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
M.D. Anderson Cancer Center
Summary
This is a phase II, single-arm, open-label study evaluating the efficacy, safety and tolerability of neoadjuvant sotorasib in combination with cisplatin (or carboplatin) and pemetrexed chemotherapy for patients with surgically resectable stage IIA - IIIB (T3-T4/N2) (based on AJCC 8th edition), non-squamous NSCLC with a KRAS p.G12C mutation. The primary objective of the study is to determine whether neoadjuvant therapy with 4 cycles of at least one dose of sotorasib plus cisplatin (or carboplatin) and pemetrexed can be administered safely and result in improved MPR rate in patients with KRAS p.G12C-mutant non-squamous NSCLC compared with the historical control MPR rate for platinum-based chemotherapy alone.
Description
Objectives Primary: * To evaluate the efficacy of induction with sotorasib (AMG 510) in combination with cisplatin (or carboplatin) and pemetrexed in patients with surgically resectable KRAS p.G12C-mutant non-squamous NSCLC as assessed by major pathologic response rate in resected tumor specimens. * To determine the safety, tolerability and RP2D of sotorasib in combination with cisplatin (or carboplatin) and pemetrexed as induction therapy in patients with surgically resectable KRAS p.G12C-mutant nonsquamous NSCLC Secondary: * To evaluate the efficacy of induction sotorasib in combination…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. \[\*\] Subject or subject's legally acceptable representative has provided signed and dated written informed consent prior to initiation of any study specific activities/procedures in accordance with ICH-GCP guidelines and the local legislation. 2. \[\*\]Age \> 18 years old. 3. \[\*\]Histologically or cytologically confirmed previously untreated non-squamous non-small cell lung cancer. If a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected lung cancer are eligible, but pathology must be confirmed prior to initiating treatme…
Interventions
- DrugAMG 510
Given by IV
- DrugCisplatin
Given by IV
- DrugCarboplatin
Given by IV
- DrugPemetrexed
Given by IV
Locations (2)
- Memorial Sloan Kettering Cancer CenterNew York, New York
- M D Anderson Cancer CenterHouston, Texas