Completed

Sotorasib vs. Durvalumab for KRAS G12C Mutant Locally Advanced Non-small Cell Lung Cancer with Minimal Residual Disease

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Study Aim

This study aims to compare the effectiveness of Sotorasib and Durvalumab in treating locally advanced non-small cell lung cancer with KRAS G12C mutation and minimal residual disease, by evaluating the progression-free survival.

What is being tested

Durvalumab

+ Sotorasib

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2024
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 20, 2024

Actual date on which the first participant was enrolled.

This study focuses on patients with a type of lung cancer called non-small cell lung cancer that is locally advanced and has a specific mutation known as KRAS G12C. These patients are either about to start, are currently undergoing, or have just finished a combination of chemotherapy and radiation therapy. The study aims to determine whether switching to a medication called sotorasib is more effective than continuing with a treatment called durvalumab for patients who still have traces of cancer DNA in their blood after the initial treatment. This is important because finding a more effective treatment could potentially improve survival rates and outcomes for these patients. Participants in this study will first complete standard treatments as planned, which include chemotherapy and radiation therapy. If traces of cancer DNA are still detectable in their blood after these initial treatments and their cancer has not progressed, they will continue with durvalumab treatment. During this period, blood tests will measure any remaining cancer DNA. Those who still show traces of cancer DNA will be randomly assigned to either continue with durvalumab or switch to taking sotorasib pills daily. The study will monitor how long patients live without their cancer worsening to evaluate the effectiveness of each treatment. Patients switching to sotorasib will first stop durvalumab for 28 days before starting the new medication. The study aims to provide insights into which treatment option better prevents cancer from progressing.

Official TitleA Randomized Phase II Study of Sotorasib Versus Continued Consolidation Durvalumab in Patients With KRAS G12C Mutant Locally Advanced Non-small Cell Lung Cancer (LANSCLC) With Persistent ctDNA Defined Minimal Residual Disease
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

19 inclusion criteria required to participate
Completed definitive chemoradiation. Definitive radiation is defined as 56-70 Gy in 28-35 fractions concurrently with one of the following chemotherapy regimens: Carboplatin + pemetrexed, Cisplatin + pemetrexed, Paclitaxel + carboplatin, Cisplatin + etoposide

Must have a negative pregnancy test (serum or urine) within 3 days prior to the first dose of sotorasib (if assigned to Group 2)

Plan for, currently receiving, or recently completed definitive chemoradiation. Definitive radiation is defined as 56-70 Gy in 28-35 fractions concurrently with one of the following chemotherapy regimens: Carboplatin + pemetrexed, Cisplatin + pemetrexed, Paclitaxel + carboplatin, Cisplatin + etoposide

Detectable ctDNA measured within 8 weeks (+2 weeks) of completing definitive chemoradiation

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5 exclusion criteria prevent from participating
Other active malignancy (e.g. receiving active treatment) within the last year except for basal cell carcinoma of the skin and in situ malignancy even if without evidence of disease and patients on adjuvant hormonal therapies (e.g. breast, prostate), or bladder cancer with localized diseases

Prior pneumonitis

Physical limitation to undergo radiotherapy.

Pregnant or lactating women.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Will continue to receive durvalumab, 10 mg/kg IV every 2 weeks or 1500 mg/kg IV every 4 weeks for up to 12 months.

Group II

Experimental
Will receive sotorasib at 960 mg daily until progression. A dose de-escalation regimen based on toxicity will be implemented as below. If 120 mg cannot be tolerated, sotorasib will be discontinued and the patient will be removed from the trial.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

University of Miami (Data Collection Only)

Miami, United StatesOpen University of Miami (Data Collection Only) in Google Maps
Suspended

University of Michigan (Data Collection Only)

Ann Arbor, United States
Suspended

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, United States
Suspended

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, United States
Completed10 Study Centers