University of Kansas Medical Center

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

Cohort A* (closed): Has an untreated and unresectable or metastatic NSCLC with
histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically
confirmed PD-L1 TPS ≥1%.

- Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically
confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1
TPS < 50% AND previously completed 4 cycles of standard-of-care platinum based
induction chemotherapy with pembrolizumab AND experienced stable disease, partial
response, or complete response per investigator's assessment after 4 cycles OR if
patients received <4 cycles of a platinum-based induction, was stopped early due to
intolerable toxicity

- Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically
confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1
TPS < 50%

- Presence of measurable disease per RECIST v1.1

Exclusion Criteria:

- All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting

- Cohorts A & E: Prior systemic therapy for locally advanced or metastatic NSCLC,
including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy
(note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant
setting are allowed if last dose of prior systemic treatment was >1 year prior to
first dose of study treatment)

- Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed
following completion of 4-6 cycles of a platinum-based regimen administered in the
first-line setting

- Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment

- Active brain metastases