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New targeted pill aims to keep KRAS lung cancer from returning after surgery

NCT ID NCT07541170

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This study tests whether the drug divarasib can prevent lung cancer from coming back in people with a specific gene mutation (KRAS G12C) who have already had surgery and chemotherapy. About 400 adults with stage II-III non-small cell lung cancer will be randomly assigned to receive divarasib, standard immunotherapy, or just observation. The goal is to see which approach works best for keeping the cancer away.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology * Participants must have had complete resection of NSCLC * Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy * Participants must be randomized within 12 weeks of their surgery date * No evidence of disease recurrence or metastatic disease * Documentation of the presence of a KRAS G12C mutation Exclusion Criteria: * Participants who achieve pCR following neoadjuvant treatment * Prior treatment with a KRAS inhibitor or any other anti-cancer therapy not otherwise specified in the protocol * Prior treatment with radiation therapy for NSCLC, with the exception of localized symptom-directed radiation prior to surgical resection * Resolved Grade 3 or greater immune-related AE or unresolved Grade 2 or greater immune-related AE from neoadjuvant immunotherapy * Active or history of autoimmune disease or immune deficiency * Significant cardiovascular disease

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Care Specialists

    RECRUITING

    Reno, Nevada, 89511, United States

  • Cenantron - Centro Avancado de Tratamento Oncologico

    RECRUITING

    Belo Horizonte, Minas Gerais, 30130-090, Brazil

  • Centro Oncologico Korben

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1426AGE, Argentina

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Jeollanam-do, 58128, South Korea

  • Clinica Adventista Belgrano

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1430EGF, Argentina

  • Clinica de Neoplasias Litoral

    RECRUITING

    Itajaí, Santa Catarina, 88301-220, Brazil

  • Community Cancer Institute (CCI)

    RECRUITING

    Clovis, California, 93611, United States

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, 21565, South Korea

  • Hospital Britanico

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1280AEB, Argentina

  • Hospital Sao Lucas - PUCRS

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Instituto Argentino de Diagnóstico y Tratamiento- IADT

    RECRUITING

    Capital Federal, C1122AAL, Argentina

  • Ospedale P. Pederzoli Casa di cura Privata

    RECRUITING

    Peschiera Del Garda (VR), Veneto, 37019, Italy

  • Piedmont Cancer Institute, PC

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Prince of Wales Hosp

    RECRUITING

    Shatin, Hong Kong

  • Profound Research, LLC

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Pusan National University Hospital

    RECRUITING

    Busan, 602-739, South Korea

  • Queen Mary Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • San Juan Oncology Associates

    RECRUITING

    Farmington, New Mexico, 87401, United States

  • Sanatorio de la Mujer

    RECRUITING

    Rosario, Santa Fe Province, S2000ORE, Argentina

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