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

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).

Conditions

Non-Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami (Data Collection Only), Miami, Florida, United States, 33136

Ann Arbor

University of Michigan (Data Collection Only), Ann Arbor, Michigan, United States, 48109

Basking Ridge

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, New York, United States, 11553

Allentown

Lehigh Valley Health Network (Dara Collection Only), Allentown, Pennsylvania, United States, 18103

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

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

Study Record Dates

2027-03