Title: A phase II study of neoadjuvant sotorasib in combination with cisplatin or carboplatin and pemetrexed for surgically resectable stage IIA-IIIB non-squamous non-small cell lung cancer with a KRAS p.G12C mutation
Principal Investigator: Ferdinandos Skoulidis, MD, PhD, of MD Anderson Cancer Center in Houston
Description: Researchers are conducting a phase 2 study to evaluate neoadjuvant sotorasib in combination with cisplatin or carboplatin and pemetrexed for patients with KRAS p.G12C-mutant, nonsquamous non-small cell lung cancer (NSCLC).
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Patients will receive 4 cycles of at least 1 dose of sotorasib plus cisplatin or carboplatin and pemetrexed.
The primary objectives are to evaluate the efficacy of this induction regimen — as assessed by major pathologic response rate — and determine the safety, tolerability, and recommended phase 2 dose of sotorasib in combination with cisplatin/carboplatin and pemetrexed.
A secondary objective is to evaluate efficacy via objective response rate, event-free survival, recurrence-free survival, overall survival, complete resection, and pathologic complete response rate.
To be eligible for this study, patients must be 18 years of age or older. They must have previously untreated, stage IIA-IIIB nonsquamous NSCLC with a KRAS p.G12C mutation. For a complete list of eligibility criteria, please see the reference.
Status: Recruiting
This study is sponsored by MD Anderson Cancer Center in collaboration with Amgen.
Reference
ClinicalTrials.gov. A phase II study of neoadjuvant sotorasib in combination with cisplatin or carboplatin and pemetrexed for surgically resectable stage IIA-IIIB non-squamous non-small cell lung cancer with a KRAS p.G12C mutation. NCT05118854. Accessed May 22, 2023.
