NCT05118854 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
| NCT ID | NCT05118854 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2022-03-30 |
| Primary Completion | 2027-10-20 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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 treatment on study. Pure squamous cell carcinomas are not eligible but mixed histologies (for example adenosquamous carcinoma) are eligible. Sarcomatoid carcinomas are not eligible. Neuroendocrine carcinomas are not eligible. Carcinomas with neuroendocrine differentiation are eligible. Patients with mixed small-cell lung cancer and NSCLC are not eligible. 4. Identification of a KRAS p.G12C mutation in tum
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