COMPLETED

A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)

Conditions

Non-Small Cell Lung Cancer Sotorasib Durvalumab Locally advanced disease KRAS p.G12C mutation 22-321

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this study, the researchers will look at whether having participants switch from durvalumab to sotorasib when they have detectable minimal residual disease (MRD) is an effective treatment approach for locally advanced non-small cell lung cancer (LA-NSCLC). The researchers will see whether this switch to sotorasib can control LANSCLC longer compared to the treatment approach of staying on durvalumab (and not switching to sotorasib).

Official Title

A 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

Quick Facts

Study Start:2024-03-20

Study Completion:2026-01-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06333678

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologic diagnosis of NSCLC * Locally advanced disease, defined as AJCC 8th Edition Stage III disease. * 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 * KRAS p.G12C mutation identified through molecular testing * Adequate hepatic function, with adequate function defined as AST and ALT \< 2.5 x the upper limit of normal (ULN) * Patient eligible for consolidative durvalumab therapy * ECOG Performance status 0 - 2. * Age ≥ 18 years. * Patients must have decision-making capacity to consent to the study. * Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: \>/= 55 years old and no menses for 1\> year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral salpingectomy OR history of bilateral oophorectomy) or must be willing to comply with contraception requirements. * 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 * No evidence of radiographic progression, as measured through SOC imaging, as deemed by principal investigator, including a CT scan of the chest * ECOG Performance status 0 - 2. * Plan to start or already started durvalumab consolidation * No evidence of radiographic RECIST 1.1 progression, as measured through SOC imaging, as deemed by principal investigator, including a CT scan of the chest * MRD as measured by ctDNA testing (described above) * Candidate for sotorasib therapy * Must have a negative pregnancy test (serum or urine) within 3 days prior to the first dose of sotorasib (if assigned to Group 2).	* Serious medical co-morbidities precluding radiotherapy, determined at the discretion of the treating investigator. * Pregnant or lactating women. * Physical limitation to undergo radiotherapy. * 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

Inclusion Criteria

Exclusion Criteria

* Histologic diagnosis of NSCLC
* Locally advanced disease, defined as AJCC 8th Edition Stage III disease.
* 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
* KRAS p.G12C mutation identified through molecular testing
* Adequate hepatic function, with adequate function defined as AST and ALT \< 2.5 x the upper limit of normal (ULN)
* Patient eligible for consolidative durvalumab therapy
* ECOG Performance status 0 - 2.
* Age ≥ 18 years.
* Patients must have decision-making capacity to consent to the study.
* Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: \>/= 55 years old and no menses for 1\> year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral salpingectomy OR history of bilateral oophorectomy) or must be willing to comply with contraception requirements.
* 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
* No evidence of radiographic progression, as measured through SOC imaging, as deemed by principal investigator, including a CT scan of the chest
* ECOG Performance status 0 - 2.
* Plan to start or already started durvalumab consolidation
* No evidence of radiographic RECIST 1.1 progression, as measured through SOC imaging, as deemed by principal investigator, including a CT scan of the chest
* MRD as measured by ctDNA testing (described above)
* Candidate for sotorasib therapy
* Must have a negative pregnancy test (serum or urine) within 3 days prior to the first dose of sotorasib (if assigned to Group 2).

* Serious medical co-morbidities precluding radiotherapy, determined at the discretion of the treating investigator.
* Pregnant or lactating women.
* Physical limitation to undergo radiotherapy.
* 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

Contacts and Locations

Principal Investigator

Narek Shaverdian, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

University of Miami (Data Collection Only)

Miami, Florida, 33136

United States

University of Michigan (Data Collection Only)

Ann Arbor, Michigan, 48109

United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553

United States

Vanderbilt University (Data Collection Only)

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Narek Shaverdian, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-20

Study Completion Date2026-01-27

Study Record Updates

Study Start Date2024-03-20

Study Completion Date2026-01-27

Terms related to this study

Keywords Provided by Researchers

Sotorasib
Durvalumab
Locally advanced disease
KRAS p.G12C mutation
22-321

Additional Relevant MeSH Terms

Non-Small Cell Lung Cancer