then adjuvant targeted therapies. There are six different cohorts to NAUTIKA1. One is an immunotherapy arm for the PD-L1 positive group with atezo plus SBRT. All the other five cohorts are comprised of targets and associated targeted therapies...

The NAUTIKA1 trial is a umbrella trial. It’s mainly comprised of cohorts with targeted therapies in the neoadjuvant space, followed by resection and then adjuvant targeted therapies. There are six different cohorts to NAUTIKA1. One is an immunotherapy arm for the PD-L1 positive group with atezo plus SBRT. All the other five cohorts are comprised of targets and associated targeted therapies. These include alectinib for ALK. For the ROS1 and the NTRK cohorts, we are giving entrectinib. For the BRAF V600E target, we’re giving vemurafenib plus cobimetinib. And for RET, we’re giving pralsetinib. So six cohorts, the report at World Lung in 2022, our presentation is on the safety data for the alectinib or the ALK cohort only.

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