Combination Therapies with Adagrasib in Patients with Advanced NSCLC With KRAS G12C Mutation

Overview

About this study

The purpoes of this study is to evaluate the clinical effectiveness of combination therapies with adagrasib in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with TPS ≥ 1% and KRAS G12C mutation

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/5/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Konstantinos Leventakos, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Yanyan Lou, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20552259

Mayo Clinic Footer