A Study of Sotorasib in People With Non-Small Cell Lung Cancer
ConditionNon Small Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The researchers are doing this study to see if sotorasib is a safe and effective treatment for people with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have not received treatment for their cancer since it became advanced. (Participants have not received a "first-line therapy" since their cancer became advanced.)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
Biopsy-proven metastatic or recurrent non-small cell lung cancer
KRAS G12C mutation on prior tumor biopsy or cell-free DNA (cfDNA) testing
No prior therapy in the advanced setting
Disqualifiers
Symptomatic brain metastases
Any radiotherapy within 1 week of starting treatment on protocol
Any major surgery within 1 week of starting treatment on protocol
Exposure to prior adjuvant or consolidation anti-PD-1 or PD-(L)1 therapy for stage I-III disease within 12 weeks of start of initiation of sotorasib
Trial design
Design model
Single group
Treatments tested in this trial
Sotorasib
DrugSotorasib 960 mg (8 pills) daily
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: SotorasibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Response to therapy
will be assessed with serial CT chest/abdomen/pelvis every 2 cycles (6 weeks), with response evaluated by RECIST 1.1
Time frame
within 6 month of therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov