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TerminatedPhase 2NCT06333678
Official study title

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

Study summary

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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDurvalumab and Sotorasib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 2, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Memorial Sloan Kettering Cancer Center
Interventions being studied
Drug: Durvalumab; Drug: Sotorasib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→
Treatment approach
Immunotherapy→Targeted therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Pre-Monitoring Phase
  • 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. Monitoring Phase
  • 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 Therapeutic Phase
  • 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).
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Miami (Data Collection Only)Miami, Florida
  • University of Michigan (Data Collection Only)Ann Arbor, Michigan
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking Ridge, New Jersey
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, New Jersey
  • Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, New Jersey
  • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)Commack, New York
  • Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, New York
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York
  • Memorial Sloan Kettering Nassau (All Protocol Activities)Uniondale, New York
  • Vanderbilt University (Data Collection Only)Nashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 2, 2026. Always confirm current availability with the study team.

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