Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-05-04
27
Participants Needed
2
Research Sites
290 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided signed informed consent before starting study procedures
- Age over 18 years
- Histologically or cytologically confirmed previously untreated non-squamous NSCLC
- Presence of KRAS p.G12C mutation in tumor tissue or plasma confirmed by approved testing
- Disease stage IIA to select stage IIIB (T3-4N2) with surgical resectability confirmed
- No clear evidence of stage IV disease based on recent imaging
- Measurable disease by RECIST 1.1 criteria
- Suitable candidate for surgery as determined by treating physician
- ECOG performance status 0-1 with life expectancy over 3 months
- Able to take oral medications and willing to record daily adherence
- QTcF interval within specified limits for males and females
- Availability or willingness to provide tumor tissue samples
- Adequate blood counts and liver function within 10 days prior to study start
- Creatinine clearance of 60 mL/min or higher
You will not qualify if you...
- Prior systemic anticancer therapy or radiation for current lung cancer
- Pure squamous or predominantly squamous carcinoma histology
- Unresectable NSCLC as determined by multidisciplinary evaluation
- Stage IIIB N3, IIIC, IVA, or IVB NSCLC
- History or presence of hematological malignancies unless disease-free for 2+ years
- History of other malignancies except certain treated conditions with no active disease
- Major surgery within 28 days before treatment start or unresolved complications
- Significant cardiovascular disease including recent myocardial infarction or unstable conditions
- Gastrointestinal conditions preventing oral medication intake
- Recent serious infections requiring prolonged antibiotic or antiviral treatment
- History of interstitial lung disease or drug-induced pneumonitis
- Any serious medical disorder increasing risk or impairing study participation
- Moderate or severe sensorineural hearing loss unless carboplatin is used
- Grade 2 or higher peripheral neuropathy
- Unwillingness or inability to comply with study procedures
- Positive tests for hepatitis B or C infection
- Known HIV infection
- Recent live vaccine administration
- Regular illicit drug use or recent substance abuse
- Unwillingness to take corticosteroid premedication or vitamin supplements
- Use of certain medications affecting drug metabolism without approval
- History of severe allergic reactions to study drugs
- Brain metastases that cannot be excluded
- Pregnancy or breastfeeding, or unwillingness to use effective contraception
- Vulnerable populations such as prisoners or cognitively impaired adults
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Ferdinandos Skoulidis, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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