Phase II Study of Sotorasib for KRAS p.G12C Non-Small Cell Lung Cancer
This study is for people with non-small cell lung cancer (NSCLC) that can be surgically removed, specifically those with a KRAS p.G12C gene mutation. It's testing a combination of medicines: sotorasib (AMG 510) along with either cisplatin or carboplatin, and pemetrexed. These drugs are given before surgery. The main goal is to see how well this combination shrinks the tumor before surgery, measured by how much cancer cells are gone in the removed tissue (major pathologic response rate). Researchers also want to understand the safety of this treatment. You must be at least 18 years old to participate.
- Study design
- This is a Phase II, single-arm study, meaning all 13 participants will receive the same treatment. It is also open-label, so both you and your doctors will know which treatments you are receiving.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal of the study is measured through study completion, which is an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
Active, Not Recruiting
PHASE2Ages 18+InterventionalSupportive careM.D. Anderson Cancer CenterInvestigator-initiated
~13 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:AMG 510CisplatinCarboplatinPemetrexed
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patients with surgically resectable KRAS p.G12C-mutant non-squamous NSCLC as assessed by major pathologic response rate in resected tumor specimens
Measured over through study completion, an average of 1 year
Conditions
Where it's being run
2 sites across 2 statesNew York1
Texas1
Study leadership
- Ferdinandos Skoulidis, MD,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
In case of mediastinal lymph nodes that are enlarged by CT criteria and/or PET-positive mediastinal lymph nodes.
In case of tumors \> 3 cm in maximum diameter
In case of centrally located tumors
For tumors with N1 nodes (cN1) Invasive mediastinal staging should include evaluation of contralateral stations 2 and/or 4 to exclude N3 disease as well as of subcarinal (station 7) lymph nodes. When there are no enlarged mediastinal lymph nodes by CT criteria and there is no uptake on PET/CT (cN0) direct surgical resection with lymph node dissection is indicated for tumors ≤ 3cm that are located in the outer third of the lung. 6. \[\*\] Absence of unequivocal evidence of stage IV disease based on contrast-enhanced CT chest, abdomen, pelvis or PET/CT and brain MRI with IV contrast (or contrast-enhanced CT of the head) performed within 60 days is sufficient for study registration but must be confirmed with whole-body PET/CT as well as contrast-enhanced CT chest and abdomen (or contrast-enhanced CT chest including the whole liver and both adrenal glands) and brain MRI with IV contrast (or contrast-enhanced CT of the head) within 28 days prior to the start of treatment. Patients with lesions that are considered equivocal for metastatic disease in the opinion of the local principal investigator are elibile to register and undergo molecular testing if they meet all other \[\*\] marked criteria but must meet the full trial eligibility criteria prior to study enrollment. In patients with severe allergy to iodinated contrast absence of stage IV disease on PET/CT and brain MRI with IV contrast performed within 28 days prior to enrollment suffices to satisfy this eligibility criterion. 7. \[\*\]Measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. 8. \[\*\]The patient must be a suitable candidate for surgery, in the opinion of the treating physician. 9. \[\*\]ECOG performance status score 0-1and life expectancy \> 3 months (in the opinion of the investigator). 10. \[\*\]Patients must be able to take oral medications and willing to record daily adherence to investigational product. 11. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 470 msec in females and QTcF ≤ 450 msec in males (based on average of screening triplicates performed within 5 minutes). 12. Subjects must have available (or accessible) and be willing to provide archival tumor tissue samples (formalin-fixed paraffin-embedded \[FFPE\] sample \[FFPE of excisional biopsy, core needle biopsy or fine needle aspirates\] collected within 5 years) or be willing to undergo pretreatment tumor biopsy (excisional, core needle, or fine needle aspirates) prior to enrollment.
Exclusion
Treated malignancy with no known active disease present for ≥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
Adequately treated non-melanoma skin cancer (basal or squamous cell cancer) or lentigo maligna without evidence of disease.
Adequately treated cervical carcinoma in situ without evidence of disease.
Adequately treated breast ductal carcinoma in situ without evidence of disease.
Prostatic intraepithelial neoplasia without evidence of prostate cancer.
Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ. 7. Major surgery within 28 days of cycle 1 day 1. In addition, patients with ongoing clinically relevant complications from prior surgery are not eligible and they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Sotorasib and for an additional 7 days after the last dose of sotorasib
Cisplatin (or Carboplatin) and Pemetrexed and for an additional 6 months after the last dose of cisplatin/carboplatin or pemetrexed. 32. \[\*\]Female subjects of childbearing potential unwilling to use one highly effective method of contraception (such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner). during treatment with:
Sotorasib and for an additional 7 days after the last dose of sotorasib
Cisplatin (or Carboplatin) and Pemetrexed and for an additional 6 months after the last dose of cisplatin/carboplatin or pemetrexed. 33. \[\*\]Female subjects of childbearing potential unwilling to use one highly effective method of contraception (such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner). during treatment with:
Sotorasib and for an additional 7 days after the last dose of sotorasib.
Cisplatin (or Carboplatin) and Pemetrexed and for an additional 6 months after the last dose of cisplatin/carboplatin or pemetrexed. Female subject of childbearing potential is defined as any female who has experienced menarche and who has not undergone surgicalsterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes 34. \[\*\]Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a serum pregnancy test and/or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG). 35. \[\*\]Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment with:
Sotorasib and for an additional 7 days after the last dose of sotorasib.
Cisplatin (or Carboplatin) and Pemetrexed and for an additional 3 months after the last dose of cisplatin (or carboplatin) and pemetrexed. 36. \[\*\]Male subjects with a pregnant partner who are unwilling to practice sexual abstinence or use a condom during heterosexual intercourse during treatment with:
Sotorasib and for an additional 7 days after the last dose of sotorasib.
Cisplatin (or Carboplatin) plus pemetrexed and for an additional 6 months after the last dose of cisplatin (or carboplatin) plus pemetrexed 37. \[\*\]Male subjects unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose of cisplatin (or carboplatin) and pemetrexed. 38. Vulnerable populations including prisoners and cognitively impaired adults.
What this trial measures
- Patients with surgically resectable KRAS p.G12C-mutant non-squamous NSCLC as assessed by major pathologic response rate in resected tumor specimensthrough study completion, an average of 1 year